Vitamin B2 + Sunlight for Near-sightedness

Not currently recruiting at 1 trial location

Overseen By Ryan N Mercer, MD

Age: < 18

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Missouri-Columbia

Disqualifiers: Allergy to riboflavin, Premature birth, Developmental delay, Major systemic health problems, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

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. ^{1 2 3 4 5}

Why 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. ^{6 7 8 9 10}

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

Caretakers who choose to enroll their child in the study must agree to participate in the study on their own will after knowledge of potential alternatives (spectacle correction, orthokeratology, atropine eye drops, etc.) are explained to the patient's caretaker.

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.

Exclusion Criteria

Significant anisometropia more than 1.5 Diopters

Birth history of premature birth

You are allergic to riboflavin.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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

6 months

Follow-up

Participants are monitored for changes in cycloplegic refraction, axial length, uncorrected best visual acuity, and keratometry values

3 years

What Are the Treatments Tested in This Trial?

Interventions

• Riboflavin

How Is the Trial Designed?

Group I: 400 mg Riboflavin (oral) Experimental Treatment 1 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 Treatment 1 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 Group 1 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.

Riboflavin is already approved in United States, European Union for the following indications:

Approved in United States as Riboflavin ophthalmic solution for:

• Progressive keratoconus
• Corneal ectasia following refractive surgery

Approved in European Union as Riboflavin ophthalmic solution for:

• Progressive keratoconus
• Corneal ectasia following refractive surgery

Who Is Running the Clinical Trial?

University of Missouri-Columbia

Lead Sponsor

Trials

387

Recruited

629,000+

Published Research Related to This Trial

A study involving 100 eyes from 61 patients with progressive keratoconus found that both 0.1% riboflavin solutions used in corneal collagen crosslinking (CXL) were equally safe and effective, with no significant differences in visual and corneal measurements after 12 months.

No serious complications occurred in either group during or after the procedure, indicating that both riboflavin solutions can be safely used for treating keratoconus.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Prospective, Comparative, Clinical Study to Evaluate the Safety and Efficacy of Two Different 0.1% Riboflavin Solutions Used in Collagen Crosslinking Treatment for Patients with Keratoconus. Brar, S., Ganesh, S., Reddy, SS., et al.[2022]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8479745/

emitting glasses and riboflavin drops for corneal ectasia: a ...

Based on our 6-month results, daily treatment of progressive corneal ectasia with KeraVio can halt disease progression without any safety concerns.

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT03095235?term=AREA%5BBasicSearch%5D(RIBOFLAVIN)&rank=4

Dietary Riboflavin (Vitamin B-2) and Cornea Cross-Linking

No adverse effects have ever been reported with high-dose dietary riboflavin supplements. The results of this preliminary trial are remarkable. During follow-up ...

3.

scielo.br

scielo.br/j/rbof/a/y45vx6sfPqFkTq9cWgBJQ3x/?format=pdf&lang=en

ORIGINAL ARTICLE

Patients were instructed to take 400 mg/day of oral riboflavin and to sunbathe for 30 minutes daily, in addition to avoiding eye rubbing.

4.

ctv.veeva.com

ctv.veeva.com/study/dietary-riboflavin-vitamin-b-2-and-cornea-cross-linking

Dietary Riboflavin (Vitamin B-2) and Cornea Cross-Linking

These patients reported no adverse effects and preliminary results showed corneal stabilization and/or corneal flattening in all 7 patients It ...

5.

rbojournal.org

rbojournal.org/wp-content/plugins/xml-to-html/include/lens/index.php?xml=0034-7280-rbof-84-e0036.xml&lang=en

Corneal collagen cross-linking by sun exposure and high ...

Oral riboflavin treatment combined with sun exposure appears to be effective in stabilizing the progression of keratoconus. INTRODUCTION.

6.

fishersci.com

fishersci.com/store/msds?partNumber=AC132351000&productDescription=RIBOFLAVIN+98%25+100GRRIBOFLAVI&vendorId=VN00032119&countryCode=US&language=en

SAFETY DATA SHEET

Physical State. Solid. Appearance. Yellow-orange. Odor. Odorless. Odor Threshold. No information available. pH. 5.5-7.2 0.07g/l water (20°C).

7.

sigmaaldrich.com

sigmaaldrich.com/US/en/sds/SIGMA/R4500?srsltid=AfmBOoqgpIki8HsZUAsGc5OhfLoaoMYcpeUWJd_zOSgKUbzNvpnSSkJj

SAFETY DATA SHEET

Rinse skin with water/ shower. In case of eye contact : After eye contact: rinse out with plenty of water. Remove contact lenses.

8.

isotope.com

isotope.com/product/attachment/CNLM-8851-PK/SDS%20-%20CNLM-8851_V.3.0_US%20-%20English%20US.pdf

VITAMIN B2 (RIBOFLAVIN) (13C4, 99%; 15N2, 98%) ...

Personal protective equipment: Gloves. Protective clothing. Protective goggles. Self-contained breathing apparatus. Eye protection: Wear safety glasses with ...

9.

medkoo.com

medkoo.com/uploads/product/Riboflavin/safety/SDS-Riboflavin.pdf

safety data sheet (sds)

Riboflavin, Vitamin B2, Vitamin G; Lactoflavin. Formula: C17H20N4O6 ... Serious eye damage/eye irritation: No data available. Respiratory or skin ...

10.

accessdata.fda.gov

accessdata.fda.gov/drugsatfda_docs/nda/2016/203324Orig1s000ClinPharmR.pdf

203324Orig1s000 - accessdata.fda.gov

Riboflavin (Vitamin B2) is an ingredient categorized by FDA to be generally recognized as safe. (GRAS). There were no pharmacokinetic studies conducted to ...