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Randomized Clinical Trial for Retinitis Pigmentosa

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2007 by National Eye Institute (NEI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Eye Institute (NEI)
ClinicalTrials.gov Identifier:
NCT00346333
First received: June 27, 2006
Last updated: March 23, 2010
Last verified: December 2007
History of Changes
  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
Inherited Retinal Degeneration
 Dietary Supplement: Nutritional supplement
Dietary Supplement: Vitamin A palmitate
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Clinical Trial for Retinitis Pigmentosa

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Total point score for the 30-2 program of the Humphrey Field analyzer (HFA) [ Time Frame: assessed annually ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Computer-averaged 30-Hz cone ERG amplitudes [ Time Frame: assessed annually ] [ Designated as safety issue: No ]
  • Visual acuity [ Time Frame: assessed annually ] [ Designated as safety issue: No ]

Enrollment: 241
Study Start Date: August 2003
Estimated Study Completion Date: December 2008
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Dietary Supplement: Nutritional supplement
    daily dose of nutritional supplement
    Dietary Supplement: Vitamin A palmitate
    15,000 IU/day of vitamin A palmitate unless indication of toxicity
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.

The 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 supplement 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 for the 30-2 program of the Humphrey Field analyzer (HFA). In addition, computer-averaged 30-Hz cone ERG amplitudes and visual acuity are measured annually.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have typical retinitis pigmentosa (RP)
  • Be between the ages of 18 and 60
  • 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
  • Hear on the telephone
  • Have a normal fasting serum vitamin A and normal liver function profile
  • Be a non-smoker
  • Eat a balanced diet
  • Be in good general health
  • Reside in the United States

Exclusion Criteria:

  • Women who are pregnant or planning to become pregnant (Vitamin A supplements can increase the risk of birth defects.)
  • Current participation in another clinical trial for RP
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00346333

Sponsors and Collaborators
National Eye Institute (NEI)
Investigators
Study Chair: Eliot Berson, MD Harvard Medical School
  More Information

Additional Information:
NEI Clinical Studies Database  This link exits the ClinicalTrials.gov site

No publications provided by National Eye Institute (NEI)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Eliot L. Berson, M.D., Harvard Medical School
ClinicalTrials.gov Identifier: NCT00346333     History of Changes
Other Study ID Numbers: NEI-126
Study First Received: June 27, 2006
Last Updated: March 23, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Retinal Degeneration
Retinitis
Retinitis Pigmentosa
Retinal Diseases
Eye Diseases
Eye Diseases, Hereditary
Retinal Dystrophies
Genetic Diseases, Inborn
Vitamin A
Vitamins
Retinol palmitate
 Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 21, 2013