Effect of Vitamin D Supplementation on Muscle Mass and Function

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dorothy Teegarden, Purdue University
ClinicalTrials.gov Identifier:
NCT01199926
First received: September 9, 2010
Last updated: April 29, 2015
Last verified: April 2015
  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
Obesity
Insulin Resistance
Inflammation
Dietary Supplement: Vitamin D
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 [ Time Frame: three months ] [ Designated as safety issue: Yes ]
    The primary endpoint is the change in lean mass (kilograms) after the three month resistance exercise intervention.

  • Glucose Tolerance [ Time Frame: three months ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    The primary endpoint is the change in C reactive protein after the three month intervention


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 D supplement daily for 12 weeks while participating in a resistance exercise training program.
Dietary Supplement: Vitamin D
4000 IU of vitamin D per day for 12 weeks.
Other Name: cholecalciferol
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: 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

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
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, Associate Dean Research and Grad. Prof. College of HHS, Purdue University
ClinicalTrials.gov Identifier: NCT01199926     History of Changes
Other Study ID Numbers: GSSI-VitD (0801006402)
Study First Received: September 9, 2010
Results First Received: April 29, 2015
Last Updated: April 29, 2015
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
Insulin Resistance
Glucose Metabolism Disorders
Hyperinsulinism
Metabolic Diseases
Pathologic Processes
Ergocalciferols
Vitamin D
Vitamins
Bone Density Conservation Agents
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 03, 2015