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Vitamin D and Muscle Strength and Surface (Electromyography) EMG

This study has been completed.
Sponsor:
Information provided by:
Indian Council of Medical Research
ClinicalTrials.gov Identifier:
NCT01190683
First received: August 27, 2010
Last updated: June 14, 2011
Last verified: August 2010
  Purpose

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.


Condition Intervention Phase
Vitamin D Deficiency
Drug: Cholecalciferol
Drug: Calcium Carbonate
Drug: cholecalciferol and calcium carbonate
Other: lactose placebo
Other: lactose granules and tablets
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Indian Council of Medical Research:

Primary Outcome Measures:
  • Improvement in Muscle strength [ Time Frame: six months ] [ Designated as safety issue: Yes ]
    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


Enrollment: 170
Study Start Date: August 2010
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: cholecalciferol
cholecalciferol 60,000IU/week for first eight weeks followed by 60,000 IU every 15 days for four months along with calcium placebo
Drug: Cholecalciferol
60,000 IU/week for ist eight weeks followed by 60,000 IU every 15 days for four months
Other Name: Vitamin D
Drug: Calcium Carbonate
two tablets of calcium carbonate daily containing 1 gm of elemental calcium for six months
Other Name: Calcium
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 Name: vitamin D and calcium carbonate
Other: lactose granules and tablets
one sachet every week for eight weeks followed by two sachets every month along with two lactose tablets daily
Active Comparator: Calcium carbonate
two tablets of calcium carbonate daily equivalent to 1 gm of elemental calcium for six months along with vitamin D placebo
Drug: Calcium Carbonate
two tablets of calcium carbonate daily containing 1 gm of elemental calcium for six months
Other Name: Calcium
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 Name: vitamin D and calcium carbonate
Other: lactose granules and tablets
one sachet every week for eight weeks followed by two sachets every month along with two lactose tablets daily
Active Comparator: oral calcium and cholecalciferol
60,000 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
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 Name: vitamin D and calcium carbonate
Other: lactose granules and tablets
one sachet every week for eight weeks followed by two sachets every month along with two lactose tablets daily
Placebo Comparator: lactose
identical placebos
Other: lactose placebo
similar number of granules and tablets as active group
Other Name: lactose
Other: lactose granules and tablets
one sachet every week for eight weeks followed by two sachets every month along with two lactose tablets daily

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 18 years or more
  • Residence of Delhi
  • Commitment for follow-up at 8 weeks, 6 months.
  • Consent for supplementation

Exclusion Criteria:

  • Subjects taking drugs, which can affect bone mineral metabolism such as glucocorticoids, antitubercular, antiepileptics, levothyroxine, bisphosphonates
  • Chronic renal or liver disorder
  • Chronic diarrhea
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01190683

Sponsors and Collaborators
Indian Council of Medical Research
Investigators
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
  More Information

No publications provided

Responsible Party: Dr Ravinder Goswami, Additional Professor, Department of Endcrinology and Metabolism, All India Institute of Medical Sciences, New Delhi 110029
ClinicalTrials.gov Identifier: NCT01190683     History of Changes
Other Study ID Numbers: IEC/NP-216/2010
Study First Received: August 27, 2010
Last Updated: June 14, 2011
Health Authority: India: Indian Council of Medical Research

Additional relevant MeSH terms:
Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Calcium Carbonate
Calcium, Dietary
Cholecalciferol
Ergocalciferols
Vitamin D
Vitamins
Antacids
Bone Density Conservation Agents
Growth Substances
Micronutrients
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 25, 2014