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

No results posted yet for this study

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

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

Placebo

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

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02062034 on ClinicalTrials.gov