drugset / Trial / NCT01190683

Vitamin D and Muscle Strength and Surface (Electromyography) EMG

NCT01190683

Phase 3 Completed 170 enrolled Indian Council of Medical Research
RandomizedParallel-groupTriple-blindHealth-services research

Summary

Vitamin D deficiency is widely prevalent in India. Serum 25(OH)D levels are \<20 ng /ml in up to 90% of them. Recently, in a randomized control trial, investigators have shown that dual cholecalciferol and calcium supplementation lead to significant improvement in hand grip strength and distance covered during six minutes walk test. Present study is being taken to further understand the functional significance of 25(OH)D in terms of its effect on Skeletal muscle strength including surface electromyography (EMG) in a larger cohort involving approximately 200 subjects. The impact of calcium and vitamin D supplementation would be assessed by supplementing them alone and in combination. Besides, the investigators would also assess impact of above supplementation on Th1/Th2 cytokines expression in the peripheral mononuclear cells.

Timeline

Start
2010-08
Primary completion
2011-04
Completion
2011-04

Drugs

EvaluationDrugModalityDoseRoute
Comparator Calcium carbonate Other / unclassified 1000 mg
Comparator Cholecalciferol Other / unclassified 60000 iu Oral

Indications