NCT00000116

Brief Summary

The purpose of this trial is to determine whether a nutritional supplement in addition to vitamin A will slow the course of retinitis pigmentosa.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
221

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started May 1996

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

May 1, 1996

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

September 23, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 24, 1999

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2002

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2002

Completed
Last Updated

March 8, 2023

Status Verified

February 1, 2023

Enrollment Period

6.3 years

First QC Date

September 23, 1999

Last Update Submit

February 22, 2023

Conditions

Retinitis Pigmentosa

Outcome Measures

Primary Outcomes (1)

  • Change in Humphrey Field Analyzer (HFA) total point score 30-2 program

    Sum of points in Decibels of total points seen in 30-2 program. Higher scores = better vision/larger visual field

    Annual percent change per year at each of 4 years of followup

Secondary Outcomes (3)

  • Change in Humphrey Field Analyzer (HFA) total point score 30 -2 plus 30/60-2 programs combined

    Annual percent change per year at each of four years of followup

  • Change in 30Hz Electroretinogram ( ERG) amplitude

    Annual percent change per year at each of four years of followup

  • Change in Early Treatment of Diabetic Retinopathy(EDTRS) Visual Acuity

    Change in number of letters read per year at each of four years of followup.

Study Arms (2)

Docosahexaenoic acid + Vitamin A

EXPERIMENTAL

Participants randomized to this arm received 1200 mg/d docosahexaenoic acid and 15000 IU/d Vitamin A as retinyl palmitate

Dietary Supplement: Vitamin ADietary Supplement: Docosahexaenoic acid

Control fatty acid + Vitamin A

PLACEBO COMPARATOR

Patients randomized to this arm received 500 mg/d of fatty acid with no docosahexaenoic acid and 15000 IU/ Vitamin A as retinyl palmitate

Dietary Supplement: Vitamin ADietary Supplement: Control fatty acid

Interventions

Vitamin ADIETARY_SUPPLEMENT

15000 IU/d as retinyl palmitate

Control fatty acid + Vitamin ADocosahexaenoic acid + Vitamin A
Docosahexaenoic acidDIETARY_SUPPLEMENT

1200 mg/d

Docosahexaenoic acid + Vitamin A
Control fatty acidDIETARY_SUPPLEMENT
Control fatty acid + Vitamin A

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Ocular Criteria:
  • Retinitis Pigmentosa, typical (non-syndromic) forms Best corrected visual acuity Greater than or equal to (GE )20/100 HFA 30-2 total point score GE 250 dB (decibels) 30 (Hertz) Hz ERG cone amplitude GE 0.68 microvolts
  • Dietary Criteria:
  • Dark fish intake Less than or equal to (LE) five servings per week Dietary omega-3 fatty acid intake LE 0.41 g/d Preformed Vitamin A intake in diet and supplements LE 10,000 IU/d Supplement intake LE 5000 IU/d of Vitamin A and LE 30 IU/d Vitamin E Consumption LE 3 alcoholic beverages per day
  • Medical and other criteria:
  • Body Mass Index Less than (LT )40 and weight GE 5th percentile for age, sex, and height Serum retinol level LE 100 mg/dl and serum retinyl ester levels LE 380 nm/L Serum cholesterol level LT 300 mg/dL and serum triglyceride levels LT 400 mg/dL Agree not to know study capsule content

You may not qualify if:

  • Ocular criteria:
  • No confounding ocular disease
  • Dietary criteria:
  • No intake of cod liver oil or omega-3 capsules
  • Medical and other criteria:
  • Not pregnant or planning to become pregnant No clinically significant abnormal result on Complete Blood Count or serum liver function profile No other disease which might affect absorption or metabolism of DHA or Vitamin A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Berman-Gund Laboratory for the Study of Retinal Degenerations, Harvard Medical School, Massachusetts Eye and Ear Infirmary

Boston, Massachusetts, 02114, United States

Location

Related Publications (4)

  • Berson EL, Rosner B, Sandberg MA, Hayes KC, Nicholson BW, Weigel-DiFranco C, Willett W. A randomized trial of vitamin A and vitamin E supplementation for retinitis pigmentosa. Arch Ophthalmol. 1993 Jun;111(6):761-72. doi: 10.1001/archopht.1993.01090060049022.

    PMID: 8512476BACKGROUND

  • Berson EL, Rosner B, Sandberg MA, Weigel-DiFranco C, Moser A, Brockhurst RJ, Hayes KC, Johnson CA, Anderson EJ, Gaudio AR, Willett WC, Schaefer EJ. Clinical trial of docosahexaenoic acid in patients with retinitis pigmentosa receiving vitamin A treatment. Arch Ophthalmol. 2004 Sep;122(9):1297-305. doi: 10.1001/archopht.122.9.1297.

    PMID: 15364708RESULT

  • Berson EL, Rosner B, Sandberg MA, Weigel-DiFranco C, Moser A, Brockhurst RJ, Hayes KC, Johnson CA, Anderson EJ, Gaudio AR, Willett WC, Schaefer EJ. Further evaluation of docosahexaenoic acid in patients with retinitis pigmentosa receiving vitamin A treatment: subgroup analyses. Arch Ophthalmol. 2004 Sep;122(9):1306-14. doi: 10.1001/archopht.122.9.1306.

    PMID: 15364709RESULT

  • Comander J, Weigel DiFranco C, Sanderson K, Place E, Maher M, Zampaglione E, Zhao Y, Huckfeldt RM, Bujakowska KM, Pierce E. Natural history of retinitis pigmentosa based on genotype, vitamin A/E supplementation, and an electroretinogram biomarker. JCI Insight. 2023 Aug 8;8(15):e167546. doi: 10.1172/jci.insight.167546.

    PMID: 37261916DERIVED

MeSH Terms

Conditions

Retinitis Pigmentosa

Interventions

Vitamin ADocosahexaenoic Acids

Condition Hierarchy (Ancestors)

Eye Diseases, HereditaryEye DiseasesRetinal DystrophiesRetinal DegenerationRetinal DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

RetinoidsCarotenoidsPolyenesAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCyclohexenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicTerpenesDiterpenesPigments, BiologicalBiological FactorsFatty Acids, Omega-3Dietary Fats, UnsaturatedDietary FatsFatsLipidsFatty Acids, UnsaturatedFatty AcidsFish OilsOils

Study Officials

  • Eliot Berson (Deceased), MD

    Berman-Gund Laboratory for the Study of Retinal Degenerations, Harvard Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
In this trial neither the participants, nor the clinicians, nor the investigators were aware of treatment group assignment.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR INVESTIGATOR
PI Title
coauthor/program manager

Study Record Dates

First Submitted

September 23, 1999

First Posted

September 24, 1999

Study Start

May 1, 1996

Primary Completion

September 1, 2002

Study Completion

September 1, 2002

Last Updated

March 8, 2023

Record last verified: 2023-02

Locations

US(1)