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Effect of Vitamin D Supplementation on Muscle Mass and Function

This study has been completed.
Sponsor:
Collaborator:
Gatorade Sports Science Institute
Information provided by:
Purdue University
ClinicalTrials.gov Identifier:
NCT01199926
First received: September 9, 2010
Last updated: September 10, 2010
Last verified: September 2010
History of Changes
  Purpose

The study was designed to assess the effects of vitamin D supplementation during exercise training on body composition, muscle function, and glucose tolerance. The investigators hypothesis for these studies is that vitamin D supplementation enhances exercise-induced increases in strength and lean mass, potentially through enhancing insulin sensitivity and reducing inflammation.


Condition Intervention Phase
Vitamin D
Exercise
Muscles
Inflammation
 Dietary Supplement: cholecalciferol
Drug: Placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Impact of Vitamin D Supplementation on Strength and Lean Mass Accumulation During an Exercise Intervention

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Purdue University:

Primary Outcome Measures:
  • Muscle function, glucose tolerance, and inflammation [ Time Frame: three months ] [ Designated as safety issue: Yes ]
    The primary endpoint is lean mass accumulation, and the change muscular strength and peak muscle power; fasting glucose, insulin, and glucose tolerance; as well as inflammatory markers (CRP, TNFα and IL-6, and in vitro LPS-stimulated TNFα).


Enrollment: 34
Study Start Date: August 2008
Study Completion Date: February 2010
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vitamin D
Participants in this arm consumed a 4000 IU vitamin D3 supplement daily for 12 weeks while participating in a resistance exercise training program.
 Dietary Supplement: cholecalciferol
4000 IU of cholecalciferol per day for 12 weeks.
Other Name: Vitamin D
Placebo Comparator: Placebo
Participants in this arm consumed a placebo (microcrystalline cellulose) daily for 12 weeks while participating in a resistance exercise training program.
 Dietary Supplement: cholecalciferol
4000 IU of cholecalciferol per day for 12 weeks.
Other Name: Vitamin D
Drug: Placebo
Placebo (microcrystalline cellulose) ingestion each day for 12 weeks.

Detailed Description:

The study was designed to assess the effects of vitamin D supplementation during exercise training on body composition, muscle function, and glucose tolerance. It was a double-blind, randomized, placebo-controlled, clinical trial with participants randomized into either a 4,000 IU/day vitamin D or placebo group and all participants completed 12 wks (3 d/wk) of exercise training.

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Physical activity scores in the "low" to "very low" category
  • Fitness estimations in the "below average" or lower categories
  • body mass index scores >24.9 indicating overweight or obesity.

Exclusion Criteria:

  • Use of tanning booths or other artificial UV light exposure
  • High baseline vitamin D and calcium intake
  • Plans to visit sunny/warm destinations during the winter months/study period
  • History or presence of metabolic disease, type 2 diabetes, eating disorders, gastrointestinal disorders, pregnancy or lactation
  • Use of drugs to treat obesity (last 12 weeks)
  • Use of over the counter anti-obesity agents (last 12 weeks)
  • Recent initiation of an exercise program (last four weeks).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01199926

Locations
United States, Indiana
Wastl Human Performance Laboratory, Purdue University
West Lafayette, Indiana, United States, 47907
Sponsors and Collaborators
Purdue University
Gatorade Sports Science Institute
Investigators
Principal Investigator: Dorothy Teegarden, PhD Purdue University
Principal Investigator: Michael G Flynn, PhD College of Charleston
  More Information

No publications provided

Responsible Party: Dorothy Teegarden, Purdue University
ClinicalTrials.gov Identifier: NCT01199926     History of Changes
Other Study ID Numbers: GSSI-VitD (0801006402)
Study First Received: September 9, 2010
Last Updated: September 10, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Purdue University:
25-hydroxyvitamin D
Parathyroid hormone
Lean mass
Muscular strength
Glucose tolerance

Additional relevant MeSH terms:
Inflammation
Pathologic Processes
Cholecalciferol
Vitamin D
Ergocalciferols
Vitamins
 Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on June 18, 2013