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Safety assessment of docosahexaenoic acid in X-linked retinitis pigmentosa : the 4-year DHAX trial . PURPOSE Docosahexaenoic acid ( DHA ) continues to be evaluated and recommended as treatment and prophylaxis for various diseases . We recently assessed efficacy of high-dose DHA supplementation to slow vision loss in patients with X-linked retinitis pigmentosa ( XLRP ) in a randomized clinical trial . Because DHA is a highly unsaturated fatty acid , it could serve as a target for free-radical induced oxidation , resulting in increased oxidative stress . Biosafety was monitored during the 4-year trial to determine whether DHA supplementation was associated with identifiable risks . METHODS Males ( n = 78 ; 7-31 years ) meeting entry criteria were enrolled . The modified intent-to-treat cohort ( DHA = 33 ; placebo = 27 ) adhered to the protocol ≥ 1 year . Participants were randomized to an oral dose of 30 mg/kg/d DHA or placebo plus a daily multivitamin . Comprehensive metabolic analyses were assessed for group differences . Treatment-emergent adverse events including blood chemistry metabolites were recorded . RESULTS By year 4 , supplementation elevated plasma and red blood cell-DHA 4.4- and 3.6-fold , respectively , compared with the placebo group ( P < 0.00001 ) . Over the trial duration , no significant differences between DHA and placebo groups were found for vitamin A , vitamin E , platelet aggregation , antioxidant activity , lipoprotein cholesterol , or oxidized LDL levels ( all P > 0.14 ) . Adverse events were transient and not considered severe ( e.g. , gastrointestinal [ GI ] irritability , blood chemistry alterations ) . One participant was unable to tolerate persistent GI discomfort . CONCLUSIONS Long-term , high-dose DHA supplementation to patients with XLRP was associated with limited safety risks in this 4-year trial . Nevertheless , GI symptoms should be monitored in all patients taking high dose DHA especially those with personal or family history of GI disturbances . ( ClinicalTrials.gov number , NCT00100230 . ) .
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Intervention_Pharmacological
docosahexaenoic acid
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Intervention_Control
placebo
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Outcome_Physical
vision loss
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Outcome_Other
Biosafety
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Participant_Condition
X-linked retinitis pigmentosa :
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Participant_Condition
patients with X-linked retinitis pigmentosa ( XLRP )