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Effect of Vitamin D Supplementation on Muscle Mass and Function

Primary Purpose

Obesity, Insulin Resistance, Inflammation

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Vitamin D

Placebo

About this trial

This is an interventional prevention trial for Obesity focused on measuring 25-hydroxyvitamin D, Parathyroid hormone, Lean mass, Muscular strength, Glucose tolerance

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

Wastl Human Performance Laboratory, Purdue University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Vitamin D

Placebo

Arm Description

Participants in this arm consumed a 4000 IU vitamin D supplement daily for 12 weeks while participating in a resistance exercise training program.

Participants in this arm consumed a placebo (microcrystalline cellulose) daily for 12 weeks while participating in a resistance exercise training program.

Outcomes

Primary Outcome Measures

Muscle Function

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

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.

Inflammation

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

Secondary Outcome Measures

Full Information

NCT ID

NCT01199926

First Posted

September 9, 2010

Last Updated

April 29, 2015

Sponsor

Purdue University

1. Study Identification

Unique Protocol Identification Number

NCT01199926

Brief Title

Effect of Vitamin D Supplementation on Muscle Mass and Function

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2015

Overall Recruitment Status

Completed

Study Start Date

August 2008 (undefined)

Primary Completion Date

July 2009 (Actual)

Study Completion Date

February 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Purdue University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity, Insulin Resistance, Inflammation

Keywords

25-hydroxyvitamin D, Parathyroid hormone, Lean mass, Muscular strength, Glucose tolerance

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

34 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Vitamin D

Arm Type

Experimental

Arm Description

Participants in this arm consumed a 4000 IU vitamin D supplement daily for 12 weeks while participating in a resistance exercise training program.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Participants in this arm consumed a placebo (microcrystalline cellulose) daily for 12 weeks while participating in a resistance exercise training program.

Intervention Type

Dietary Supplement

Intervention Name(s)

Vitamin D

Other Intervention Name(s)

cholecalciferol

Intervention Description

4000 IU of vitamin D per day for 12 weeks.

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

microcrystalline cellulose

Intervention Description

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

Primary Outcome Measure Information:

Title

Muscle Function

Description

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

Time Frame

three months

Title

Glucose Tolerance

Description

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.

Time Frame

three months

Title

Inflammation

Description

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

Time Frame

three months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

Eligibility 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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dorothy Teegarden, PhD

Organizational Affiliation

Purdue University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Michael G Flynn, PhD

Organizational Affiliation

College of Charleston

Official's Role

Principal Investigator

Facility Information:

Facility Name

Wastl Human Performance Laboratory, Purdue University

City

West Lafayette

State/Province

Indiana

ZIP/Postal Code

47907

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

23034474

Citation

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.

Results Reference

derived

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Effect of Vitamin D Supplementation on Muscle Mass and Function

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