The Role of Antioxidant Supplementation in Keratoconus Patients
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ClinicalTrials.gov Identifier: NCT02827747 |
Recruitment Status :
Not yet recruiting
First Posted : July 11, 2016
Last Update Posted : December 30, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Keratoconus | Other: Antioxidants (Vitamins A,C,E) plus GSH Other: Placebo Dietary Supplement: Centrum Combination Product: Dietary Sources | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 100 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Prevention |
Official Title: | The Role of Antioxidants in Keratoconus Patients-A Randomized Controlled Trial of Oral Supplementation of Glutathione, Vitamin A, Vitamin C and Vitamin E |
Estimated Study Start Date : | August 1, 2021 |
Estimated Primary Completion Date : | July 2022 |
Estimated Study Completion Date : | March 2023 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: Placebo with Dietary Sources of Vitamins
Persons assigned to placebo, who obtain Vitamins A, C, E and Glutathione from dietary sources alone, and have not been on oral RDA supplementation, in the 1 month leading up the time of enrollment and throughout the study period.
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Other: Placebo
Placebo pill Combination Product: Dietary Sources From dietary sources of vitamins. |
Active Comparator: Antioxidants(Vitamins A,C,E) plus GSH, plus Centrum
Persons assigned to the study medication, and are continuing the take an oral RDA supplementation, in the form of Centrum.
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Other: Antioxidants (Vitamins A,C,E) plus GSH
Study medication would contain 500 milligrams of vitamin C, 400 International Units of vitamin E, and 15 milligrams of beta-carotene (the equivalent to 25,000 International Units of vitamin A).The study medication would also contain 1000mg of Glutathione (GSH). Dietary Supplement: Centrum Centrum |
Active Comparator: Antioxidants (Vitamins A,C, E) plus GSH
Persons assigned to the study medication alone, without oral RDA supplementation in the 1 month leading up the time of enrollment and throughout the study period.
|
Other: Antioxidants (Vitamins A,C,E) plus GSH
Study medication would contain 500 milligrams of vitamin C, 400 International Units of vitamin E, and 15 milligrams of beta-carotene (the equivalent to 25,000 International Units of vitamin A).The study medication would also contain 1000mg of Glutathione (GSH). |
Active Comparator: Placebo plus Centrum
Persons assigned to placebo, who have been on oral RDA supplementation, who would continue to do so throughout the study.
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Other: Placebo
Placebo pill Dietary Supplement: Centrum Centrum |
- Change in Visual Acuity Measured by Snellen Chart [ Time Frame: Baseline to 24 months ]
- Change in cornea thickness as measured by video keratography [ Time Frame: Baseline to 24 months ]
- Plasma level of Vitamin A [ Time Frame: Baseline to 24 months ]Blood draws to look at plasma level of Vitamin A
- Plasma level of Vitamin C [ Time Frame: Baseline to 24 months ]Blood draws to look at plasma level of Vitamin C
- Plasma level of Vitamin E [ Time Frame: Baseline to 24 months ]Blood draws to look at plasma level of Vitamin E
- Plasma level of Glutathione (GSH) [ Time Frame: Baseline to 24 months ]Blood draws to look at plasma level of GSH

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Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Participants would be without illness or condition that could make follow-up, or compliance with study medication difficult.
- Participants may have a prior diagnosis of Keratoconus, or may be diagnosed at the initial visit.
- Participants should not have an eye diagnosis, other than Keratoconus, that could adversely influence the visual acuity.
- These participants must not have had prior surgical procedure to treat Keratoconus, including collagen cross-linking, Intacs ring segments, or corneal transplantation.
Exclusion Criteria:
- would exclude smokers and former-smokers.

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): NCT02827747
Contact: Chantey Roberts, B.A. | 561-515-1534 | c.roberts3@med.miami.edu |
United States, Florida | |
Bascom Palmer Eye Institute-- Palm Beach Gardens | |
Palm Beach Gardens, Florida, United States, 33418 | |
Contact: Chantey Roberts, B.A. 561-515-1534 c.roberts3@med.miami.edu | |
Principal Investigator: Ellen Koo, M.D. | |
Sub-Investigator: Richard Forster, M.D. |
Principal Investigator: | Ellen Koo, M.D. | University of Miami |
Responsible Party: | Ellen Koo, Assistant Professor of Ophthalmology, University of Miami |
ClinicalTrials.gov Identifier: | NCT02827747 |
Other Study ID Numbers: |
20150646 |
First Posted: | July 11, 2016 Key Record Dates |
Last Update Posted: | December 30, 2020 |
Last Verified: | December 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Keratoconus progression Vitamins and keratoconus Vitamin supplementation |
Keratoconus Corneal Diseases Eye Diseases Vitamin A Antioxidants Vitamins |
Micronutrients Nutrients Growth Substances Physiological Effects of Drugs Molecular Mechanisms of Pharmacological Action Protective Agents |