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Vitamin

Oral Riboflavin for Refractive Errors

Phase 2
Waitlist Available
Led By Mohannad Al-Samarraie, MD
Research Sponsored by University of Missouri-Columbia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Healthy children ages 6-12 years old with myopia more than 0.50 D and astigmatism no more than 1.5 D.
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights

Study Summary

This trial will test whether riboflavin and time outdoors can prevent near-sightedness in children.

Eligible Conditions
  • Refractive Errors
  • Myopia

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
Children between the ages of 6 and 12 who have nearsightedness (need glasses to see far away) greater than 0.50 D and astigmatism (blurred vision due to an irregularly shaped cornea) no more than 1.5 D.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in cycloplegic refraction
Secondary outcome measures
Change in axial length
Change in keratometry values
Change in uncorrected best visual acuity

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: 400 mg Riboflavin (oral)Experimental Treatment1 Intervention
These patients (approximately 1/3rd of all patients enrolled in the study) will be given 400 mg oral riboflavin each day for 6 months and be encouraged to play outside for 30 minutes a day every day.
Group II: 200 mg Riboflavin (oral)Experimental Treatment1 Intervention
These patients (approximately 1/3rd of all patients enrolled in the study) will be given 200 mg oral riboflavin each day for 6 months and be encouraged to play outside for 30 minutes a day every day.
Group III: 0 mg Riboflavin (oral)Placebo Group1 Intervention
These patients (approximately 1/3rd of all patients enrolled in the study) will be given 0 mg oral riboflavin (placebo) each day for 6 months and be encouraged to play outside for 30 minutes a day every day.

Find a Location

Who is running the clinical trial?

University of Missouri-ColumbiaLead Sponsor
360 Previous Clinical Trials
627,864 Total Patients Enrolled
Mohannad Al-Samarraie, MDPrincipal InvestigatorUniversity of Missouri-Columbia

Media Library

Refractive Errors Research Study Groups: 400 mg Riboflavin (oral), 0 mg Riboflavin (oral), 200 mg Riboflavin (oral)
Refractive Errors Clinical Trial 2023: Riboflavin Highlights & Side Effects. Trial Name: NCT03552016 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What medical concerns can Oral Riboflavin ameliorate?

"Oral Riboflavin is traditionally employed to address dietary or nutritional issues, and can be used therapeutically for vitamin deficiency syndromes, joint aches and pains, or as a supplement."

Answered by AI

What is the aggregate participant count of this research endeavor?

"Affirmative. Per the information hosted on clinicaltrials.gov, this medical research is actively recruiting participants. It was first posted in October 2018 and last revised April 2021, seeking 100 volunteers across one trial site."

Answered by AI

Has the FDA sanctioned Oral Riboflavin as a viable medical treatment?

"Our team has rated the safety of Oral Riboflavin at a 2. This is based on it being in Phase 2, where clinical data supports its safety but no studies have validated efficacy yet."

Answered by AI

Has Oral Riboflavin been evaluated in prior research endeavors?

"Presently, there are 17 investigations into the effects of Oral Riboflavin with 8 research projects in Phase 3. Most studies for this drug take place in San Francisco but 44 other medical sites across the globe have also activated trials."

Answered by AI

Are additional test subjects being accepted for this research endeavor?

"Yes, the information hosted by clinicaltrials.gov validates that this study is proactively enrolling participants. This trial was first submitted on October 10th 2018 and has since been revised to reflect new data as of April 16 2021. The research team needs 100 individuals from a single medical centre for participation in the experiment."

Answered by AI

Is the recruitment for this trial restricted to individuals of a certain age?

"According to the outlined criteria for this medical trial, only participants aged 6-12 are able to take part."

Answered by AI

Is it feasible for me to join this research endeavor?

"To be eligible to partake in this research, potential participants must have refractive errors and fall between the age range of 6-12 years. A maximum of 100 patients are being accepted into this clinical trial."

Answered by AI
~16 spots leftby Mar 2025