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Supplemental Adjuvants for Intracellular Nutrition and Treatment (SAINTS)

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ClinicalTrials.gov Identifier: NCT00893724
Recruitment Status : Unknown
Verified July 2011 by Mid-Atlantic Retina Consultations, Inc..
Recruitment status was:  Active, not recruiting
First Posted : May 6, 2009
Last Update Posted : July 20, 2011
Sponsor:
Collaborator:
West Virginia University
Information provided by:
Mid-Atlantic Retina Consultations, Inc.

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).

Condition or disease Intervention/treatment Phase
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 Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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
Study Start Date : June 2009
Estimated Primary Completion Date : August 2011
Estimated Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Degree of regression (Optical Coherence Tomography) [ Time Frame: Monthly ]
  2. Duration of regression (Optical Coherence Tomography) [ Time Frame: Monthly ]
  3. Visual change (ETDRS) [ Time Frame: Monthly ]

Secondary Outcome Measures :
  1. Effect on HbA1C [ Time Frame: Monthly ]
  2. Effect on Blood pressure [ Time Frame: Monthly ]
  3. Effect on serum uric acid [ Time Frame: Monthly ]


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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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.

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
First Posted: May 6, 2009    Key Record Dates
Last Update Posted: July 20, 2011
Last Verified: July 2011

Keywords provided by Mid-Atlantic Retina Consultations, Inc.:
DME
NAMD
Oxidative damage
Nutritional supplements/vitamins
DNA repair
NAMD/wet AMD

Additional relevant MeSH terms:
Macular Degeneration
Macular Edema
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Vitamins
Ascorbic Acid
Tocopherols
Vitamin E
Tocotrienols
alpha-Tocopherol
Coenzyme Q10
Niacinamide
Niacin
Nicotinic Acids
Acetylcysteine
N-monoacetylcystine
Ubiquinone
Minocycline
Micronutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Anti-Bacterial Agents
Anti-Infective Agents
Antiviral Agents
Expectorants