The Role of Antioxidant Supplementation in Keratoconus Patients

NCT02827747 — Phase 2, Withdrawn, University of Miami

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The Role of Antioxidants in Keratoconus Patients-A Randomized Controlled Trial of Oral Supplementation of Glutathione, Vitamin A, Vitamin C and Vitamin E

Registry	NCT02827747
Status	Withdrawn - Not enough participant interest.
Phase	Phase 2
Study type	Interventional; randomized, parallel, masking: double, prevention
Sponsor	University of Miami (Other); collaborators: Fight for Sight
Conditions	Keratoconus
Interventions	Antioxidants (Vitamins A,C,E) plus GSH, Placebo, Centrum, Dietary Sources (Other, dietary supplement, combination product)
Dates	start 2021-08-01 (estimated), primary completion 2022-07-01 (estimated), completion 2023-03-01 (estimated), first posted 2016-07-11, last updated 2021-08-16
Locations	1 site in United States

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Placebo with Dietary Sources of Vitamins	Placebo comparator	Other: Placebo; Combination Product: Dietary Sources	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.
Antioxidants(Vitamins A,C,E) plus GSH, plus Centrum	Active comparator	Other: Antioxidants (Vitamins A,C,E) plus GSH; Dietary Supplement: Centrum	Persons assigned to the study medication, and are continuing the take an oral RDA supplementation, in the form of Centrum.
Antioxidants (Vitamins A,C, E) plus GSH	Active comparator	Other: 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.
Placebo plus Centrum	Active comparator	Other: Placebo; Dietary Supplement: Centrum	Persons assigned to placebo, who have been on oral RDA supplementation, who would continue to do so throughout the study.

Antioxidants (Vitamins A,C,E) plus GSH (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 (Other): Placebo pill
Centrum (Dietary supplement): Centrum
Dietary Sources (Combination product): From dietary sources of vitamins.

+Outcome measures

Primary outcomes

Change in Visual Acuity Measured by Snellen Chart [Baseline to 24 months]

Secondary outcomes

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

+Eligibility

Sex: All, ages: 18 Years to 45 Years

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.

+Locations (1)

Facility	City	Country	Status
Bascom Palmer Eye Institute-- Palm Beach Gardens	Palm Beach Gardens, Florida	United States

+Investigators

Ellen Koo, M.D., Principal investigator, University of Miami

My Notes

Public

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