The Role of Antioxidant Supplementation in Keratoconus Patients

• ClinicalTrials.gov Identifier: NCT02827747
• Recruitment Status: Withdrawn
• First Posted: July 11, 2016
• Last Update Posted: August 16, 2021
• Sponsor: University of Miami
• Collaborator: Fight for Sight
• Information provided by (Responsible Party): Ellen Koo, University of Miami

Study Description

Brief Summary:

Keratoconus is the most common primary cornea ectasia, where the cornea undergoes structural changes, leading to loss of tissue integrity and vision loss. The prevalence of Keratoconus is 1:2000 in the general population. Oxidative stress has been thought to have a major effect in the disease pathogenesis of Keratoconus. In vitro studies have shown increase in metabolites related to oxidative stress in Keratoconus disease, and that Keratoconus cells undergo increased oxidative stress and tissue damage. Animal models have shown a therapeutic effect of Vitamin C (ascorbate) in corneal wound healing. Glutathione and Vitamins A, C, and E are important antioxidants in the human body. To this date, the role of systemic antioxidant supplementation in Keratoconus patients has yet to be studied. In addition, it has yet to be established as to whether there is a correlation between serum antioxidant levels, and the severity of disease in the Keratoconus patient. The investigators propose to investigate the plasma levels of antioxidants in relation to disease severity. The investigators will also investigate the role of antioxidant supplementation-consisting of parenteral Glutathione (GSH), and Vitamins A, C and E-in delaying the disease progression in Keratoconus.

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 0 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

Arms and Interventions

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.	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.	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.	Other: Placebo; Placebo pill; Dietary Supplement: Centrum; Centrum

Outcome Measures

Primary Outcome Measures :

1. Change in Visual Acuity Measured by Snellen Chart [ Time Frame: Baseline to 24 months ]

Secondary Outcome Measures :

1. Change in cornea thickness as measured by video keratography [ Time Frame: Baseline to 24 months ]
2. Plasma level of Vitamin A [ Time Frame: Baseline to 24 months ]
   Blood draws to look at plasma level of Vitamin A
3. Plasma level of Vitamin C [ Time Frame: Baseline to 24 months ]
   Blood draws to look at plasma level of Vitamin C
4. Plasma level of Vitamin E [ Time Frame: Baseline to 24 months ]
   Blood draws to look at plasma level of Vitamin E
5. Plasma level of Glutathione (GSH) [ Time Frame: Baseline to 24 months ]
   Blood draws to look at plasma level of GSH

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 45 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

United States, Florida

Bascom Palmer Eye Institute-- Palm Beach Gardens

Palm Beach Gardens, Florida, United States, 33418

Sponsors and Collaborators

University of Miami

Fight for Sight

Investigators

• Principal Investigator: Ellen Koo, M.D.; University of Miami

More Information

• 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
• Last Update Posted: August 16, 2021
• Last Verified: August 2021

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

Keywords provided by Ellen Koo, University of Miami:

Keratoconus progression; Vitamins and keratoconus; Vitamin supplementation

Additional relevant MeSH terms:

Keratoconus; Corneal Diseases; Eye Diseases; Vitamin A; Antioxidants; Vitamins; Micronutrients; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents