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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 : January 21, 2019
Sponsor:
Collaborator:
Fight for Sight
Information provided by (Responsible Party):
Ellen Koo, University of Miami

Study Description
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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
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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 : June 1, 2019
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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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
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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
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Information from the National Library of Medicine

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


Contacts
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Contact: Chantey Roberts, B.A. 561-515-1534 c.roberts3@med.miami.edu

Locations
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United States, Florida
Bascom Palmer Eye Institute-- Palm Beach Gardens Not yet recruiting
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.         
Sponsors and Collaborators
University of Miami
Fight for Sight
Investigators
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Principal Investigator: Ellen Koo, M.D. University of Miami
More Information
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Responsible Party: Ellen Koo, Assistant Professor of Ophthalmology, University of Miami
ClinicalTrials.gov Identifier: NCT02827747     History of Changes
Other Study ID Numbers: 20150646
First Posted: July 11, 2016    Key Record Dates
Last Update Posted: January 21, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Keratoconus
Corneal Diseases
Eye Diseases
Vitamins
Vitamin E
Vitamin A
Antioxidants
Retinol palmitate
 Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action
Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents