Efficacy of Ubiquinone and Combined Antioxidant Therapy in Non-proliferative Diabetic Retinopathy
NCT02062034 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 61
Last updated 2014-02-13
Summary
The purpose of this study is to evaluate the efficacy of ubiquinone and combined antioxidant therapy on progression, clinical regression, oxidative stress markers and mitochondrial dysfunction in non-proliferative diabetic retinopathy.
Conditions
- Non-proliferative Diabetic Retinopathy
- Diabetes Mellitus Type 2
Interventions
- DRUG
-
Ubiquinone
400mg daily of oral ubiquinone for 24 weeks
- DRUG
-
Combined antioxidant therapy
(1 mg copper, 20 mg zinc, 180 mg vitamin C, 30 mg vitamin E, 1 mg zeaxanthin, 4 mg astaxanthin, 10 mg lutein) daily of oral, all of them in one Tablet for 24 weeks
- DRUG
-
100 mg of oral placebo with identical appearance, form, size than ubiquinone and antioxidant combined therapy for 24 weeks
Sponsors & Collaborators
-
Instituto Mexicano del Seguro Social
collaborator OTHER_GOV -
University of Guadalajara
lead OTHER
Principal Investigators
-
Alejandra G. Miranda-Díaz, PhD · University of Guadalajara
-
José A. Castellanos-González, M.Sc. · University of Guadalajara
-
Adolfo D. Rodriguez-Carrizalez, M.Sc. · University of Guadalajara
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 30 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2011-02-28
- Primary Completion
- 2013-11-30
- Completion
- 2014-01-31
Countries
- Mexico
Study Locations
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