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Supplemental Adjuvants for Intracellular Nutrition and Treatment (SAINTS)

Primary Purpose

Neovascular Age-related Macular Degeneration, Diabetic Macular Edema

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Neutral pills with no medicinal effect
Inosine; Tocopherols, Tocotrienol, CoQ10 combination capsule; Niacinamide SR; Viatmin C; N-acetyl Cysteine; Complete Multivitamin with all minerals
Inosine; Tocopherol, Tocotrienol, CoQ10 combination capsule; Niacinamide; Vitamin C; N-acetyl Cysteine; Complete Multivitamin with all minerals; Minocycline
Sponsored by
Mid-Atlantic Retina Consultations, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neovascular Age-related Macular Degeneration focused on measuring DME, NAMD, Oxidative damage, Nutritional supplements/vitamins, DNA repair, NAMD/wet AMD

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Mid-Atlantic Retina Consultations, Inc.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

P (Placebo)

S (Supplement)

SM (Supplement with Minocycline)

Arm Description

Outcomes

Primary Outcome Measures

Degree of regression (Optical Coherence Tomography)
Duration of regression (Optical Coherence Tomography)
Visual change (ETDRS)

Secondary Outcome Measures

Effect on HbA1C
Effect on Blood pressure
Effect on serum uric acid

Full Information

First Posted
May 4, 2009
Last Updated
July 19, 2011
Sponsor
Mid-Atlantic Retina Consultations, Inc.
Collaborators
West Virginia University
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1. Study Identification

Unique Protocol Identification Number
NCT00893724
Brief Title
Supplemental Adjuvants for Intracellular Nutrition and Treatment
Acronym
SAINTS
Official Title
The Effect of Supplemental Adjuvants for Intracellular Nutrition and Treatment on Diabetic Macular Edema and Neovascular Age-Related Macular Degeneration
Study Type
Interventional

2. Study Status

Record Verification Date
July 2011
Overall Recruitment Status
Unknown status
Study Start Date
June 2009 (undefined)
Primary Completion Date
August 2011 (Anticipated)
Study Completion Date
September 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Mid-Atlantic Retina Consultations, Inc.
Collaborators
West Virginia University

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neovascular Age-related Macular Degeneration, Diabetic Macular Edema
Keywords
DME, NAMD, Oxidative damage, Nutritional supplements/vitamins, DNA repair, NAMD/wet AMD

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
P (Placebo)
Arm Type
Placebo Comparator
Arm Title
S (Supplement)
Arm Type
Active Comparator
Arm Title
SM (Supplement with Minocycline)
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Neutral pills with no medicinal effect
Intervention Description
Neutral pills with no medicinal effect
Intervention Type
Dietary Supplement
Intervention Name(s)
Inosine; Tocopherols, Tocotrienol, CoQ10 combination capsule; Niacinamide SR; Viatmin C; N-acetyl Cysteine; Complete Multivitamin with all minerals
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Inosine; Tocopherol, Tocotrienol, CoQ10 combination capsule; Niacinamide; Vitamin C; N-acetyl Cysteine; Complete Multivitamin with all minerals; Minocycline
Intervention Description
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 Measure Information:
Title
Degree of regression (Optical Coherence Tomography)
Time Frame
Monthly
Title
Duration of regression (Optical Coherence Tomography)
Time Frame
Monthly
Title
Visual change (ETDRS)
Time Frame
Monthly
Secondary Outcome Measure Information:
Title
Effect on HbA1C
Time Frame
Monthly
Title
Effect on Blood pressure
Time Frame
Monthly
Title
Effect on serum uric acid
Time Frame
Monthly

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nabil M Jabbour, MD, FACS
Organizational Affiliation
M.A.R.C.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mid-Atlantic Retina Consultations, Inc.
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26505
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Supplemental Adjuvants for Intracellular Nutrition and Treatment

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