Journal of Clinical and Diagnostic Research, ISSN - 0973 - 709X

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Dr Mohan Z Mani

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On Sep 2018




Prof. Somashekhar Nimbalkar

"Over the last few years, we have published our research regularly in Journal of Clinical and Diagnostic Research. Having published in more than 20 high impact journals over the last five years including several high impact ones and reviewing articles for even more journals across my fields of interest, we value our published work in JCDR for their high standards in publishing scientific articles. The ease of submission, the rapid reviews in under a month, the high quality of their reviewers and keen attention to the final process of proofs and publication, ensure that there are no mistakes in the final article. We have been asked clarifications on several occasions and have been happy to provide them and it exemplifies the commitment to quality of the team at JCDR."



Prof. Somashekhar Nimbalkar
Head, Department of Pediatrics, Pramukhswami Medical College, Karamsad
Chairman, Research Group, Charutar Arogya Mandal, Karamsad
National Joint Coordinator - Advanced IAP NNF NRP Program
Ex-Member, Governing Body, National Neonatology Forum, New Delhi
Ex-President - National Neonatology Forum Gujarat State Chapter
Department of Pediatrics, Pramukhswami Medical College, Karamsad, Anand, Gujarat.
On Sep 2018




Dr. Kalyani R

"Journal of Clinical and Diagnostic Research is at present a well-known Indian originated scientific journal which started with a humble beginning. I have been associated with this journal since many years. I appreciate the Editor, Dr. Hemant Jain, for his constant effort in bringing up this journal to the present status right from the scratch. The journal is multidisciplinary. It encourages in publishing the scientific articles from postgraduates and also the beginners who start their career. At the same time the journal also caters for the high quality articles from specialty and super-specialty researchers. Hence it provides a platform for the scientist and researchers to publish. The other aspect of it is, the readers get the information regarding the most recent developments in science which can be used for teaching, research, treating patients and to some extent take preventive measures against certain diseases. The journal is contributing immensely to the society at national and international level."



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Sri Devaraj Urs Medical College
Sri Devaraj Urs Academy of Higher Education and Research , Kolar, Karnataka
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Dr. Saumya Navit

"As a peer-reviewed journal, the Journal of Clinical and Diagnostic Research provides an opportunity to researchers, scientists and budding professionals to explore the developments in the field of medicine and dentistry and their varied specialities, thus extending our view on biological diversities of living species in relation to medicine.
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Dr Saumya Navit
Professor and Head
Department of Pediatric Dentistry
Saraswati Dental College
Lucknow
On Sep 2018




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"My sincere attachment with JCDR as an author as well as reviewer is a learning experience . Their systematic approach in publication of article in various categories is really praiseworthy.
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It's a honour and pride to be a part of the JCDR team. My very best wishes to JCDR and hope it will sparkle up above the sky as a high indexed journal in near future."



Dr. Arunava Biswas
MD, DM (Clinical Pharmacology)
Assistant Professor
Department of Pharmacology
Calcutta National Medical College & Hospital , Kolkata




Dr. C.S. Ramesh Babu
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Best regards,
C.S. Ramesh Babu,
Associate Professor of Anatomy,
Muzaffarnagar Medical College,
Muzaffarnagar.
On Aug 2018




Dr. Arundhathi. S
"Journal of Clinical and Diagnostic Research (JCDR) is a reputed peer reviewed journal and is constantly involved in publishing high quality research articles related to medicine. Its been a great pleasure to be associated with this esteemed journal as a reviewer and as an author for a couple of years. The editorial board consists of many dedicated and reputed experts as its members and they are doing an appreciable work in guiding budding researchers. JCDR is doing a commendable job in scientific research by promoting excellent quality research & review articles and case reports & series. The reviewers provide appropriate suggestions that improve the quality of articles. I strongly recommend my fraternity to encourage JCDR by contributing their valuable research work in this widely accepted, user friendly journal. I hope my collaboration with JCDR will continue for a long time".



Dr. Arundhathi. S
MBBS, MD (Pathology),
Sanjay Gandhi institute of trauma and orthopedics,
Bengaluru.
On Aug 2018




Dr. Mamta Gupta,
"It gives me great pleasure to be associated with JCDR, since last 2-3 years. Since then I have authored, co-authored and reviewed about 25 articles in JCDR. I thank JCDR for giving me an opportunity to improve my own skills as an author and a reviewer.
It 's a multispecialty journal, publishing high quality articles. It gives a platform to the authors to publish their research work which can be available for everyone across the globe to read. The best thing about JCDR is that the full articles of all medical specialties are available as pdf/html for reading free of cost or without institutional subscription, which is not there for other journals. For those who have problem in writing manuscript or do statistical work, JCDR comes for their rescue.
The journal has a monthly publication and the articles are published quite fast. In time compared to other journals. The on-line first publication is also a great advantage and facility to review one's own articles before going to print. The response to any query and permission if required, is quite fast; this is quite commendable. I have a very good experience about seeking quick permission for quoting a photograph (Fig.) from a JCDR article for my chapter authored in an E book. I never thought it would be so easy. No hassles.
Reviewing articles is no less a pain staking process and requires in depth perception, knowledge about the topic for review. It requires time and concentration, yet I enjoy doing it. The JCDR website especially for the reviewers is quite user friendly. My suggestions for improving the journal is, more strict review process, so that only high quality articles are published. I find a a good number of articles in Obst. Gynae, hence, a new journal for this specialty titled JCDR-OG can be started. May be a bimonthly or quarterly publication to begin with. Only selected articles should find a place in it.
An yearly reward for the best article authored can also incentivize the authors. Though the process of finding the best article will be not be very easy. I do not know how reviewing process can be improved. If an article is being reviewed by two reviewers, then opinion of one can be communicated to the other or the final opinion of the editor can be communicated to the reviewer if requested for. This will help one’s reviewing skills.
My best wishes to Dr. Hemant Jain and all the editorial staff of JCDR for their untiring efforts to bring out this journal. I strongly recommend medical fraternity to publish their valuable research work in this esteemed journal, JCDR".



Dr. Mamta Gupta
Consultant
(Ex HOD Obs &Gynae, Hindu Rao Hospital and associated NDMC Medical College, Delhi)
Aug 2018




Dr. Rajendra Kumar Ghritlaharey

"I wish to thank Dr. Hemant Jain, Editor-in-Chief Journal of Clinical and Diagnostic Research (JCDR), for asking me to write up few words.
Writing is the representation of language in a textual medium i e; into the words and sentences on paper. Quality medical manuscript writing in particular, demands not only a high-quality research, but also requires accurate and concise communication of findings and conclusions, with adherence to particular journal guidelines. In medical field whether working in teaching, private, or in corporate institution, everyone wants to excel in his / her own field and get recognised by making manuscripts publication.


Authors are the souls of any journal, and deserve much respect. To publish a journal manuscripts are needed from authors. Authors have a great responsibility for producing facts of their work in terms of number and results truthfully and an individual honesty is expected from authors in this regards. Both ways its true "No authors-No manuscripts-No journals" and "No journals–No manuscripts–No authors". Reviewing a manuscript is also a very responsible and important task of any peer-reviewed journal and to be taken seriously. It needs knowledge on the subject, sincerity, honesty and determination. Although the process of reviewing a manuscript is a time consuming task butit is expected to give one's best remarks within the time frame of the journal.
Salient features of the JCDR: It is a biomedical, multidisciplinary (including all medical and dental specialities), e-journal, with wide scope and extensive author support. At the same time, a free text of manuscript is available in HTML and PDF format. There is fast growing authorship and readership with JCDR as this can be judged by the number of articles published in it i e; in Feb 2007 of its first issue, it contained 5 articles only, and now in its recent volume published in April 2011, it contained 67 manuscripts. This e-journal is fulfilling the commitments and objectives sincerely, (as stated by Editor-in-chief in his preface to first edition) i e; to encourage physicians through the internet, especially from the developing countries who witness a spectrum of disease and acquire a wealth of knowledge to publish their experiences to benefit the medical community in patients care. I also feel that many of us have work of substance, newer ideas, adequate clinical materials but poor in medical writing and hesitation to submit the work and need help. JCDR provides authors help in this regards.
Timely publication of journal: Publication of manuscripts and bringing out the issue in time is one of the positive aspects of JCDR and is possible with strong support team in terms of peer reviewers, proof reading, language check, computer operators, etc. This is one of the great reasons for authors to submit their work with JCDR. Another best part of JCDR is "Online first Publications" facilities available for the authors. This facility not only provides the prompt publications of the manuscripts but at the same time also early availability of the manuscripts for the readers.
Indexation and online availability: Indexation transforms the journal in some sense from its local ownership to the worldwide professional community and to the public.JCDR is indexed with Embase & EMbiology, Google Scholar, Index Copernicus, Chemical Abstracts Service, Journal seek Database, Indian Science Abstracts, to name few of them. Manuscriptspublished in JCDR are available on major search engines ie; google, yahoo, msn.
In the era of fast growing newer technologies, and in computer and internet friendly environment the manuscripts preparation, submission, review, revision, etc and all can be done and checked with a click from all corer of the world, at any time. Of course there is always a scope for improvement in every field and none is perfect. To progress, one needs to identify the areas of one's weakness and to strengthen them.
It is well said that "happy beginning is half done" and it fits perfectly with JCDR. It has grown considerably and I feel it has already grown up from its infancy to adolescence, achieving the status of standard online e-journal form Indian continent since its inception in Feb 2007. This had been made possible due to the efforts and the hard work put in it. The way the JCDR is improving with every new volume, with good quality original manuscripts, makes it a quality journal for readers. I must thank and congratulate Dr Hemant Jain, Editor-in-Chief JCDR and his team for their sincere efforts, dedication, and determination for making JCDR a fast growing journal.
Every one of us: authors, reviewers, editors, and publisher are responsible for enhancing the stature of the journal. I wish for a great success for JCDR."



Thanking you
With sincere regards
Dr. Rajendra Kumar Ghritlaharey, M.S., M. Ch., FAIS
Associate Professor,
Department of Paediatric Surgery, Gandhi Medical College & Associated
Kamla Nehru & Hamidia Hospitals Bhopal, Madhya Pradesh 462 001 (India)
E-mail: drrajendrak1@rediffmail.com
On May 11,2011




Dr. Shankar P.R.

"On looking back through my Gmail archives after being requested by the journal to write a short editorial about my experiences of publishing with the Journal of Clinical and Diagnostic Research (JCDR), I came across an e-mail from Dr. Hemant Jain, Editor, in March 2007, which introduced the new electronic journal. The main features of the journal which were outlined in the e-mail were extensive author support, cash rewards, the peer review process, and other salient features of the journal.
Over a span of over four years, we (I and my colleagues) have published around 25 articles in the journal. In this editorial, I plan to briefly discuss my experiences of publishing with JCDR and the strengths of the journal and to finally address the areas for improvement.
My experiences of publishing with JCDR: Overall, my experiences of publishing withJCDR have been positive. The best point about the journal is that it responds to queries from the author. This may seem to be simple and not too much to ask for, but unfortunately, many journals in the subcontinent and from many developing countries do not respond or they respond with a long delay to the queries from the authors 1. The reasons could be many, including lack of optimal secretarial and other support. Another problem with many journals is the slowness of the review process. Editorial processing and peer review can take anywhere between a year to two years with some journals. Also, some journals do not keep the contributors informed about the progress of the review process. Due to the long review process, the articles can lose their relevance and topicality. A major benefit with JCDR is the timeliness and promptness of its response. In Dr Jain's e-mail which was sent to me in 2007, before the introduction of the Pre-publishing system, he had stated that he had received my submission and that he would get back to me within seven days and he did!
Most of the manuscripts are published within 3 to 4 months of their submission if they are found to be suitable after the review process. JCDR is published bimonthly and the accepted articles were usually published in the next issue. Recently, due to the increased volume of the submissions, the review process has become slower and it ?? Section can take from 4 to 6 months for the articles to be reviewed. The journal has an extensive author support system and it has recently introduced a paid expedited review process. The journal also mentions the average time for processing the manuscript under different submission systems - regular submission and expedited review.
Strengths of the journal: The journal has an online first facility in which the accepted manuscripts may be published on the website before being included in a regular issue of the journal. This cuts down the time between their acceptance and the publication. The journal is indexed in many databases, though not in PubMed. The editorial board should now take steps to index the journal in PubMed. The journal has a system of notifying readers through e-mail when a new issue is released. Also, the articles are available in both the HTML and the PDF formats. I especially like the new and colorful page format of the journal. Also, the access statistics of the articles are available. The prepublication and the manuscript tracking system are also helpful for the authors.
Areas for improvement: In certain cases, I felt that the peer review process of the manuscripts was not up to international standards and that it should be strengthened. Also, the number of manuscripts in an issue is high and it may be difficult for readers to go through all of them. The journal can consider tightening of the peer review process and increasing the quality standards for the acceptance of the manuscripts. I faced occasional problems with the online manuscript submission (Pre-publishing) system, which have to be addressed.
Overall, the publishing process with JCDR has been smooth, quick and relatively hassle free and I can recommend other authors to consider the journal as an outlet for their work."



Dr. P. Ravi Shankar
KIST Medical College, P.O. Box 14142, Kathmandu, Nepal.
E-mail: ravi.dr.shankar@gmail.com
On April 2011
Anuradha

Dear team JCDR, I would like to thank you for the very professional and polite service provided by everyone at JCDR. While i have been in the field of writing and editing for sometime, this has been my first attempt in publishing a scientific paper.Thank you for hand-holding me through the process.


Dr. Anuradha
E-mail: anuradha2nittur@gmail.com
On Jan 2020

Important Notice

Original article / research
Year : 2022 | Month : June | Volume : 16 | Issue : 6 | Page : RC01 - RC04 Full Version

Comparing the Effectiveness of Oral versus Intramuscular Vitamin D Supplementation in Adults with Fracture around Hip and Vitamin D Deficiency


Published: June 1, 2022 | DOI: https://doi.org/10.7860/JCDR/2022/56181.16475
Sidhant Chhabra, Anand Sharma, Som Pratap Gupta, Ashwani Bilandi, Mohit Meena, Ashwani Kumar Mathur

1. Junior Resident, Department of Orthopaedics, Mahatma Gandhi Medical College and Hospital, Jaipur, Rajasthan, India. 2. Associate Professor, Department of Orthopaedics, Mahatma Gandhi Medical College and Hospital, Jaipur, Rajasthan, India. 3. Professor and Head of Department, Department of Orthopaedics, Mahatma Gandhi Medical College and Hospital, Jaipur, Rajasthan, India. 4. Senior Resident, Department of Orthopaedics, Mahatma Gandhi Medical College and Hospital, Jaipur, Rajasthan, India. 5. Assistant Professor, Department of Orthopaedics, Mahatma Gandhi Medical College and Hospital, Jaipur, Rajasthan, India. 6. Professor, Department of Orthopaedics, Mahatma Gandhi Medical College and Hospital, Jaipur, Rajasthan, India.

Correspondence Address :
Dr. Ashwani Kumar Mathur,
Professor, Department of Orthopaedics, Mahatma Gandhi Medical College and
Hospital, Jaipur, Rajasthan, India.
E-mailashwanimathur@hotmail.com

Abstract

Introduction: Cholecalciferol plays vital role in bone mineralization. Major circulating and storage form of vitamin D is 25-hydroxycholecalciferol {25(OH)D3} which is formed in the liver after 25-hydroxylation. It is also the form of vitamin D that is measured in blood tests to detect deficiency of vitamin D. There is scarcity of literature to support the best therapy at the lowest effective dose that is practicable, cost efficient, and devoid of probable side effects. Oral medication compliance is a major stumbling block to replenishing vitamin D levels in the body. Vitamin D administered intramuscularly (i.m.) may be able to overcome this limitation.

Aim: To compare the effectiveness of oral versus intramuscular vitamin D in adults with fracture around hip and vitamin D deficiency.

Materials and Methods: This prospective interventional study was conducted in Orthopaedics Ward in Mahatma Gandhi Institute of Medical Sciences, Jaipur, Rajasthan, India, from January 2020 to June 2021. Total 60 male and female, above 18 years, with fractures around the hip and vitamin D levels less 30 ng/mL were included in the study. In group O (n=30) patient received oral vitamin D supplementation of 60000 IU once a week for 6 weeks . In group I (n=30) patient received single dose of 600000 IU vitamin D injection (i.m.). Follow-up of patients was done at baseline, 6 weeks and 12 weeeks for serum values of vitamin D, calcium, alkaline phosphatase and parathyroid hormone levels. Bivariate analytical techniques has been used to measure the improvement of group I with group O.

Results: The mean age in group I was 60.40±16.38 years and in group O was 59.47±15.17 years (p-value=0.82). There were total 31 females, 13 in group I and 18 in group O. No significant difference was observed among the groups in vitamin D level at the baseline, {group I: 13.84 ± 3.54 ng/mL; group O: 16.45 ± 6.3 ng/mL, p-value=0.053}. At 6 weeks, the mean value of the vitamin D significantly increased in both groups (p-value=0.001; group I: 40.94±4.67 ng/mL and group O: 33.64±9.89 ng/mL). At the 12th week, the mean value of the vitamin D was significantly higher in group I (44.52±7.09 ng/mL) compared to group O (24.65±10.92 ng/mL), p-value<0.001. The vitamin D mean was significantly raised with the time in group I and group O at 6 weeks and still remained increased at 12 weeks in group I but not in group O.

Conclusion: The present study concluded that although both administration routes are effective and appear to be safe, intramuscular application is more effective in increasing 25(OH)D levels and sustaining it for a longer period of time as compared to oral dose.

Keywords

Bone metabolism, Cholecalciferol, Effective dose, Osteoporosis

Vitamin D plays a very significant role in bone metabolism and mineralization. It is a fat soluble vitamin, leads to its effects by acting on vitamin D receptors (1). Lesser mineralization of bones leads to rickets and osteomalacia (2). It has a preventive role in various diseases like in cancer, infection, autoimmune illness, cardiovascular diseases, and diabetes mellitus, among other non skeletal disorders (3).

The high prevalence of hypovitaminosis D among pregnant women and children is a major concern. Weather changes has also reflected changes in vitamin D levels (4). In large cities, air pollution probably also plays a role (5). Urban subjects are found to be more deficient in vitamin D (6). One-fifth of them also have indications of parathyroid hyperactivity, as measured by PTH levels in the blood (7). Their hypovitaminosis D is caused by a lack of sunlight exposure and skin pigmentation (8). There are studies which have shown decreased levels of vitamin D in neonates, healthy school girls, hospital staff, pregnant women in North India (5),(8),(9),(10).

In most of the studies, the criteria used for defining hypovitaminosis (vitamin D Deficiency) is serum 25(OH)D level below 50 nmol/L (9),(10),(11). Various vitamin D deficiency and insufficiency diseases have been highlighted (12). In adults, this can lead to decreased mineralization that is Osteomalacia. Decreased levels also leads to increased incidences of hip fractures muscle weakness thus affecting the mobility and functional ability of the person (13),(14). Prevention of such eventualities is feasible by adequate sunlight exposure, food fortification and supplementation of vitamin D for at risk population as a cost-effective measure in prevention of hip and other geriatric fractures.There is need for optimizing vitamin D levels in cases of osteoporosis patients given antiresorptives (bisphosphonate) and anabolic (teriparatide) drugs (15). Active vitamin D works in tandem with two additional hormones to maintain calcium and phosphate homeostasis and Parathyroid Hormone (PTH) (16).

Physicians in India are currently prescribing a 1500 mg cholecalciferol sachet to be taken once a week for 1 to 8 weeks for overt or occult vitamin D insufficiency (17).

Its short-term and long-term effects on serum 25(OH)D levels in Asian Indians, however, have not been well investigated. There is a scarcity of scientific literature to support the best therapy at the lowest effective dose, that is practicable, cost-efficient and devoid of probable side effects. Persistence is very low with oral vitamin D supplementation (18). Oral medication compliance is a major stumbling block to replenishing vitamin D levels in the body. Vitamin D administered intramuscularly (i.m.) may be able to overcome this limitation. Vitamin D i.m. injections are regularly available in the market in two values (3 lac and 6 lac IU). Parenteral route (intramuscular) of administration of vitamin D has lead to effective increase in vitamin D levels but this cannot be administered without monitoring serum levels (19).

Supplementation, either oral or intramuscular, is a more realistic and easier way to receive enough vitamin D. However, no study comparing intramuscular injection and oral vitamin D dosage in Indian people has been conducted. Hence, present study was conducted to evaluate the efficacy and tolerability of oral cholecalciferol (60,000 IU) versus i.m. cholecalciferol (600,000 IU) in correcting vitamin D deficiency with fracture around hip.

Material and Methods

This prospective interventional study was conducted among patients, admitted to Orthopaedics Ward in Mahatma Gandhi Institute of Medical Sciences, Jaipur, Rajasthan, India, from January 2020 to June 2021. The study was permitted by Institutional Ethics Committee (MGMCH/IEC/JPR/2020/100).

Inclusion criteria: All males and females above 18 years of age, with hip fractures and vitamin D levels less than 30 ng/mL were included in the study (2).

Exclusion criteria: The patients taking Hormone Replacement Therapy (HRT) or anticonvulsants, with chronic debilitating illness {Chronic Obstructive Pulmonary Disease (COPD), cancer, Acquired Immune Deficiency Syndrome (AIDS), Congestive Heart Failure (CHF)}, renal disease (creatinine level >1.5 mg/dL), liver disease (bilirubin >2 mg/dL), malabsorption syndrome and patients with gastrectomy/steroid dependency were excluded from the study.

Sample size calculation: For sample size calculation, power was taken as 80%, from similar previous study by Gupta N et al., where they have used 40 samples, 20 in each arms with power 80% and level of significance 5% (20). In present study, 10 more samples in each group 30 (total n= 60) were taken.

A total 60 patients were divided equally into two groups (30 patients each group). Randomization was done by chit in box method.

• Group O (n=30): Received oral vitamin D supplementation of 60,000 IU once a week for 6 weeks.
• Group I (n=30): Received i.m. vitamin D supplementation with a single dose of 6,00,000 IU vitamin D injection.

Procedure

A 10 mL of fasting blood samples were collected for measurement of serum vitamin D, serum calcium (albumin-adjusted) and serum Parathyroid Hormone (PTH), Alkaline Phosphatase (ALP) levels.

1. Serum 25(OH)D level was determined by radioimmunoassay method (19).

• Vitamin D deficiency: <10 ng/mL
• Insufficiency: 10- 29 ng/mL
• Optimal: ≥30 ng/mL

3. Serum calcium was measured with the enzymatic method using automated spectrophotometer the reference range for serum calcium is 2.20-2.60 mmol/L (21).

Follow-up was done for oral vitamin D, intramuscular vitamin D, PTH level and calcium at baseline, at 6 weeks and at 12 weeks.

Statistical Analysis

Continuous data were summarized in the form of mean and their standard deviation. Difference in change in means of two groups were analysed using student’s t-test (difference in differential analysis). Intragroup analysis of means at multiple time duration was analysed using Analysis of Variance (ANOVA). Count data were expressed in form of proportions. Difference among proportions were analysed using Chi-square test. The level of significance was kept 95% for all statistical analysis. Statistical Package for Social Sciences (SPSS) software version 14.0 (Inc.,Chicago, IL, USA) was used for all analytics works.

Results

The groups were comparable according to age and sex demographics. Mean age in group I was 60.40±16.38 years and in group O was 59.47±15.17 years (p-value=0.82). There were total 31 females, 13 in group I and 18 in group O (Table/Fig 1). In present study, 52 (86.67%) were found to be vitamin D deficient and 8 (13.33%) were vitamin D insufficient.

At baseline, no significant difference was observed between the groups for vitamin D (p-value=0.053). At 6th week, the mean value of the vitamin D increased in both groups. Mean value was significantly higher in group I (40.94±4.67 ng/mL) as compared to group O (33.64±9.89 ng/mL) (p-value=0.001). At 12th week, the mean value of the vitamin D was significantly higher in Group I (44.52±7.09 ng/mL) as compared to Group O (24.65±10.92 ng/mL) with p-value <0.001 (Table/Fig 2).

Statistically no significant difference was observed in the Calcium level at baseline, 6th week and 12th week during follow-up between the groups as shown in (Table/Fig 3).

(Table/Fig 4) shows the difference in ALP values over time between two groups. Baseline values in the two groups were comparable. At 6th week, the mean value of the ALP decreased from the baseline in both the Group I and Group O. No significant difference was observed between the groups at 6th week (p-value=0.506) and 12th weeks (p-value=0.495).

(Table/Fig 5) depicts the difference in PTH values over time between two groups. No Significant changes were observed in the serum PTH levels at baseline (p-value=0.170). At 6th week, the mean value of the PTH decreased from the baseline in both the group I and group O. No significant difference was observed between the groups at 6th week (p-value=0.801) and 12th week (p-value=0.371).

Discussion

In present study, 86.67 % were found to be vitamin D deficient and 13.33% were Vitamin D insufficient according to Holick MF (Global Prospective 2013) (2).

Zhang D et al., did the study on 527 patients, 71% of the patients with fracture had low vitamin D levels (22). In a study by Hershkovitz A et al., 92.6% of the patients had lower cholecalciferol levels, in which 78.2% were vitamin D deficient and 14.4% were vitamin D insufficient. 6.8% of the patients had optimal vitamin D level. Cholecalciferol deficiency was found in 20.3% of the patients (23).

The vitamin D mean value was significantly raised with the time in group I and group O at 6th weeks and still remained increased at 12th weeks in group I but not in group O which implied better results in vitamin D level in group I, as compared to group O. Billoo A et al., and Hashemipour S et al., have done similar studies comparing two different routes for Vitamin D supplementation and found similar results (24),(25).

Previous studies by Robertson DS et al.,; Gupta N et al., and Lakkireddy M et al., reported similar observations regarding the safety, efficacy and acceptability of a single dose of vitamin D versus oral vitamin D (20),(26),(27). Vitamin D (cholecalciferol) was found to be helpful in both oral and injectable forms. The vitamin D value at 6th weeks increased for both groups 40.94±4.67 ng/mL for group I and 33.64±9.89 ng/mL for group O as compared to their baseline values which were 13.84±3.54 ng/mL and 16.45±6.3 ng/mL for group I and group O respectively.

Although the results after administration of injectable form were statistically significant as at 12th weeks vitamin D values sustained and showed increase in injectable group compared to group O as evident from the values 44.52±7.09 ng/mL for group I and 24.65± 10.92 ng/mL for group O. There were no negative side effects, and both treatment options were well tolerated.

Significant changes were observed in the serum calcium levels from baseline within the groups which declined at 6th weeks followed by rise at 12th weeks. Statistically no significant difference was observed in the mean calcium levels between both the groups at 12th weeks. These observations were similar with studies conducted by Mittal H et al., (28). They investigated the non-inferiority of a lower therapeutic dose (3,00,000 IU) of vitamin D for boosting blood 25(OH) D levels when compared to a conventional dose (600,000 IU) (28). They discovered hypercalcemia in two children at 4th weeks (one in each group) and three children at 12th weeks (one in group 1 and two in group 2). It was concluded that initially calcium level were decreased initially and then increased.

Difference was observed in the serum ALP from baseline within the groups. The mean serum ALP which in both the groups decreased at 6th and 12th weeks. Statistically no significant difference was observed in the mean ALP levels between both the groups at 12th weeks. This was similar to the outcome of the study conducted by Mittal H et al, both the groups demonstrated significant (p-value<0.05) and comparable fall in the serum alkaline phosphatase levels at 12th weeks (28).

Vitamin D deficiency have been observed to often have raised serum PTH levels. The mean serum PTH respectively in the group I and group O which showed a significant decrease in the levels at 6th weeks and 12th weeks. Statistically no significant difference was observed in the mean PTH levels between both the groups at 12 weeks. The PTH values were higher than normal range in many patients and may be attributed to higher ages of the subjects. This finding is consistent with that reported by Haden ST et al., where it was observed that both the study groups demonstrated significant (p-value <0.05) and comparable fall in the serum parathormone levels at 12 weeks. Relative change {ratio of geometric mean (95% CI)} in serum PTH, 12th weeks after therapy, were 0.98 (0.7-1.47) (29). Choi HK et al., assessed the efficacy and safety of high-dose vitamin D3 after intramuscular injection and found that decreased levels of PTH in the vitamin D3 group when compared to control group (30). Haden ST et al., also observed that in both the groups, efficacious PTH suppression were observed. A single intramuscular dose of vitamin D3 had no meaningful effect on parathyroid hormone. It was concluded that both the groups showed statistically significant suppression of PTH from baseline (29).

Reduced vitamin D levels may also have a role in the occurrence of hip fractures in these older people, especially if they also have osteoporosis, as suggested by the data. These studies demonstrated that calcium and vitamin D supplementation is safe and induced a moderate reduction in femoral neck bone loss associated with a substantial reduction of the risk of hip fracture in elderly ambulatory women. Previous research by Sanfelix-Genovés J et al., and Diez A et al., has shown that oral vitamin D replacement has a low rate of compliance (31),(32). Pearce SH and Cheetham TD, suggested an i.m. dose of 300,000 IU cholecalciferol once a month for 3 months followed by the same dose once or twice a year in patients with severe malabsorption (33). The pharmacokinetics of i.m. D3 delivery, as well as the lack of 25(OH)D level variations after i.m. treatment, makes it a good therapeutic choice for people who have obesity, malabsorption, or compliance issues as suggested by Vieth R (34). Kaur P et al., found that excessive doses and injudicious usage of the parenteral route, on the other hand, may be linked to problems including hypercalcemia, hypercalciuria, and vitamin D toxicity (35).

Limitation(s)

Outcome of hip fractures could not be taken into consideration on oral versus intramuscular vitamin D injection.

Conclusion

Present study established an association between hypovitaminosis D and intramuscular injection of vitamin D. It was concluded that although both administration routes are effective and appear to be safe, intramuscular application is more effective in increasing 25(OH)D levels and sustaining it for a longer period of time as compared to oral dose. Identifying and treating these patients early with vitamin D for osteomalacia and anti osteoporotic regimens for osteoporosis will improve the bone, muscle and overall health thereby reducing falls and fractures. Studies on larger scale are needed to be carried out to set the inferences on right dosage of vitamin D.

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DOI and Others

DOI: 10.7860/JCDR/2022/56181.16475

Date of Submission: Mar 09, 2022
Date of Peer Review: Mar 22, 2022
Date of Acceptance: May 09, 2022
Date of Publishing: Jun 01, 2022

AUTHOR DECLARATION:
• Financial or Other Competing Interests: None
• Was Ethics Committee Approval obtained for this study? Yes
• Was informed consent obtained from the subjects involved in the study? Yes
• For any images presented appropriate consent has been obtained from the subjects. NA

PLAGIARISM CHECKING METHODS:
• Plagiarism X-checker: Mar 13, 2022
• Manual Googling: May 02, 2022
• iThenticate Software: May 19, 2022 (25%)

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