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

History of Changes

Tracking Information

First Received Date ^ICMJE

September 9, 2010

Last Updated Date

September 10, 2010

Start Date ^ICMJE

August 2008

Primary Completion Date

July 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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).

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01199926 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

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

Phase 4

Study Design ^ICMJE

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

Condition ^ICMJE

Vitamin D
Exercise
Muscles
Inflammation

Intervention ^ICMJE

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.

Study Arm (s)

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.

Intervention: Dietary Supplement: 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.
Interventions:
- Dietary Supplement: cholecalciferol
- Drug: Placebo

Publications *

Not Provided

* 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

Enrollment ^ICMJE

Completion Date

February 2010

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).

Gender

Both

Ages

18 Years to 35 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01199926

Other Study ID Numbers ^ICMJE

GSSI-VitD (0801006402)

Has Data Monitoring Committee

Responsible Party

Dorothy Teegarden, Purdue University

Study Sponsor ^ICMJE

Purdue University

Collaborators ^ICMJE

Gatorade Sports Science Institute

Investigators ^ICMJE

Principal Investigator:	Dorothy Teegarden, PhD	Purdue University
Principal Investigator:	Michael G Flynn, PhD	College of Charleston

Information Provided By

Purdue University

Verification Date

September 2010

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

To Top