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Completed

NCT Number: NCT01199926

Effect of Vitamin D Supplementation on Muscle Mass and Function

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.

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Key information

Conditions

Obesity Body Weight Glucose Metabolism Disorders Hyperinsulinism Inflammation Insulin Resistance Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Wastl Human Performance Laboratory, Purdue University

West Lafayette, Indiana, 47907, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Vitamin D

Dietary Supplement

4000 IU of vitamin D per day for 12 weeks.

Other names: cholecalciferol

Placebo

Drug

Placebo (microcrystalline cellulose) ingestion each day for 12 weeks.

Other names: microcrystalline cellulose

Primary outcomes

  1. Muscle Function

    Time frame: three months

    The primary endpoint is the change in lean mass (kilograms) after the three month resistance exercise intervention.

  2. 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.

  3. Inflammation

    Time frame: three months

    The primary endpoint is the change in C reactive protein after the three month intervention

Sponsors and collaborators

Lead sponsor

Purdue University

Other

Registry information

Official study title

Impact of Vitamin D Supplementation on Strength and Lean Mass Accumulation During an Exercise Intervention

Important dates

Study start
2008
Primary completion
2009
Study completion
2010
First posted
Sep 13, 2010
Registry last updated
May 15, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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