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Randomized Trial for Retinitis Pigmentosa

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00000116
First Posted: September 24, 1999
Last Update Posted: September 17, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Eye Institute (NEI)
  Purpose
The purpose of this trial is to determine whether a nutritional supplement in addition to vitamin A will slow the course of retinitis pigmentosa.

Condition Intervention Phase
Retinitis Pigmentosa Drug: Vitamin A Drug: Nutritional Supplement Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Randomized Trial for Retinitis Pigmentosa

Resource links provided by NLM:


Further study details as provided by National Eye Institute (NEI):

Study Start Date: May 1996
Estimated Study Completion Date: September 1997
Detailed Description:

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 that another substance in the diet could be affecting the course of the disease. This prompted the present randomized, controlled trial.

This study is a randomized, controlled, double-masked trial with a planned duration of 5 years. Patients with the common forms of RP are assigned to either a test or a control group. All receive 15,000 IU/day of vitamin A palmitate in addition to the capsules under study. Participants will not know the contents of the supplement or the group to which they have been assigned until the end of the trial. The main outcome measurement is the total point score on the Humphrey Field Analyzer (HFA). In addition, computer-averaged 30-Hz cone ERG amplitudes and visual acuity are measured annually.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 56 Years   (Adult)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

Eligible patients must:

  • Be between the ages of 18 and 56
  • Be able to see the entire face of someone sitting across the table from them without scanning
  • Read newspaper-size print without special magnifying aids
  • Walk unaided in daylight
  • Have a normal fasting serum vitamin A and normal liver function profile
  • Be in good general health
  • Reside in the United States

Exclusion Criteria:

  • Women who are pregnant or planning to become pregnant cannot be included because of the risk of birth defects that could occur while they are on a vitamin A supplement.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000116


Locations
United States, Massachusetts
Berman-Gund Laboratory for the Study of Retinal Degenerations, Harvard Medical School, Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
National Eye Institute (NEI)
Investigators
Study Chair: Eliot Berson, MD Berman-Gund Laboratory for the Study of Retinal Degenerations, Harvard Medical School
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00000116     History of Changes
Other Study ID Numbers: NEI-12
First Submitted: September 23, 1999
First Posted: September 24, 1999
Last Update Posted: September 17, 2009
Last Verified: September 2009

Additional relevant MeSH terms:
Retinitis
Retinitis Pigmentosa
Cone-Rod Dystrophies
Retinal Diseases
Eye Diseases
Eye Diseases, Hereditary
Retinal Dystrophies
Retinal Degeneration
Genetic Diseases, Inborn
Vitamin A
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs