Supplemental Adjuvants for Intracellular Nutrition and Treatment

Diabetic Macular Edema Clinical Trial

— SAINTS  

Official title:

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT00893724
• Other study ID #: FF0901
• Status: Unknown status
• Phase: N/A
• First received: May 4, 2009
• Last updated: July 19, 2011
• Start date: June 2009
• Est. completion date: September 2011

Study information

• Verified date: July 2011
• Source: Mid-Atlantic Retina Consultations, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 60
• Est. completion date: September 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Clinical Diagnosis of NAMD

• Clinical Diagnosis of DME

Exclusion Criteria:

• Pregnant Women

• Known allergy to any component used in the treatment combinations

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Macular Degeneration
• Macular Edema
• Neovascular Age-related Macular Degeneration
• Wet Macular Degeneration

Intervention

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

Locations

Country	Name	City	State
United States	Mid-Atlantic Retina Consultations, Inc.	Morgantown	West Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Mid-Atlantic Retina Consultations, Inc.	West Virginia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Degree of regression (Optical Coherence Tomography)		Monthly
Primary	Duration of regression (Optical Coherence Tomography)		Monthly
Primary	Visual change (ETDRS)		Monthly
Secondary	Effect on HbA1C		Monthly
Secondary	Effect on Blood pressure		Monthly
Secondary	Effect on serum uric acid		Monthly