NCT00893724

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 4, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 6, 2009

Completed
26 days until next milestone

Study Start

First participant enrolled

June 1, 2009

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

July 20, 2011

Status Verified

July 1, 2011

Enrollment Period

2.2 years

First QC Date

May 4, 2009

Last Update Submit

July 19, 2011

Conditions

Neovascular Age-related Macular DegenerationDiabetic Macular Edema

Keywords

DMENAMDOxidative damageNutritional supplements/vitaminsDNA repairNAMD/wet AMD

Outcome Measures

Primary Outcomes (3)

  • Degree of regression (Optical Coherence Tomography)

    Monthly

  • Duration of regression (Optical Coherence Tomography)

    Monthly

  • Visual change (ETDRS)

    Monthly

Secondary Outcomes (3)

  • Effect on HbA1C

    Monthly

  • Effect on Blood pressure

    Monthly

  • Effect on serum uric acid

    Monthly

Study Arms (3)

P (Placebo)

PLACEBO COMPARATOR
Drug: Neutral pills with no medicinal effect

S (Supplement)

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

SM (Supplement with Minocycline)

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

Interventions

Neutral pills with no medicinal effectDRUG

Neutral pills with no medicinal effect

P (Placebo)
Inosine; Tocopherols, Tocotrienol, CoQ10 combination capsule; Niacinamide SR; Viatmin C; N-acetyl Cysteine; Complete Multivitamin with all mineralsDIETARY_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

S (Supplement)
Inosine; Tocopherol, Tocotrienol, CoQ10 combination capsule; Niacinamide; Vitamin C; N-acetyl Cysteine; Complete Multivitamin with all minerals; MinocyclineDRUG

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

SM (Supplement with Minocycline)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical Diagnosis of NAMD
  • Clinical Diagnosis of DME

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mid-Atlantic Retina Consultations, Inc.

Morgantown, West Virginia, 26505, United States

Location

Related Publications (1)

  • 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.

    PMID: 37702300DERIVED

MeSH Terms

Interventions

InosineTocopherolsTocotrienolsAcetylcysteineNiacinamideAscorbic AcidMinocycline

Intervention Hierarchy (Ancestors)

Purine NucleosidesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosidesVitamin EBenzopyransPyransHeterocyclic Compounds, 1-RingCysteineAmino Acids, SulfurSulfur CompoundsOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and ProteinsNicotinic AcidsAcids, HeterocyclicPyridinesSugar AcidsAcids, AcyclicCarboxylic AcidsHydroxy AcidsCarbohydratesTetracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic Compounds

Study Officials

  • Nabil M Jabbour, MD, FACS

    M.A.R.C.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 4, 2009

First Posted

May 6, 2009

Study Start

June 1, 2009

Primary Completion

August 1, 2011

Study Completion

September 1, 2011

Last Updated

July 20, 2011

Record last verified: 2011-07

Locations

US(1)