Effects of Riboflavin in Mitigating Muscle Soreness in Ultra-marathon Athletes

Steven Moore

Status and phase: Completed; Early Phase 1

Conditions: Muscle Soreness

Treatments: Drug: Riboflavin; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05907850

HSC20230413H

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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150 participants in 2 patient groups, including a placebo group

Riboflavin Group

Active Comparator group

Description:

Riboflavin 100mg will be self administered by participants, one capsules prior to the long stage of the race followed by a second dose at the completion of the long stage.

Treatment:

Drug: Riboflavin

Placebo/Control Group

Placebo Comparator group

Description:

Placebo will be self administered by participants, one capsule prior to the long stage of the race followed by a second dose at the completion of the long stage.

Treatment:

Drug: Placebo