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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
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
All Individual Drugs Already Approved

Summary

This trial aims to prevent children from becoming more near-sighted by giving them a vitamin and encouraging outdoor play in sunlight. The combination of the vitamin and UV light may help stop the eye from growing too long, which causes near-sightedness.

Eligible Conditions
  • Refractive Errors
  • Myopia

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

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

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

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
377 Previous Clinical Trials
628,589 Total Patients Enrolled
Mohannad Al-Samarraie, MDPrincipal InvestigatorVirginia Commonwealth University

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
~45 spots leftby Oct 2029
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