Vitamin D and Muscle Strength and Surface (Electromyography) EMG
Skeletal Muscle Strength,Bone Mineral Homeostasis and Th1 and Th2 Cytokines Expression in Asian Indians With Chronic Hypovitaminosis D Before and After Oral Cholecalciferol Supplementation
1 other identifier
interventional
170
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Aug 2010
Shorter than P25 for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2010
CompletedFirst Submitted
Initial submission to the registry
August 27, 2010
CompletedFirst Posted
Study publicly available on registry
August 30, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2011
CompletedJune 15, 2011
August 1, 2010
8 months
August 27, 2010
June 14, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Improvement in Muscle strength
To assess change in upper and lower limb muscle strength by measiung hand grip, walking distance during six months of supplemnation with oral calcium carbonate alone, oral cholecalciferol alone, and dual supplemenation with oral cholecalciferol and calcium carbonate
six months
Study Arms (4)
cholecalciferol
ACTIVE COMPARATORcholecalciferol 60,000IU/week for first eight weeks followed by 60,000 IU every 15 days for four months along with calcium placebo
Calcium carbonate
ACTIVE COMPARATORtwo tablets of calcium carbonate daily equivalent to 1 gm of elemental calcium for six months along with vitamin D placebo
oral calcium and cholecalciferol
ACTIVE COMPARATOR60,000 IU of cholecalciferol every week for ist eight week and then 60,000IU every 15 days for next four months along with 1 gm of elemental calcium ever day for six months
lactose
PLACEBO COMPARATORidentical placebos
Interventions
60,000 IU/week for ist eight weeks followed by 60,000 IU every 15 days for four months
two tablets of calcium carbonate daily containing 1 gm of elemental calcium for six months
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
similar number of granules and tablets as active group
one sachet every week for eight weeks followed by two sachets every month along with two lactose tablets daily
Eligibility Criteria
You may qualify if:
- Age 18 years or more
- Residence of Delhi
- Commitment for follow-up at 8 weeks, 6 months.
- Consent for supplementation
You may not qualify if:
- Subjects taking drugs, which can affect bone mineral metabolism such as glucocorticoids, antitubercular, antiepileptics, levothyroxine, bisphosphonates
- Chronic renal or liver disorder
- Chronic diarrhea
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dr Ravinder Goswami, MD, DM
Associate Professor, Department of Endcorinology and Metabolism, All India Institute of Medical Sciences, New Delhi 110029, India
- PRINCIPAL INVESTIGATOR
Dr U Singh, MBBS, MD
Professor and Head, Department of Physcical Medicine and Rehablitation, All India Institute of Medical Sciences, New Delhi 110029, India
- PRINCIPAL INVESTIGATOR
Dr Nandita Dupta, PhD
Additional Professor, Department of Endocrinology and Metabolism, All India Institute of Medical Sciences, New delhi 110029, India
- PRINCIPAL INVESTIGATOR
Dr Manjari Tripathy, DM
Associate Professor, Department of Neurology, All India Institute of Medical Sciences, New Delhi 110029, India
- PRINCIPAL INVESTIGATOR
Dr Manju Vatsa
Principal, College of Nursing, All India Institute of Medical Sciences, New Delhi 110029, India
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
Study Record Dates
First Submitted
August 27, 2010
First Posted
August 30, 2010
Study Start
August 1, 2010
Primary Completion
April 1, 2011
Study Completion
April 1, 2011
Last Updated
June 15, 2011
Record last verified: 2010-08