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Cholecalciferol Supplementation, Muscle Strength (MRVD)

This study has been completed.
Sponsor:
Information provided by:
Indian Council of Medical Research
ClinicalTrials.gov Identifier:
NCT00682214
First received: May 20, 2008
Last updated: June 14, 2011
Last verified: May 2008
History of Changes
  Purpose

Hypovitaminosis D is common in Asian Indians despite plenty of sunshine and relates to their skin pigmentation and poor sunshine exposure. Serum 25(OH)D levels are <20 ng /ml in up to 90% of them and therefore, based on the modern cut off, majority of apparently healthy normal Asian Indians would be classified as vitamin D deficient. Though, several investigators have highlighted the paradox of hypovitaminosis D in sunny Indian environment, there are only limited studies which have assessed its functional significance. To date, the significance of low serum 25(OH)D in them have been analyzed in terms of its inverse relationship with serum parathyroid hormone levels and variable association with reduced bone mineral content at hip and spine on DXA. Recently we have shown impairment in the absorption of intestinal calcium in 25(OH)D and its reversal after eight weeks of cholecalciferol supplementation. 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 its energy metabolism, bone mineral homeostasis and Th1/Th2 cytokines expression in Asian Indians with chronic biochemical hypovitaminosis D


Condition Intervention Phase
Vitamin D Deficiency
 Drug: Cholecalciferol
Drug: Lactose placebo
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Skeletal Muscle Strength Including Its Energy Metabolism, Bone Mineral Homeostasis and Th1/Th2 Cytokines Expression in Asian Indians With Chronic Hypovitaminosis D Before and After Oral Cholecalciferol Supplementation

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Improvement in peripheral muscle Muscle strength by Cholecalciferol supplementation as revealed by muscle power and Magnetic resonance spectroscopic study [ Time Frame: Six months ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: May 2008
Study Completion Date: June 2009
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A, Choelcalciferol
Drug: Cholecalciferol 60,000 IU sachet and calcium carbonate Oral cholecalciferol (vitamin D)60,000 IU weekly along with daily oral dose of 1 gm calcium carbonate for first two months followed by 1 gm of elemental calcium in form of calcium carbonate daily cholecalciferol (vitamin D)60,000 IU per month for the next four months
 Drug: Cholecalciferol
Drug: Cholecalciferol 60,000 IU sachet and calcium carbonate Oral cholecalciferol (vitamin D)60,000 IU weekly along with daily oral dose of 1 gm calcium carbonate for first two months followed by 1 gm of elemental calcium in form of calcium carbonate daily cholecalciferol (vitamin D)60,000 IU per month for the next four months
Other Name: Vitamin D
Placebo Comparator: B, Lactose Drug: Lactose placebo
Lactose placebo granules in identical sachet given weekly and two lactose tablets for first two months followed one sachet of placebo granules every month and two tablets of lactose containing placebo tablets taken daily for next four months
Other Name: placebo granules and tablets

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  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age > 20 years
  • Residence of Delhi
  • Commitment for follow-up at 8 weeks, 6 months & 1 year.
  • Consent for 8 weeks of 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00682214

Sponsors and Collaborators
Indian Council of Medical Research
Investigators
Principal Investigator: Ravinder Goswami, MD, DM Associate Professor, Department of Endocrinology and Metabolism, All India Institute of MEdical scieneces, New Delhi 110029
  More Information

Publications:

Responsible Party: Dr R Goswami, All India Institute of Medical sciences, New Delhi
ClinicalTrials.gov Identifier: NCT00682214     History of Changes
Other Study ID Numbers: A-78/24.03.2008
Study First Received: May 20, 2008
Last Updated: June 14, 2011
Health Authority: India: Institutional Review Board

Keywords provided by Indian Council of Medical Research:
25(OH)D, muscle strength

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

ClinicalTrials.gov processed this record on June 18, 2013