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Randomized Controlled Trial Comparative Study Clinical Trial
A randomized, placebo-controlled clinical trial of docosahexaenoic acid supplementation for X-linked retinitis pigmentosa.
- Dennis R Hoffman, Kirsten G Locke, Dianna H Wheaton, Gary E Fish, Rand Spencer, and David G Birch.
- Retina Foundation of the Southwest, Dallas, Texas 75231, USA. dhoffman@retinafoundation.org
- Am. J. Ophthalmol. 2004 Apr 1; 137 (4): 704-18.
PurposeLow docosahexaenoic acid (DHA) in X-linked retinitis pigmentosa (XLRP) may influence retinal function. The goals of this study were to elevate blood DHA levels and determine the effect on the rate of disease progression.DesignIn a 4-year prospective randomized clinical trial, male patients with XLRP (mean age = 16 years; range = 4-38 years) received DHA (400 mg/d; n = 23; +DHA group) or placebo (n = 21) capsules.MethodsRed blood cell (RBC)-DHA concentrations were assessed every 6 months. Full-field cone electroretinograms (ERGs; the primary outcome measure), visual acuity, dark-adaptation, visual fields, rod ERGs, and fundus photos were recorded annually.ResultsIn the +DHA group, RBC-DHA increased 2.5-fold over placebo levels (70 vs 28 mg DHA/l). Repeated measures analysis of variance for cone ERG showed a significant main effect of year (P <.0001) but not of group (P =.16). Preservation of cone ERG function correlated with RBC-DHA (P =.018), and there was less change in fundus appearance in the +DHA group (P =.04). Neither visual acuity nor visual fields were changed. In subset analysis, DHA supplementation was beneficial in reducing rod ERG functional loss in patients aged <12 years (P =.040) and preserving cone ERG function in patients > or =12 years (P =.038).ConclusionsAlthough DHA-supplemented patients had significantly elevated mean RBC-DHA levels, the rate of cone ERG functional loss was not significantly different between groups. Supplemental analyses provided evidence for a DHA benefit and a direction for subsequent investigations.
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