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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

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

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
376 Previous Clinical Trials
628,561 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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