ObesityPhase 4NCT01199926

Effect of Vitamin D Supplementation on Muscle Mass and Function

A Phase 4 study testing Vitamin D in people with Obesity and Insulin Resistance, run by Purdue University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

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… Read more about this study

Who is it for?: Ages 18 to 35 yearsHealthy volunteers can take part
Conditions the study is for: Obesity, Insulin Resistance, Inflammation
What is being tested?: Vitamin D
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 34 participants
Where: 1 siteUnited States
Study dates: Aug 2008to Feb 2010
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 35 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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).

Trial locations and contacts

1 site in 1 country.

United States1 site

Wastl Human Performance Laboratory, Purdue University
West Lafayette, Indiana, 47907

Other trials in United States

About this study

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

Read the 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.

Conditions: Obesity, Insulin Resistance, Inflammation
Being tested: Vitamin D, Placebo
Keywords: 25-hydroxyvitamin D, Parathyroid hormone, Lean mass, Muscular strength, Glucose tolerance
Medical subject headings: Obesity, Insulin Resistance, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Vitamin DDietary supplement
Also called cholecalciferol
4000 IU of vitamin D per day for 12 weeks.
PlaceboDrug
Also called microcrystalline cellulose
Placebo (microcrystalline cellulose) ingestion each day for 12 weeks.

Study groups in NCT01199926
Study group	Role	What they receive
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. Receives: 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. Receives: Dietary Supplement: Vitamin D; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Muscle Function
The primary endpoint is the change in lean mass (kilograms) after the three month resistance exercise intervention.
Measured: 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.
Measured: three months
Inflammation
The primary endpoint is the change in C reactive protein after the three month intervention
Measured: three months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2008Feb 2010

First posted13 Sep 2010 (estimated)
Study startAug 2008
Primary completionJul 2009
Study completionFeb 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for ObesityStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 34 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01199926
Sponsor's protocol ID: GSSI-VitD (0801006402)
Status last verified: Apr 2015
First submitted: 9 Sep 2010
Last updated: 15 May 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 23034474

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)

All Obesity trials

Study at a glance

From the registry record, last updated by the sponsor on 15 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Impact of Vitamin D Supplementation on Strength and Lean Mass Accumulation During an Exercise Intervention
ClinicalTrials.gov ID: NCT01199926
Acronym / sponsor ID: GSSI-VitD (0801006402)
Conditions: Obesity, Insulin Resistance, Inflammation
Keywords: 25-hydroxyvitamin D, Parathyroid hormone, Lean mass, Muscular strength, Glucose tolerance
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 34 participants (actual)
Lead sponsor: Purdue UniversityUniversity, hospital or other
Study start: Aug 2008
Primary completion: Jul 2009 (actual)
Study completion: Feb 2010 (actual)
First posted: 13 Sep 2010 (estimated)
Results: Posted 15 May 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Vitamin D	Experimental	Dietary Supplement: Vitamin DParticipants in this arm consumed a 4000 IU vitamin D supplement daily for 12 weeks while participating in a resistance exercise training program.
Placebo	Placebo comparator	Dietary Supplement: Vitamin D, Drug: PlaceboParticipants in this arm consumed a placebo (microcrystalline cellulose) daily for 12 weeks while participating in a resistance exercise training program.

Who may qualify

Ages: 18 to 35 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (7 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Vitamin DAlso: cholecalciferol4000 IU of vitamin D per day for 12 weeks.	Dietary supplement	Placebo, Vitamin D
PlaceboAlso: microcrystalline cellulosePlacebo (microcrystalline cellulose) ingestion each day for 12 weeks.	Drug	Placebo

Primary outcome

Muscle Function
Time frame: three months
The primary endpoint is the change in lean mass (kilograms) after the three month resistance exercise intervention.
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.
Inflammation
Time frame: three months
The primary endpoint is the change in C reactive protein after the three month intervention

Results and safety

Results posted to the registry on 15 May 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Vitamin D	17	10
Placebo	17	13

Primary outcome: Muscle Function

Time frame: three months. Mean (Standard Deviation). Unit: kilograms

Measure	Vitamin D n = 10	Placebo n = 13
Value	1.14 (1.22)	1.50 (1.16)

Population analysed: Power statistical calculation was completed based on 80% power and error on lean mass measurement.

Primary outcome: Glucose Tolerance

Time frame: three months. Mean (Standard Deviation). Unit: mmol/L/120 min

Measure	Vitamin D n = 10	Placebo n = 13
Value	-18.0 (63.4)	-25.7 (31.1)

Population analysed: Power statistical calculation was completed based on 80% power and error on lean mass measurement.

Primary outcome: Inflammation

Time frame: three months. Mean (Standard Deviation). Unit: mg/L

Measure	Vitamin D n = 10	Placebo n = 13
Value	0.64 (1.62)	-0.33 (2.60)

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Vitamin D	0 of 0	0 of 0	Not reported
Placebo	0 of 0	0 of 0	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 23034474Carrillo 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.

Related trials for Obesity

RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Dorothy Teegarden, PhD principal investigator

Purdue University

Michael G Flynn, PhD principal investigator

College of Charleston

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Vitamin D in people with Obesity and Insulin Resistance, run by Purdue University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 May 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 May 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Muscle Function (time frame: three months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01199926, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2015.