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
  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:


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
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: 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 by Purdue University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
Ergocalciferols
Vitamin D
Vitamins
Bone Density Conservation Agents
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 20, 2014