Supplemental Adjuvants for Intracellular Nutrition and Treatment (SAINTS)

Mid-Atlantic Retina Consultations, Inc.

Status: Unknown

Conditions: Diabetic Macular Edema; Neovascular Age-related Macular Degeneration

Treatments: Drug: Neutral pills with no medicinal effect; Drug: Inosine; Tocopherol, Tocotrienol, CoQ10 combination capsule; Niacinamide; Vitamin C; N-acetyl Cysteine; Complete Multivitamin with all minerals; Minocycline; Dietary Supplement: Inosine; Tocopherols, Tocotrienol, CoQ10 combination capsule; Niacinamide SR; Viatmin C; N-acetyl Cysteine; Complete Multivitamin with all minerals

Study type: Interventional

Funder types: Other

Identifiers

NCT00893724

FF0901

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical Diagnosis of NAMD
• Clinical Diagnosis of DME

Exclusion criteria

• Pregnant Women
• Known allergy to any component used in the treatment combinations

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 3 patient groups, including a placebo group

P (Placebo)

Placebo Comparator group

Treatment:

Drug: Neutral pills with no medicinal effect

S (Supplement)

Active Comparator group

Treatment:

Dietary Supplement: Inosine; Tocopherols, Tocotrienol, CoQ10 combination capsule; Niacinamide SR; Viatmin C; N-acetyl Cysteine; Complete Multivitamin with all minerals

SM (Supplement with Minocycline)

Active Comparator group

Treatment:

Drug: Inosine; Tocopherol, Tocotrienol, CoQ10 combination capsule; Niacinamide; Vitamin C; N-acetyl Cysteine; Complete Multivitamin with all minerals; Minocycline