NCT00893724

Supplemental Adjuvants for Intracellular Nutrition and Treatment

The Effect of Supplemental Adjuvants for Intracellular Nutrition and Treatment on Diabetic Macular Edema and Neovascular Age-Related Macular Degeneration

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Mid-Atlantic Retina Consultations, Inc. · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Neovascular Age-related Macular Degeneration
• Diabetic Macular Edema

Interventions

Type	Name	Description
DRUG	Neutral pills with no medicinal effect	Neutral pills with no medicinal effect
DIETARY_SUPPLEMENT	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
DRUG	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

Timeline

• Start date: 2009-06-01
• Primary completion: 2011-08-01
• Completion: 2011-09-01
• First posted: 2009-05-06
• Last updated: 2011-07-20

Locations

1 site across 1 country: United States