NCT01199926

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for phase_4 obesity

Timeline
Completed

Started Aug 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 13, 2010

Completed
4.7 years until next milestone

Results Posted

Study results publicly available

May 15, 2015

Completed
Last Updated

May 15, 2015

Status Verified

April 1, 2015

Enrollment Period

11 months

First QC Date

September 9, 2010

Results QC Date

April 29, 2015

Last Update Submit

April 29, 2015

Conditions

ObesityInsulin ResistanceInflammation

Keywords

25-hydroxyvitamin DParathyroid hormoneLean massMuscular strengthGlucose tolerance

Outcome Measures

Primary Outcomes (3)

  • Muscle Function

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

    three months

  • 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

  • Inflammation

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

    three months

Study Arms (2)

Vitamin D

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Vitamin DDrug: Placebo

Interventions

Vitamin DDIETARY_SUPPLEMENT

4000 IU of vitamin D per day for 12 weeks.

Also known as: cholecalciferol
PlaceboVitamin D
PlaceboDRUG

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

Also known as: microcrystalline cellulose
Placebo

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wastl Human Performance Laboratory, Purdue University

West Lafayette, Indiana, 47907, United States

Location

Related Publications (1)

  • 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.

    PMID: 23034474DERIVED

MeSH Terms

Conditions

ObesityInsulin ResistanceInflammation

Interventions

Vitamin DCholecalciferolmicrocrystalline cellulose

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesPathologic Processes

Intervention Hierarchy (Ancestors)

SecosteroidsSteroidsFused-Ring CompoundsPolycyclic CompoundsCholestenesCholestanesSterolsMembrane LipidsLipids

Results Point of Contact

Title
Dr. Dorothy Teegarden
Organization
Purdue University
teegarden@purdue.edu
765-494-8791

Study Officials

  • Dorothy Teegarden, PhD

    Purdue University

    PRINCIPAL INVESTIGATOR

  • Michael G Flynn, PhD

    College of Charleston

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Dean Research and Grad. Prof. College of HHS

Study Record Dates

First Submitted

September 9, 2010

First Posted

September 13, 2010

Study Start

August 1, 2008

Primary Completion

July 1, 2009

Study Completion

February 1, 2010

Last Updated

May 15, 2015

Results First Posted

May 15, 2015

Record last verified: 2015-04

Locations

US(1)