Efficacy of Ubiquinone and Combined Antioxidant Therapy in Non-proliferative Diabetic Retinopathy

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

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2014-01-31

Brief Summary

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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.

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Detailed Description

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The investigators are interested in demonstrating the efficacy of Ubiquinone and combined antioxidant therapy in the pharmacological management of diabetic retinopathy since early stages.

Conditions

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Non-proliferative Diabetic Retinopathy Diabetes Mellitus Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Ubiquinone

400mg daily of oral ubiquinone for 24 weeks

Group Type EXPERIMENTAL

Ubiquinone

Intervention Type DRUG

400mg daily of oral ubiquinone for 24 weeks

Combined antioxidant therapy

(1mg copper + 20mg zinc + 180mg vitamin C + 30mg vitamin E + 1mg zeaxanthin + 4mg astaxanthin + 10mg lutein) daily of oral antioxidant combined therapy for 24 weeks

Group Type EXPERIMENTAL

Combined antioxidant therapy

Intervention Type DRUG

(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

Placebo

Placebo. 100mg daily oral intake for 24 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

100 mg of oral placebo with identical appearance, form, size than ubiquinone and antioxidant combined therapy for 24 weeks

Interventions

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Ubiquinone

400mg daily of oral ubiquinone for 24 weeks

Intervention Type 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

Intervention Type DRUG

Placebo

100 mg of oral placebo with identical appearance, form, size than ubiquinone and antioxidant combined therapy for 24 weeks

Intervention Type DRUG

Other Intervention Names

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coenzyme Q10 lutein zeaxanthin astaxanthin vitamin C vitamin E zinc copper Inactive drug

Eligibility Criteria

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Inclusion Criteria

* Patients with type 2 diabetes mellitus
* Patients with non proliferative diabetic retinopathy
* Glycated hemoglobin \< 12.0%
* Signing of informed consent

Exclusion Criteria

* Patients with clinically significant macular edema
* Patients with diabetic retinopathy advanced lesions that have required or require specific treatment (laser, vitrectomy)
* Pretreatment with argon laser or excimer laser Ophthalmology surgery
* Any other associated ocular pathology (glaucoma, cataracts, changing cornea dystrophy, macular degeneration)
* Pregnancy, lactation, inadequate use of contraception
* Antioxidant drug and/or supplements six months previous to enrollment
* Renal and/or hepatic failure
* Age under 30 or over 75 years
* Severe cardiovascular disease (myocardial infarction, stroke, severe peripheral vasculopathy)
* Blood dyscrasias
* Have or have had cancer or other serious illness
* Neurodegenerative process
* Allergy to vitamins

Minimum Eligible Age

30 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes