Clinical trial of docosahexaenoic acid in patients with retinitis pigmentosa receiving vitamin A treatment
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
Archives of ophthalmology (Chicago, Ill. : 1960) · 112 citas
Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Marcadores de salud y funcionamiento
Quién lo pagó
- Financiación
- Financiación independiente
- Gobierno
- U.S. Department of Agriculture
- Organización sin fines de lucro
- Foundation Fighting Blindness
- Universidad u hospital
- Brandeis University
- Gobierno
- National Eye Institute
- Gobierno
- NEI NIH HHS
- Subvenciones
- National Eye Institute (U10 EY 11030)
Según 5 financiadores declarados.
Publicación
- Publicado
- 2004-09-01 · Arch Ophthalmol · vol. 122 · número 9 · pág. 1297
- Editorial
- American Medical Association
- Citado
- 175 citas · más que el 86% de estudios similares · 2.1× el promedio de su campo
- Referencias
- 52 trabajos
- Acceso
- De pago
- Áreas de investigación
- Retinal Development and Disorders · Retinal Diseases and Treatments · Fatty Acid Research and Health
- Palabras clave
- docosahexaenoic acid, omega-3 fatty acids, retinitis pigmentosa, vitamin A supplementation, retinyl palmitate, retinal degeneration, visual field sensitivity, electroretinogram, visual acuity, disease progression, dietary omega-3 fatty acids, safety and tolerability, long-term supplementation
- MeSH
- humans, vision disorders, retinitis pigmentosa, vitamin e, docosahexaenoic acids, electroretinography, drug therapy, combination, administration, oral, pilot projects, double-blind method, visual fields, adolescent, adult, middle aged, female, male
1 autor
- Eliot L. Berson🇺🇸 · autor de correspondenciaHarvard University
Resumen
El texto original del estudio, en el idioma en que se publicó.
Objective
To determine whether a therapeutic dose of docosahexaenoic acid (DHA), an omega-3 fatty acid, will slow the course of retinal degeneration in adult patients with retinitis pigmentosa who are also receiving vitamin A.
Design
Randomized, controlled, double-masked trial of 221 patients, aged 18 to 55 years, evaluated over a 4-year interval. Patients were given either 1200 mg/d of docosahexaenoic acid or control capsules. All were given 15 000 IU/d of vitamin A (given as retinyl palmitate). Randomization considered genetic type and baseline dietary omega-3 fatty acid intake.
Main outcome measures
The primary outcome measure was the total point score for the 30-2 program of the Humphrey field analyzer; secondary outcome measures were the total point score for the 30-2 and 30/60-1 programs combined, 30-Hz electroretinogram amplitude, and Early Treatment Diabetic Rentinopathy Study visual acuity.
Results
No significant differences in decline in ocular function were found between the docosahexaenoic acid plus vitamin A (DHA + A) group and control plus vitamin A (control + A) group over a 4-year interval among all 221 randomized patients or among the 208 patients who completed all 4 follow-up visits. The mean annual rate of loss of sensitivity for the Humphrey Field Analyzer 30-2 program was 37 dB for the DHA + A group and 38 dB for the control + A group (P =.88). For the Humphrey Field Analyzer 30-2 and 30/60-1 programs combined, the mean annual rates of loss of field sensitivity were 57 dB for the DHA + A group and 60 dB (P =.73) for control + A group. No toxic adverse effects were observed. No significant differences by treatment group assignment were observed within genetic types or within the category of baseline omega-3 fatty acid intake.
Conclusion
In patients assigned to receive 15 000 IU/d of vitamin A, this randomized trial showed that 1200 mg/d of docosahexaenoic acid supplementation over a 4-year interval did not, on average, slow the course of disease in patients with retinitis pigmentosa.
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial.
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