Effect of Vitamin D Supplementation on Muscle Mass and Function

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01199926
• Other study ID #: GSSI-VitD (0801006402)
• Status: Completed
• Phase: Phase 4
• First received: September 9, 2010
• Last updated: April 29, 2015
• Start date: August 2008
• Est. completion date: February 2010

Study information

• Verified date: April 2015
• Source: Purdue University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: February 2010
• Est. primary completion date: July 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 35 Years

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Inflammation
• Insulin Resistance
• Obesity

Intervention

Dietary Supplement:
• Vitamin D
4000 IU of vitamin D per day for 12 weeks.

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

Locations

Country	Name	City	State
United States	Wastl Human Performance Laboratory, Purdue University	West Lafayette	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Purdue University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Muscle Function	The primary endpoint is the change in lean mass (kilograms) after the three month resistance exercise intervention.	three months	Yes
Primary	Glucose Tolerance	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.	three months	Yes
Primary	Inflammation	The primary endpoint is the change in C reactive protein after the three month intervention	three months	Yes