Cholecalciferol Supplementation, Muscle Strength

NCT00682214 | Completed Phase 1

• 1 other identifier: A-78/24.03.2008
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Vitamin D Deficiency

Keywords

25(OH)D, muscle strength

Outcome Measures

Primary Outcomes (1)

• Improvement in peripheral muscle Muscle strength by Cholecalciferol supplementation as revealed by muscle power and Magnetic resonance spectroscopic study

  Six months

Study Arms (2)

A, Choelcalciferol

ACTIVE COMPARATOR

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

B, Lactose

PLACEBO COMPARATOR

Drug: Lactose placebo

Interventions

Cholecalciferol DRUG

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

Also known as: Vitamin D

A, Choelcalciferol

Lactose placebo DRUG

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

Also known as: placebo granules and tablets

B, Lactose

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 20 years
• Residence of Delhi
• Commitment for follow-up at 8 weeks, 6 months \& 1 year.
• Consent for 8 weeks of 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

Sponsors & Collaborators

• Indian Council of Medical Research: lead

Related Publications (1)

• Gupta R, Sharma U, Gupta N, Kalaivani M, Singh U, Guleria R, Jagannathan NR, Goswami R. Effect of cholecalciferol and calcium supplementation on muscle strength and energy metabolism in vitamin D-deficient Asian Indians: a randomized, controlled trial. Clin Endocrinol (Oxf). 2010 Oct;73(4):445-51. doi: 10.1111/j.1365-2265.2010.03816.x.

  PMID: 20455886 RESULT

MeSH Terms

Conditions

Vitamin D Deficiency

Interventions

Cholecalciferol; Vitamin D; Tablets

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Secosteroids; Membrane Lipids; Lipids; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Ravinder Goswami, MD, DM

  Associate Professor, Department of Endocrinology and Metabolism, All India Institute of MEdical scieneces, New Delhi 110029

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: May 20, 2008
• First Posted: May 22, 2008
• Study Start: May 1, 2008
• Primary Completion: November 1, 2008
• Study Completion: June 1, 2009
• Last Updated: June 15, 2011

Record last verified: 2008-05