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Muscle PowerPhase 4NCT01518725

The Effect of Vitamin D Supplementation on Muscle Power in Elite Cyclist

A Phase 4 study testing Vitamin D in people with Muscle Power, run by Oklahoma State 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
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Trial summary

The purpose of this study is to evaluate the change in vitamin D status with the change in muscular strength and muscular power in highly trained athletes over a 9-month study period. Read more about this study

Who is it for?
Ages 18 to 35 yearsHealthy volunteers can take part
Conditions the study is for
Muscle Power
What is being tested?
Vitamin D
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
103 participants
Where
1 siteUnited States
Study dates
Jan 2012to Aug 2013
Phase
Phase 4
Are there results?
None posted in the registry

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

  • Elite Cyclist (level 1,2 or 3)

Who cannot join

  • Currently prescribed vitamin D without physician approval to participate in study
  • Participants who respond "yes' to PAR-Q and do not get physician approval to participate in study

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Oklahoma State University

    Stillwater, Oklahoma, 74078

Other trials in United States

About this study

The purpose of this study is to evaluate the change in vitamin D status with the change in muscular strength and muscular power in highly trained athletes over a 9-month study period. The investigators hypothesize that the greatest muscular strength and power gains will be demonstrated in the athletes who achieve and maintain a 25(OH)-D > 50 ng/mL (but < 100 ng/mL) over the 6 month study duration.

This hypothesis will be tested by carrying out the following specific aims: Aim 1. to determine the extent to which increasing serum 25(OH)D to > 50 ng/mL is associated with improved muscular power by assessing specific performance measures (e.g. Vertical Jump Test and Wingate test) relative to lean body mass; and Aim 2. to examine the correlation between vitamin D status and muscular power over time.

Read the detailed description

Study will be advertised through flyers at the training facilities and by word of mouth. Researchers will schedule meeting with club members at the training facilities. At the meetings, the researchers will give an explanation of the study and address any concerns or questions that they may have. Cyclist will have an opportunity to sign up for participation on a sign-up sheet or e-mail the PI directly to minimize any chance of coercion. Meetings will take place in the training facilities in Tulsa, Oklahoma or the Oklahoma City Metropolitan Area. At this time, subjects will complete an informed consent along with demographic, anthropometric and health history, sunlight exposure, calcium and food frequency questionnaires and PAR Q. All subjects will be asked to fill out the questionnaires in the training facilities at various locations to ensure privacy. After completion of the appropriate questionnaires, cyclist will be have venous blood from the dominant arm (i.e., ~ 5 cc of blood) collected by a licensed medical professional and serum samples stored for future analysis of vitamin D metabolites (i.e., 25-OH-vitamin D and 1,25-OH-vitamin D) and parathyroid hormone (PTH) concentrations. The cyclist's arm will be cleaned with an alcohol swab, the blood will be drawn into a sterile vacutainer using a sterile needle. At the completion of blood collection, the arm will again be cleaned using sterile gauze and covered by a band aid to minimize the risk of infection. Samples will be placed on ice in an ice chest until they are processed in the Nutritional Sciences laboratories at Oklahoma State University. Subjects will then undergo skin tone analyses followed by evaluation of specific performance measures of muscular strength and power. These performance measures include: vertical jump test and a Wingate Power Test. All testing and blood collection will take place at the training facilities.

Within 4 weeks of completing the baseline assessment, the investigators will meet with the cyclist at their training facilities. Participants will be randomly assigned to placebo or the vitamin D supplemented group. The vitamin D supplementation will consist of 100 mcg of vitamin D/d, to be taken throughout the day. Participants will achieve 100 mcg by taking 2 x 25 mcg capsules per day. One will be taken at each time point (i.e., morning and evening) throughout the day. Currently, there is no evidence suggesting that athletes require more vitamin D then the general population for their age. Although we do not anticipate that the dose of vitamin D used in this study, will produce intoxication (150 ng/mL), subjects who exceed 100 ng/ml (i.e., upper end of the normal range) at any time will be asked to discontinue the study. Studies that have demonstrated the benefits of vitamin D supplementation on muscular strength and muscular power have combined vitamin D with calcium. Therefore, all subjects (placebo and vitamin D supplemented group) will be given a commercially available supplement of calcium and instructed to take with breakfast. The calcium supplement is in the form of calcium citrate (500 mg per capsule).

Conditions
Muscle Power
Being tested
Vitamin D, Placebo
Keywords
Muscle Power, Vitamin D, Vitamins, Cholecalciferol

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

    The vitamin D supplementation will consist of a capsule of 100 mcg of vitamin D/d, to be taken throughout the day. Participants will achieve 100 mcg by taking 2 x 25 mcg capsules per day. One will be taken at each time point (i.e., morning and evening) throughout the day. They will take the vitamin D supplement for the 6 month intervention period

  • PlaceboDietary supplement

    Participants in the placebo group will receive a capsule containing the inactive ingredients that include cellulose and silica to create a gel-like substance

Study groups in NCT01518725
Study groupRoleWhat they receive
Vitamin D SupplementationExperimentalThe vitamin D supplementation will consist of 100 mcg of vitamin D/d, to be taken throughout the day. Participants will achieve 100 mcg by taking 2 x 25 mcg capsules per day. One will be taken at each time point (i.e., morning and evening) throughout the day.
Receives: Dietary Supplement: Vitamin D
Gel-like SubstancePlacebo comparatorParticipants in the placebo group will receive a capsule containing the inactive ingredients that include cellulose and silica to create a gel-like substance
Receives: Dietary Supplement: Placebo

What is being measured

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

  1. Change in Vitamin D status from baseline to 3 months and 6 months

    Non fasting blood samples will be used for the evaluation of vitamin D metabolites. Venous blood (~5 cc) will be collected from the non-dominant arm by a trained phlebotomist, centrifuged at 2,000 rpm and serum stored at -80° C. Two vitamin D metabolites, 25 (OH) D and 1,25 (OH)2 D and serum PTH will be assessed.

    Measured: Up to 6 months

  2. Change in Power Output from baseline to 3 months and 6 months

    Power will be assessed using a Vertical Jump Test and a Wingate Power Test.

    Measured: Up to 6 months

Secondary outcomes (3)
  1. Sun Exposure Questionnaire

    Participants will complete a sun exposure questionnaire (SEQ) to estimate vitamin D synthesis. The SEQ is a 2 point questionnaire that assesses exposure in a week's time period. Sun exposure can be calculated by day and by week. This questionnaire is currently in press.

    Measured: Up to 6 months

  2. Skin Tone Measurement

    Skin tone will be assessed using the SmartProbe 400 for skin color measurement (IMS, Inc., Portland, ME). The measurement will be performed on the inner and outer portion of the forearm (dominant arm).

    Measured: Up to 6 months

  3. Food Frequency Questionnaire

    A food frequency questionnaire (FFQ) will estimate dietary vitamin D intake. The FFQ is a 12 point questionnaire that assesses vitamin D supplement usage and the intake of foods that are vitamin D rich.

    Measured: Up to 6 months

Timeline

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

  1. First posted26 Jan 2012 (estimated)
  2. Study startJan 2012
  3. Primary completionAug 2013
  4. Study completionAug 2013

Resources

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
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
103 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01518725
Sponsor's protocol ID
ED11189
Status last verified
Apr 2015
First submitted
18 Jan 2012
Last updated
29 Apr 2015
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Vitamin D in people with Muscle Power, run by Oklahoma State 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 1 inclusion and 2 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 29 Apr 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Change in Vitamin D status from baseline to 3 months and 6 months (time frame: Up to 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 29 Apr 2015.

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