Muscle Power Clinical Trial
Official title:
The Effect of Vitamin D Supplementation on Muscle Power in Elite Cyclist
Verified date | April 2015 |
Source | Oklahoma State University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 103 |
Est. completion date | August 2013 |
Est. primary completion date | August 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 35 Years |
Eligibility |
Inclusion Criteria: - Elite Cyclist (level 1,2 or 3) Exclusion Criteria: - 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 |
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
United States | Oklahoma State University | Stillwater | Oklahoma |
Lead Sponsor | Collaborator |
---|---|
Oklahoma State University | Mid America Athletic Training Association |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Up to 6 months | Yes |
Primary | 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. | Up to 6 months | No |
Secondary | 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. | Up to 6 months | No |
Secondary | 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). | Up to 6 months | No |
Secondary | 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. | Up to 6 months | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
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