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| Sponsored by: |
Centre de Recherche en Nutrition Humaine Rhone-Alpe |
|---|---|
| Information provided by: | Centre de Recherche en Nutrition Humaine Rhone-Alpe |
| ClinicalTrials.gov Identifier: | NCT00800995 |
Purpose
INTRODUCTION:
Acting directly on the anti-radical enzyme chain, the superoxide dismutase (SOD), a major enzyme of the anti-oxidant system, provides an alternative of the antioxidants treatment in ARMD. Its synthesis depends on the cellular oxygenated reactive species, and leads to the conversion of the superoxide ion (O2-) into hydrogen peroxide (H2O2). This compound is the cell watch guard continuously regulating a free radicals' detoxifying chain. Subsequently, by increasing the production of H2O2, the administration of SOD can trigger endogenous/internal antioxidant mechanisms.
Oral administration of SOD is possible in its galenic form, Glisodine. The purpose of this study was to evaluate the protective effect of SOD on the bilateralization of the disease.
| Condition | Intervention | Phase |
|---|---|---|
|
Age Related Macular Degeneration |
Dietary Supplement: SOD Dietary Supplement: Sham |
Phase III |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | SOD as Antioxidant Treatment OF ARMD |
| Enrollment: | 46 |
| Study Start Date: | September 2005 |
| Study Completion Date: | June 2008 |
| Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Control: Sham Comparator | Dietary Supplement: Sham |
| SOD: Experimental | Dietary Supplement: SOD |
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations More Information
| Responsible Party: | CHU Grenoble ( Pr Romanet ) |
| Study ID Numbers: | CHUG-0501 |
| Study First Received: | December 2, 2008 |
| Last Updated: | December 2, 2008 |
| ClinicalTrials.gov Identifier: | NCT00800995 |
| Health Authority: | France: Afssaps - French Health Products Safety Agency |
|
ARMD SOD |
|
Eye Diseases Retinal Degeneration Macular Degeneration Retinal Diseases Retinal degeneration |
