Vitamin D and Muscle Strength and Surface (Electromyography) EMG

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.

Conditions

• Vitamin D Deficiency

Interventions

DRUG

Cholecalciferol

60,000 IU/week for ist eight weeks followed by 60,000 IU every 15 days for four months

DRUG

Calcium Carbonate

two tablets of calcium carbonate daily containing 1 gm of elemental calcium for six months

DRUG

cholecalciferol and calcium carbonate

60,000 IU of cholecalciferol for first eight weeks and then 60,000IU for next four months along with 1 gm of elemental calcium daily for six months

OTHER

lactose placebo

similar number of granules and tablets as active group

OTHER

lactose granules and tablets

one sachet every week for eight weeks followed by two sachets every month along with two lactose tablets daily

Sponsors & Collaborators

• Indian Council of Medical Research

  lead OTHER_GOV

Principal Investigators

• Dr Ravinder Goswami, MD, DM · Associate Professor, Department of Endcorinology and Metabolism, All India Institute of Medical Sciences, New Delhi 110029, India

• Dr U Singh, MBBS, MD · Professor and Head, Department of Physcical Medicine and Rehablitation, All India Institute of Medical Sciences, New Delhi 110029, India

• Dr Nandita Dupta, PhD · Additional Professor, Department of Endocrinology and Metabolism, All India Institute of Medical Sciences, New delhi 110029, India

• Dr Manjari Tripathy, DM · Associate Professor, Department of Neurology, All India Institute of Medical Sciences, New Delhi 110029, India

• Dr Manju Vatsa · Principal, College of Nursing, All India Institute of Medical Sciences, New Delhi 110029, India

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

40 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2010-08-31

Primary Completion

2011-04-30

Completion

2011-04-30