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DK Wheaton, DR Hoffman, KG Locke, RB Watkins, DG Birch; Safety Assessment Of Docosahexaenoic Acid (DHA) Supplementation In A 4-Year Randomized Clinical Trial In X-linked Retinitis Pigmentosa (XLRP) . Invest. Ophthalmol. Vis. Sci. 2002;43(13):2413.
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Purpose: In a placebo-controlled trial to elevate blood-DHA levels in patients with XLRP, the goal was to assess the potential benefit of supplementation in altering disease progression. However, DHA (22:6w3) is a highly unsaturated long-chain fatty acid and is considered a target molecule for free-radical oxidative damage. Thus, nutritional provision of DHA in a treatment protocol for XLRP may be contra-indicated. Here, non-ocular adverse events as well as antioxidant and blood lipid profiles were assessed at the conclusion of a 4-year supplementation trial. Methods: Patients (n=44) were enrolled in a randomized, double-blind, clinical trial and provided either DHA (400mg/day) or a corn/soy oil placebo. Blood samples were collected every six months for the duration of the trial. Biological safety analysis included blood lipid fatty acid determination, plasma vitamin A & E levels, platelet aggregation, and plasma antioxidant capacity. Results: DHA supplementation elevated blood lipid DHA by 2.5-fold compared to the placebo group. All non-ocular adverse events reported were minor. Plasma vitamin A levels remained unchanged during the trial. Mean plasma vitamin E values for all patients were within 95% confidence intervals for a normative population. After 4 years of DHA supplementation, platelet aggregation and plasma antioxidant capacity were not compromised. Conclusion: The long-term DHA supplementation to patients with XLRP was associated with no identifiable safety risks in this 4-year trial.
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