Supplemental Adjuvants for Intracellular Nutrition and Treatment

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Neovascular Age-related Macular Degeneration, Diabetic Macular Edema

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical Diagnosis of NAMD Clinical Diagnosis of DME Exclusion Criteria: Pregnant Women Known allergy to any component used in the treatment combinations
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: P (Placebo)<br> | Drug: Neutral pills with no medicinal effect<br>* Neutral pills with no medicinal effect<br>|
| Active Comparator: S (Supplement)<br> | Dietary Supplement: Inosine; Tocopherols, Tocotrienol, CoQ10 combination capsule; Niacinamide SR; Viatmin C; N-acetyl Cysteine; Complete Multivitamin with all minerals<br>* 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<br>|
| Active Comparator: SM (Supplement with Minocycline)<br> | Drug: Inosine; Tocopherol, Tocotrienol, CoQ10 combination capsule; Niacinamide; Vitamin C; N-acetyl Cysteine; Complete Multivitamin with all minerals; Minocycline<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Degree of regression (Optical Coherence Tomography) |  | Monthly | 
| Duration of regression (Optical Coherence Tomography) |  | Monthly | 
| Visual change (ETDRS) |  | Monthly | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect on HbA1C |  | Monthly | 
| Effect on Blood pressure |  | Monthly | 
| Effect on serum uric acid |  | Monthly | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DME, NAMD, Oxidative damage, Nutritional supplements/vitamins, DNA repair, NAMD/wet AMD