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Effect of Vitamin D Supplementation on Muscle Mass and Function

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01199926
Recruitment Status : Completed
First Posted : September 13, 2010
Results First Posted : May 15, 2015
Last Update Posted : May 15, 2015
Sponsor:
Information provided by (Responsible Party):
Dorothy Teegarden, Purdue University

Tracking Information
First Submitted Date  ICMJE September 9, 2010
First Posted Date  ICMJE September 13, 2010
Results First Submitted Date  ICMJE April 29, 2015
Results First Posted Date  ICMJE May 15, 2015
Last Update Posted Date May 15, 2015
Study Start Date  ICMJE August 2008
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 29, 2015)
  • Muscle Function [ Time Frame: three months ]
    The primary endpoint is the change in lean mass (kilograms) after the three month resistance exercise intervention.
  • Glucose Tolerance [ Time Frame: three months ]
    The primary endpoint is the change in the area under the glucose curve following an oral glucose tolerance test prior to and after the three month intervention.
  • Inflammation [ Time Frame: three months ]
    The primary endpoint is the change in C reactive protein after the three month intervention
Original Primary Outcome Measures  ICMJE
 (submitted: September 10, 2010)
Muscle function, glucose tolerance, and inflammation [ Time Frame: three months ]
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).
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Vitamin D Supplementation on Muscle Mass and Function
Official Title  ICMJE Impact of Vitamin D Supplementation on Strength and Lean Mass Accumulation During an Exercise Intervention
Brief Summary 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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE
  • Obesity
  • Insulin Resistance
  • Inflammation
Intervention  ICMJE
  • Dietary Supplement: Vitamin D
    4000 IU of vitamin D per day for 12 weeks.
    Other Name: cholecalciferol
  • Drug: Placebo
    Placebo (microcrystalline cellulose) ingestion each day for 12 weeks.
    Other Name: microcrystalline cellulose
Study Arms  ICMJE
  • Experimental: Vitamin D
    Participants in this arm consumed a 4000 IU vitamin D supplement daily for 12 weeks while participating in a resistance exercise training program.
    Intervention: Dietary Supplement: 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.
    Interventions:
    • Dietary Supplement: Vitamin D
    • Drug: Placebo
Publications * Carrillo AE, Flynn MG, Pinkston C, Markofski MM, Jiang Y, Donkin SS, Teegarden D. Impact of vitamin D supplementation during a resistance training intervention on body composition, muscle function, and glucose tolerance in overweight and obese adults. Clin Nutr. 2013 Jun;32(3):375-81. doi: 10.1016/j.clnu.2012.08.014. Epub 2012 Aug 31.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 10, 2010)
34
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2010
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01199926
Other Study ID Numbers  ICMJE GSSI-VitD (0801006402)
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dorothy Teegarden, Purdue University
Study Sponsor  ICMJE Purdue University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dorothy Teegarden, PhD Purdue University
Principal Investigator: Michael G Flynn, PhD College of Charleston
PRS Account Purdue University
Verification Date April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP