Vitamin D and calcium and muscle strength

Phase 2/3

Completed

Conditions: Clinically asymptomatic but with low serum 25(OH)D

Registration Number: CTRI/2014/07/004711

Lead Sponsor: Indian Council of Medical Research

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; 97:1153â€“58.**

**2.   Holick MF.Vitamin D deficiency in 2010: health benefits of vitamin D and sunlight: a Debate. *Nat Rev Endocrinol* 2011; 7:73â€“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: 425â€“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.**

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Male

Target Recruitment: 228

Inclusion Criteria

Age between 18 years and 25 years.
Currently residing in Delhi with commitment for follow-up for 6 months.
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.

Exclusion Criteria

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.
Subjects complaining of muscle aches and joint pain.
Serum total T4 and TSH suggestive of thyroid dysfunction.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in hand muscle grip strength	At six months of intervention

Secondary Outcome Measures

Name	Time	Method
Change in circulating testosterone with supplementation
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

Trial Locations

Locations (1): All India Institute of Medical Sciences
🇮🇳
Delhi, DELHI, India
All India Institute of Medical Sciences
🇮🇳Delhi, DELHI, India
Dr R Goswami
Principal investigator
gosravinder@hotmail.com