Dietary Riboflavin (Vitamin B-2) and Cornea Cross-Linking
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ClinicalTrials.gov Identifier: NCT03095235 |
Recruitment Status : Unknown
Verified April 2019 by John Jarstad, M.D., University of Missouri-Columbia.
Recruitment status was: Recruiting
First Posted : March 29, 2017
Last Update Posted : April 22, 2019
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Condition or disease | Intervention/treatment | Phase |
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Keratoconus Cornea Ectasia | Dietary Supplement: Dietary riboflavin | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 24 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Dietary Riboflavin (Vitamin B-2) and Cornea Cross-Linking |
Actual Study Start Date : | May 1, 2017 |
Estimated Primary Completion Date : | January 2022 |
Estimated Study Completion Date : | January 2022 |

Arm | Intervention/treatment |
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Experimental: Treatment with riboflavin
Patients will take 400 mg dietary riboflavin per day and go outside without sunglasses for 15 minutes per day to evaluate the effects of riboflavin B2 and natural UV light from sun exposure on cornea cross linking and stabilization of ectatic disease.
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Dietary Supplement: Dietary riboflavin
Dietary riboflavin is vitamin B2. It has been shown to be safe in children in the treatment of migraines at doses of 400 mg per day. There are no known documented side effects
Other Name: Vitamin B2 |
- Degree of corneal steepening [ Time Frame: 6 months ]Keratometry measures the degree of astigmatism of the cornea to monitor the degree of cornea steepening
- Best corrected visual acuity [ Time Frame: 6 months ]Measures the best vision the patient is able to see at that time

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Ages Eligible for Study: | 12 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- patients identified as having keratoconus or post refractive cornea ectasia with astigmatism of 1.5 Diopters or greater.
Exclusion Criteria:
- Known sensitivity to riboflavin, sunlight.
- patients on medications with side effects of increased sunlight sensitivity should discuss participation with their prescribing provider prior to participation

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03095235
Contact: John S Jarstad, MD | (573) 884-2876 | jarstadj@health.missouri.edu | |
Contact: Van D Nguyen, MD | (573) 884-2876 | nguyenvd@health.missouri.edu |
United States, Missouri | |
University of Missouri | Recruiting |
Columbia, Missouri, United States, 65212 | |
Contact: Lindsey M McDaniel, MD 573-882-1506 | |
Contact: John Jarstad, MD 5738821506 |
Principal Investigator: | John S Jarstad, MD | University of Missouri- Department of Ophthalmology |
Responsible Party: | John Jarstad, M.D., Associate Professor, Department of Ophthalmology, University of Missouri-Columbia |
ClinicalTrials.gov Identifier: | NCT03095235 |
Other Study ID Numbers: |
2006390 |
First Posted: | March 29, 2017 Key Record Dates |
Last Update Posted: | April 22, 2019 |
Last Verified: | April 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
keratoconus cornea ectasia |
Keratoconus Corneal Diseases Dilatation, Pathologic Eye Diseases Pathological Conditions, Anatomical Riboflavin |
Vitamins Micronutrients Physiological Effects of Drugs Vitamin B Complex Photosensitizing Agents Dermatologic Agents |