Supplemental Adjuvants for Intracellular Nutrition and Treatment

NCT ID: NCT00893724

Last Updated: 2011-07-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2011-09-30

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.

Conditions

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Neovascular Age-related Macular Degeneration Diabetic Macular Edema

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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P (Placebo)

Group Type PLACEBO_COMPARATOR

Neutral pills with no medicinal effect

Intervention Type DRUG

Neutral pills with no medicinal effect

S (Supplement)

Group Type ACTIVE_COMPARATOR

Inosine; Tocopherols, Tocotrienol, CoQ10 combination capsule; Niacinamide SR; Viatmin C; N-acetyl Cysteine; Complete Multivitamin with all minerals

Intervention Type DIETARY_SUPPLEMENT

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

SM (Supplement with Minocycline)

Group Type ACTIVE_COMPARATOR

Inosine; Tocopherol, Tocotrienol, CoQ10 combination capsule; Niacinamide; Vitamin C; N-acetyl Cysteine; Complete Multivitamin with all minerals; Minocycline

Intervention Type DRUG

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

Interventions

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Neutral pills with no medicinal effect

Neutral pills with no medicinal effect

Intervention Type DRUG

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

Intervention Type DIETARY_SUPPLEMENT

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

Intervention Type DRUG

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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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West Virginia University

OTHER

Sponsor Role collaborator

Mid-Atlantic Retina Consultations, Inc.

OTHER

Sponsor Role lead

Responsible Party

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Mid-Atlantic Retina Consultations, Inc.

Principal Investigators

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Nabil M Jabbour, MD, FACS

Role: PRINCIPAL_INVESTIGATOR

M.A.R.C.

Locations

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Mid-Atlantic Retina Consultations, Inc.

Morgantown, West Virginia, United States

Site Status

Countries

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United States

References

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Evans JR, Lawrenson JG. Antioxidant vitamin and mineral supplements for slowing the progression of age-related macular degeneration. Cochrane Database Syst Rev. 2023 Sep 13;9(9):CD000254. doi: 10.1002/14651858.CD000254.pub5.

Reference Type DERIVED
PMID: 37702300 (View on PubMed)

Other Identifiers

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FF0901

Identifier Type: -

Identifier Source: org_study_id

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