Vitamin B2 + Sunlight for Near-sightedness
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if riboflavin (Vitamin B2) and daily sunlight can slow the progression of nearsightedness in children. The trial will assess whether different doses of riboflavin combined with outdoor play are more effective than no riboflavin. Children diagnosed with myopia and mild astigmatism may be suitable candidates. Participants will be divided into groups to receive either 400 mg, 200 mg, or no riboflavin while playing outside for 30 minutes daily over six months. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group.
Will I have to stop taking my current medications?
The trial information does not specify whether participants need to stop taking their current medications.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that riboflavin, also known as Vitamin B2, is generally safe for use. The FDA has labeled it as "generally recognized as safe" (GRAS), indicating it is safe to consume in the amounts typically found in foods or supplements.
Studies have not reported any serious side effects. Most reports mention only mild issues, such as a change in urine color, which is harmless and expected. In studies for other conditions, riboflavin did not cause any major problems.
Since this trial is in an early stage, the researchers are primarily focusing on safety. They believe riboflavin is well-tolerated, but further studies will help clarify its safety for this specific use.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the use of riboflavin, or vitamin B2, for managing myopia in children because it offers a novel approach compared to the usual methods like corrective lenses or atropine eye drops. Unlike typical treatments that focus on symptom management, riboflavin might address the progression of myopia by potentially strengthening the eye's connective tissues through its role in energy production and repair processes. Additionally, combining riboflavin with outdoor sunlight exposure could harness natural light's benefits in slowing myopia progression, offering a holistic and non-invasive strategy. This treatment could be particularly appealing due to its simplicity and the added health benefits of increased outdoor activity.
What evidence suggests that riboflavin might be an effective treatment for preventing myopia progression?
Research has shown that riboflavin, or Vitamin B2, might improve eye health when combined with sunlight. Early studies on conditions like keratoconus, where the cornea becomes thin and cone-shaped, suggest that taking riboflavin and spending time in the sun can help prevent further eye problems. In this trial, participants will receive different doses of riboflavin: one group will take 400 mg daily, another group will take 200 mg daily, and a placebo group will receive 0 mg. Specifically, one study found that people who took 400 mg of riboflavin daily and got sun exposure saw their eye condition stabilize or improve. These findings are encouraging for using riboflavin to possibly slow the worsening of nearsightedness (myopia) in children.678910
Who Is on the Research Team?
Mohannad Al-Samarraie, MD
Principal Investigator
Virginia Commonwealth University
Are You a Good Fit for This Trial?
Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either 400 mg, 200 mg, or 0 mg (placebo) of oral riboflavin daily and are encouraged to play outside for 30 minutes each day for 6 months
Follow-up
Participants are monitored for changes in cycloplegic refraction, axial length, uncorrected best visual acuity, and keratometry values
What Are the Treatments Tested in This Trial?
Interventions
- Riboflavin
Riboflavin is already approved in United States, European Union for the following indications:
- Progressive keratoconus
- Corneal ectasia following refractive surgery
- Progressive keratoconus
- Corneal ectasia following refractive surgery
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Missouri-Columbia
Lead Sponsor