Search / Trial NCT00000116

Randomized Trial of DHA for Retinitis Pigmentosa Patients Receiving Vitamin A

Launched by CAROL WEIGEL DIFRANCO · Sep 23, 1999

Trial Information

Current as of December 26, 2024

Completed

Keywords

ClinConnect Summary

Retinitis pigmentosa (RP) is a group of inherited retinal degenerations with a worldwide prevalence of approximately 1 in 4,000. Patients typically report night blindness and difficulty with midperipheral visual field in adolescence. As the condition progresses, they lose far peripheral visual field. Most patients have reductions in central vision by age 50 to 80 years. Based on electroretinograms (ERGs), the course of the disease can be slowed on average among adults on 15,000 IU/day of vitamin A palmitate. While conducting the trial on the effects of vitamin A on RP, it became apparent th...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 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
  • Exclusion criteria:
  • 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

Trial Officials

Eliot Berson (Deceased), MD

Principal Investigator

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

About Carol Weigel Difranco

Carol Weigel DiFranco is a dedicated clinical trial sponsor with a strong commitment to advancing medical research and improving patient outcomes. With extensive experience in the healthcare sector, she focuses on innovative trial designs and rigorous methodologies to ensure the integrity and efficacy of clinical studies. Her leadership emphasizes collaboration with research institutions, regulatory bodies, and patient communities, fostering an environment that prioritizes ethical standards and scientific excellence. Through her efforts, Carol aims to contribute significantly to the development of safe and effective therapies that address unmet medical needs.

Locations

Boston, Massachusetts, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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