Supplemental Adjuvants for Intracellular Nutrition and Treatment - Full Text View

Sponsor:	Mid-Atlantic Retina Consultations, Inc.
Collaborator:	West Virginia University
Information provided by:	Mid-Atlantic Retina Consultations, Inc.
ClinicalTrials.gov Identifier:	NCT00893724

Purpose

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

Condition	Intervention
Neovascular Age-related Macular Degeneration Diabetic Macular Edema	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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Official Title:	The Effect of Supplemental Adjuvants for Intracellular Nutrition and Treatment on Diabetic Macular Edema and Neovascular Age-Related Macular Degeneration

Resource links provided by NLM:

Genetics Home Reference related topics: age-related macular degeneration X-linked juvenile retinoschisis

MedlinePlus related topics: Dietary Supplements Edema Macular Degeneration Minerals Vitamin C Vitamin E

Drug Information available for: Ascorbic acid Cysteine Inosine Niacin Minocycline Minocycline hydrochloride Niacinamide Coenzyme Q10 Acetylcysteine Vitamin E Tocopherols Tocotrienol Cysteine hydrochloride

U.S. FDA Resources

Further study details as provided by Mid-Atlantic Retina Consultations, Inc.:

Primary Outcome Measures:

Degree of regression (Optical Coherence Tomography) [ Time Frame: Monthly ] [ Designated as safety issue: No ]
Duration of regression (Optical Coherence Tomography) [ Time Frame: Monthly ] [ Designated as safety issue: No ]
Visual change (ETDRS) [ Time Frame: Monthly ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Effect on HbA1C [ Time Frame: Monthly ] [ Designated as safety issue: No ]
Effect on Blood pressure [ Time Frame: Monthly ] [ Designated as safety issue: No ]
Effect on serum uric acid [ Time Frame: Monthly ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	June 2009
Estimated Study Completion Date:	September 2011
Estimated Primary Completion Date:	August 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: P (Placebo)	Drug: Neutral pills with no medicinal effect Neutral pills with no medicinal effect
Active Comparator: S (Supplement)	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
Active Comparator: SM (Supplement with Minocycline)	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

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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Clinical Diagnosis of NAMD
Clinical Diagnosis of DME

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00893724

Locations

United States, West Virginia
Mid-Atlantic Retina Consultations, Inc.
Morgantown, West Virginia, United States, 26505

Sponsors and Collaborators

Mid-Atlantic Retina Consultations, Inc.

West Virginia University

Investigators

Principal Investigator:

Nabil M Jabbour, MD, FACS

M.A.R.C.

More Information

No publications provided

Responsible Party:	Nabil M. Jabbour, MD, FACS/ Principal Investigator, Mid-Atlantic Retina Consultations, Inc.
ClinicalTrials.gov Identifier:	NCT00893724 History of Changes
Other Study ID Numbers:	FF0901
Study First Received:	May 4, 2009
Last Updated:	July 19, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Mid-Atlantic Retina Consultations, Inc.:

DME
NAMD
Oxidative damage

Nutritional supplements/vitamins
DNA repair
NAMD/wet AMD

Additional relevant MeSH terms:

Edema
Macular Degeneration
Macular Edema
Wet Macular Degeneration
Signs and Symptoms
Retinal Degeneration
Retinal Diseases
Eye Diseases
Acetylcysteine
Minocycline
N-monoacetylcystine
Ascorbic Acid
Tocopherols
Vitamin E
Tocotrienols

Niacinamide
Niacin
Nicotinic Acids
Vitamins
Coenzyme Q10
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents

ClinicalTrials.gov processed this record on February 09, 2012