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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00893724

Acronym

SAINTS

Enrollment

Registered

2009-05-06

Start date

2009-06-30

Completion date

2011-09-30

Last updated

2011-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Macular Edema, Neovascular Age-related Macular Degeneration

Keywords

DME, NAMD, Oxidative damage, Nutritional supplements/vitamins, DNA repair, NAMD/wet AMD

Brief 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.

Interventions

DRUGNeutral pills with no medicinal effect

Neutral pills with no medicinal effect

DIETARY_SUPPLEMENTInosine; 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

DRUGInosine; 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
Effect on HbA1C	Monthly
Effect on Blood pressure	Monthly
Effect on serum uric acid	Monthly

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026