Search / Trial NCT00000114

Randomized Trial of Vitamin A and Vitamin E Supplementation for Retinitis Pigmentosa

Launched by NATIONAL EYE INSTITUTE (NEI) · Sep 23, 1999

Trial Information

Current as of December 08, 2024

Completed

Keywords

Retinitis Pigmentosa Vitamin Supplements

ClinConnect Summary

Retinitis pigmentosa (RP) is a group of inherited retinal degenerations with a worldwide prevalence of about 1 in 4,000. Patients typically report night blindness in adolescence and lose vision in the midperipheral followed by far-peripheral visual field in adulthood due to progressive loss of both rod and cone function. Most patients have reductions in central vision by age 50 to 80 years. Modern-day electroretinograms (ERGs) make it possible to record retinal responses from most patients with remaining vision and thereby monitor objectively the course of their disease.

While the natural ...

Gender

ALL

Eligibility criteria

  • Men and nonpregnant women between ages 18 and 49 years with common forms of RP were included. All eligible patients had retinal arteriolar attenuation, elevated dark adaptation thresholds, and reduced ERGs. Patients had best corrected Snellen visual acuity of 20/100 or better, central visual field diameter on the Goldman perimeter with V4 e white test light of 8 degrees or greater, and ERG amplitude of 2.5 or greater in response to 0.5-Hz white light or of 0.12 ultraviolet light or greater in response to 30-Hz white flickering light in at least one eye. In addition, patients had normal fasting serum retinol and serum liver function profile and weight above the lower fifth percentile for age, sex, and height. All patients had a total estimated pre-trial intake of vitamins A and E from diet plus pills not greater than 11,500 IU/day and 40 IU/day, respectively.

About National Eye Institute (Nei)

The National Eye Institute (NEI), part of the U.S. National Institutes of Health (NIH), is dedicated to conducting and supporting innovative research to understand, prevent, and treat eye diseases and vision disorders. As a leading sponsor of clinical trials, NEI aims to advance knowledge in ocular health through rigorous scientific inquiry and collaboration with researchers, healthcare professionals, and institutions. By fostering the development of new therapies and technologies, NEI plays a pivotal role in enhancing the quality of life for individuals affected by visual impairments and eye conditions.

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Timeline

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Estimated completion

Not reported

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