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CTRI Number  CTRI/2014/07/004711 [Registered on: 03/07/2014] Trial Registered Prospectively
Last Modified On: 09/06/2016
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Process of Care Changes 
Study Design  Randomized Factorial Trial 
Public Title of Study   Vitamin D and calcium and muscle strength 
Scientific Title of Study   Vitamin D and calcium supplementation for improvement in skeletal muscle strength in young Asian Indian Males: A randomized controlled trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ravinder Goswami 
Designation  Professor,  
Affiliation  Department of Endocrinology and Metabolism, All India Institute of Medical Sciences, New Delhi 
Address  Ansari Nagar, New Delhi

New Delhi
DELHI
110029
India 
Phone  26594272  
Fax    
Email  gosravinder@hotmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ravinder Goswami 
Designation  Professor,  
Affiliation  Department of Endocrinology and Metabolism,All India Institute of Medical Sciences, New Delhi  
Address  Ansari Nagar, New Delhi

New Delhi
DELHI
110029
India 
Phone  26594272  
Fax    
Email  gosravinder@hotmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Ravinder Goswami 
Designation  Professor,  
Affiliation  Department of Endocrinology and Metabolism, All India Institute of Medical Sciences, 
Address  Ansari Nagar, New Delhi

New Delhi
DELHI
110029
India 
Phone  26594272  
Fax    
Email  gosravinder@hotmail.com  
 
Source of Monetary or Material Support  
Indian Council of Medical Reserach 
 
Primary Sponsor  
Name  Indian Council of Medical Research  
Address  Ansari Nagar, New Delhi 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr R Goswami  All India Institute of Medical Sciences  Dr R Goswami, Room #304, Biotechnology Block, 3rd floor, Department of Endocrinology, Ansari Nagar, AIIMS
New Delhi
DELHI 		 26594272

gosravinder@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Commitee, All India Institute of Medical Sciences, New Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Clinically asymptomatic but with low serum 25(OH)D 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Calcium Carbonate  Calcium carbonate tablets containing 500 mg elemental calcium each will be given twice daily for 6 months 
Intervention  Cholecalciferol   The dose of cholecalciferol will be 60,000 IU/wk for first 8week followed by 60,000 IU twice a month for 4 months 
Intervention  Cholecaliferol and Calcium Carbonate  The dose of cholecalciferol will be 60,000 IU/wk for first 8week followed by 60,000 IU twice a month for 4 months. Calcium carbonate tablets containing 500 mg elemental calcium each will be given twice daily for 6 months. Cholecalciferol granules and calcium tablets  
Comparator Agent  Placebos lactose  Placebo for both cholecalciferol and Calcium will be lactose granules and matched with active intrevention 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  25.00 Year(s)
Gender  Male 
Details  1. Age between 18 years and 25 years.
2. Currently residing in Delhi with commitment for follow-up for 6 months.
3. Written consent for randomization and supplementation after they have gone through project information sheet.
4: Apparently healthy with no history of chronic illness at any time or acute illness during the preceding two months. 
 
ExclusionCriteria 
Details  1. Subjects taking drugs which can affect bone mineral metabolism such as glucocorticoids, antitubercular, antiepileptics, levothyroxine, bisphosphonates, vitamin D and calcium supplementations
3. Those with history of any chronic renal or liver disorder or chronic diarrhea or any other chronic illness.
4. Subjects complaining of muscle aches and joint pain.
5. Serum total T4 and TSH suggestive of thyroid dysfunction.
 
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
Change in hand muscle grip strength   At six months of intervention 
 
Secondary Outcome  
Outcome  TimePoints 
Change in circulating testosterone with supplementation
 		 Baseline and at six months 
Correlation of hand grip, pinch grip and six minutes walk distance with circulating testosterone at baseline   Baseline 
Change in hand grip strength with change in circulating testosterone after six months of intervention with cholecalciferol with and without calcium supplementation
 		 Baseline and at six months 
 
Target Sample Size   Total Sample Size="228"
Sample Size from India="228" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   01/09/2014 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Vitamin D deficiency and its implications is currently an area of global interest (1-3). Hypovitaminosis D has been observed in Indians also, especially in urban area (4-7). Poor sunshine exposure and dark complexion of the skin are the major contributors (4). Presently, there is no food fortification program in India. This gives a unique opportunity to study potential implications of chronic vitamin D deficiency and the beneficial effects of supplementation in Indian population. Following initial demonstration of vitamin D deficiency in apparently healthy subjects in year 2000 (4), our center has been involved in investigating various effects of cholecalciferol supplementation especially those related to muscle strength (8-10). Two randomized control trials (RCT) have been carried out assessing the effect of cholecalciferol supplementation on muscle strength in Indians (9,10). The first pilot RCT comprising a group of 40 males and females aged 20-40 years showed improvement in the hand grip muscle strength following six months of cholecalciferol and calcium supplementation (9). In a subsequent better designed RCT carried out in 173 young females, there was no significant effect of cholecalciferol and calcium supplementation given alone or in combination on muscle strength (10). The variable results in these two RCTs indicate a possibility of gender specific effect in males. This could be confirmed in the retrospective analysis of the data of first RCT where males but not the females showed improvement in hand grip strength. There is a biological basis for such possible effect in males because of their higher circulating levels of testosterone and the recent demonstration of mild increase in circulating testosterone with cholecalciferol supplementation in them (11). The present RCT has been planned to look for the effect of cholecalciferol and calcium supplementation on muscle strength in young males. Though there are several such studies in elderly males (12), to the best of our knowledge, there is no similar study in young males. The present study has been planned to fill this lacunae taking into account the possible interaction between cholecalciferol and testosterone.

References

1.   Holick MF, Binkley NC, Bischoff-Ferrari HA, Gordon CM, Hanley DA, Heaney RP, Murad MH, Weaver CM.  Guidelines for preventing and treating vitamin D deficiency and insufficiency revisited. J Clin Endocrinol Metab 2012; 97:1153–58.

2.   Holick MF.Vitamin D deficiency in 2010: health benefits of vitamin D and sunlight: a Debate. Nat Rev Endocrinol  2011; 7:73–5.

3.   JC, Sai A, Templin T 2nd, Smith L. Dose response to vitamin D supplementation in postmenopausal women: a randomized trial. Ann Intern Med 2012; 156: 425–37.

 4.   Goswami R, Gupta N, Goswami D, Marwaha R K, Tandon N and Kochupillai N. Prevalence and significance of low 25-hydroxyvitamin D concentrations in healthy subjects in Delhi. Am J Clin Nutr 2000; 72: 472-5.

5.   Marwaha RK, Tandon N, Reddy DR. Vitamin D and bone mineral density status of healthy school children in northern India. Am J Clin Nutr 2005; 82: 477-82.

6.   Sachan A, Gupta R, Das V, Agarwal A, Awasthi PK, Bhatia V. High prevalence of vitamin D deficiency among pregnant women and their newborns in northern India. Am J Clin Nutr 2005; 81: 1060-4.

7.   Harinarayan CV. Prevalence of vitamin D deficiency in postmenopausal south Indian women. Osteoporos Int  2005; 16: 397-402.

8.   Gupta A, Gupta N, Singh N, Goswami R. Presence of impaired intestinal calcium absorption in chronic hypovitaminosis D and its change after cholecalciferol supplementation: assessment by the calcium load test. J Hum Nutr Diet. 2010; 23:54-60.

9.   Gupta R, Sharma U, Gupta N, Kalaivani M, Singh U, Guleria R, Jagannathan NR, Goswami R. Effect of cholecalciferol and calcium supplementation on muscle strength and energy metabolism in vitamin D-deficient Asian Indians: a randomized, controlled trial. Clin Endocrinol (Oxf) 2010; 73:445-51.

10.  Goswami R, Vatsa M, Sreenivas V, Singh U, Gupta N, Lakshmy R, Aggarwal S, Ganapathy A, Joshi P, Bhatia H. Skeletal muscle strength in young Asian Indian females after vitamin D and calcium supplementation: a double-blind randomized controlled clinical trial. J Clin Endocrinol Metab. 2012;97:4709-16.

11.  Pilz S, Frisch S, Koertke H, Kuhn J, Dreier J, Obermayer-Pietsch B, Wehr E,  Zittermann A. Effect of vitaminDsupplementation on testosterone levels in men. Horm Metab Res 2011; 43:223-5.

12.  Stockton KA, Mengersen K, Paratz JD, Kandiah D, Bennell KL.  Effect of vitamin D supplementation on muscle strength: a systematic review and meta-analysis. Osteoporos Int 2011; 22:859-71. 


 
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