Overview

This trial is active, not recruiting.

Conditions neovascular age-related macular degeneration, diabetic macular edema
Treatments neutral pills with no medicinal effect, inosine; tocopherols, tocotrienol, coq10 combination capsule; niacinamide sr; viatmin c; n-acetyl cysteine; complete multivitamin with all minerals, inosine; tocopherol, tocotrienol, coq10 combination capsule; niacinamide; vitamin c; n-acetyl cysteine; complete multivitamin with all minerals; minocycline
Sponsor Mid-Atlantic Retina Consultations, Inc.
Collaborator West Virginia University
Start date June 2009
End date August 2011
Trial size 60 participants
Trial identifier NCT00893724, FF0901

Summary

Nutritional supplements have an augmentative effect on the outcomes of standard treatment of diabetic macular edema (DME) and Neovascular Age-Related Macular Degeneration (NAMD).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose treatment
Arm
(Placebo Comparator)
neutral pills with no medicinal effect
Neutral pills with no medicinal effect
(Active Comparator)
inosine; tocopherols, tocotrienol, coq10 combination capsule; niacinamide sr; viatmin c; n-acetyl cysteine; complete multivitamin with all minerals
Inosine [SR] - 1[500mg] tablet bid Tocopherols [200IU], Tocotrienol [10mg], CoQ10 [50mg] - combination capsule bid Sustained Release Niacinamide - 1 [750mg] tablet bid Vitamin C - 1 [1000mg] sustained release tablet bid N-acetyl Cysteine - 1 [600mg] sustained release tablet qd Complete Multivitamin with all minerals - 1 tablet (sustained release) bid
(Active Comparator)
inosine; tocopherol, tocotrienol, coq10 combination capsule; niacinamide; vitamin c; n-acetyl cysteine; complete multivitamin with all minerals; minocycline
Inosine [SR] - 1 [500mg] tablet bid Tocopherol [200IU], Tocotrienol [10mg], CoQ10 [50mg] combination capsule bid Sustained Release Niacinamide 1 [750mg] tablet bid Vitamin C 1 [1000mg] sustained release tablet bid N-acetyl Cysteine 1 [600mg] sustained release tablet qd Complete Multivitamin with all minerals - 1 tablet (sustained release) bid Minocycline 1 [50mg] tablet qd

Primary Outcomes

Measure
Degree of regression (Optical Coherence Tomography)
time frame: Monthly
Duration of regression (Optical Coherence Tomography)
time frame: Monthly
Visual change (ETDRS)
time frame: Monthly

Secondary Outcomes

Measure
Effect on HbA1C
time frame: Monthly
Effect on Blood pressure
time frame: Monthly
Effect on serum uric acid
time frame: Monthly

Eligibility Criteria

Male or female participants of any age.

Inclusion Criteria: - Clinical Diagnosis of NAMD - Clinical Diagnosis of DME Exclusion Criteria: - Pregnant Women - Known allergy to any component used in the treatment combinations

Additional Information

Official title The Effect of Supplemental Adjuvants for Intracellular Nutrition and Treatment on Diabetic Macular Edema and Neovascular Age-Related Macular Degeneration
Principal investigator Nabil M Jabbour, MD, FACS
Description It has been shown that in chronic diseases, oxidative stress results from Nitric acid reacting with oxygen to form toxins that damage both somatic and mitochondrial DNA. The potential for protecting the DNA and promoting repair by using nutritional supplements will be tested by augmenting standard treatments for DME and NAMD with such supplements. The patients will be randomized to treatment group and placebo group and followed up for a year in a double masked fashion. Anatomic and visual outcomes, as well as side effects will be assessed and analyzed. If the results are promising, this pilot study can be used to design alternative (cheaper, better and longer lasting) treatments for DME, NAMD and perhaps other chronic illnesses.
Trial information was received from ClinicalTrials.gov and was last updated in July 2011.
Information provided to ClinicalTrials.gov by Mid-Atlantic Retina Consultations, Inc..