The Role of Antioxidant Supplementation in Keratoconus Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-01

Study Completion Date

2023-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Keratoconus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo pill

Dietary Sources

Intervention Type COMBINATION_PRODUCT

From dietary sources of vitamins.

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.

Group Type ACTIVE_COMPARATOR

Antioxidants (Vitamins A,C,E) plus GSH

Intervention Type OTHER

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).

Centrum

Intervention Type DIETARY_SUPPLEMENT

Centrum

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.

Group Type ACTIVE_COMPARATOR

Antioxidants (Vitamins A,C,E) plus GSH

Intervention Type OTHER

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).

Placebo plus Centrum

Persons assigned to placebo, who have been on oral RDA supplementation, who would continue to do so throughout the study.

Group Type ACTIVE_COMPARATOR

Placebo

Intervention Type OTHER

Placebo pill

Centrum

Intervention Type DIETARY_SUPPLEMENT

Centrum

Interventions

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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).

Intervention Type OTHER

Placebo

Placebo pill

Intervention Type OTHER

Centrum

Intervention Type DIETARY_SUPPLEMENT

Dietary Sources

From dietary sources of vitamins.

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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.