Background: Blood cell aggregation and adherence to vascular endothelium and inflammation play a central role in vaso-occlusive crisis in sickle cell disease. The antiaggregatory, antiadhesive, antiinflammatory, and vasodilatory omega-3 (n-3) fatty acids (DHA and EPA) are significantly reduced in patients with the disease.
Objective: The aim was to investigate the therapeutic potential of omega-3 fatty acids for patients with homozygous sickle cell disease in a randomized, placebo-controlled, double-blind trial.
Design: One hundred forty patients recruited from a single center in Sudan were randomly assigned and received, daily, 1 (age 2-4 y), 2 (age 5-10 y), 3 (age 11-16 y), or 4 (age ≥17 y) omega-3 capsules containing 277.8 mg DHA and 39.0 mg EPA or placebo for 1 y. Of these patients, 128 were followed up and the data were obtained. The primary and secondary endpoints-rates of clinical vaso-occlusive crisis and hemolytic events, blood transfusion rate, school attendance, and blood count-were analyzed by intention-to-treat analysis (n = 140).
Results: Omega-3 treatment reduced the median rate of clinical vaso-occlusive events (0 compared with 1.0 per year, P < 0.0001), severe anemia (3.2% compared with 16.4%; P < 0.05), blood transfusion (4.5% compared with 16.4%; P < 0.05), white blood cell count (14.4 ± 3.3 compared with 15.6 ± 4.0 ×10(3)/μL; P < 0.05), and the OR of the inability to attend school at least once during the study period because of illness related to the disease to 0.4 (95% CI: 0.2, 0.9; P < 0.05).
Conclusion: The findings of this trial, which need to be verified in a large multicenter study, suggest that omega-3 fatty acids can be an effective, safe, and affordable therapy for sickle cell anemia. This trial was registered with Current Controlled Trials as ISRCTN80844630.