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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05907850
Other study ID # HSC20230413H
Secondary ID
Status Recruiting
Phase Early Phase 1
First received
Last updated
Start date June 23, 2023
Est. completion date December 2024

Study information

Verified date March 2024
Source The University of Texas Health Science Center at San Antonio
Contact Steven Moore, MD
Phone (512) 657-6674
Email mooresb@uthscsa.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this project is to investigate the effects of riboflavin, also known as vitamin B2, on preventing delayed onset muscle soreness (DOMS) in ultramarathon athletes through a randomized placebo-controlled study.


Description:

The riboflavin 100 mg capsules will be self-dosed by the participant, one capsule prior to the long stage of the race followed by a second dose at the end of the long stage. Historically, long-stage finish times have ranged between 8 and 24 hours. The placebo will also be dosed as one capsule on the morning of the long stage, prior to the race start, and one capsule at the end of the long stage.


Recruitment information / eligibility

Status Recruiting
Enrollment 400
Est. completion date December 2024
Est. primary completion date December 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Male or female, aged 18 or over 4. In good general health as evidenced by readiness to participate in an ultramarathon 5. Ability to take oral medication and be willing to adhere to the study regimen 6. For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening. Exclusion Criteria: 1. Unable to read or understand English 2. Under 18 years of age 3. Pregnancy or lactation 4. Known allergic reactions to components of the investigational drugs

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Riboflavin
Commercially available source of riboflavin capsules
Placebo
Placebo capsule compounded to be similar in appearance to the active intervention

Locations

Country Name City State
United States The University of Texas Health Science Center at San Antonio San Antonio Texas

Sponsors (2)

Lead Sponsor Collaborator
Steven Moore Racing the Planet

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Muscle soreness measure for long stage of the ultramarathon Change in muscle soreness at completion of the long stage (80+ kilometers) of the ultramarathon. Muscle soreness the day following long stage completion. Muscle soreness will be measured using a Likert scale rated from 0 to 10 where 0 indicates no soreness and 10 indicates unbearable pain. Baseline to 6 days
Secondary Muscle soreness measure post-race Muscle soreness the day following long stage completion. Muscle soreness the day following long stage completion. Muscle soreness will be measured using a Likert scale rated from 0 to 10 where 0 indicates no soreness and 10 indicates unbearable pain. Day 7
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