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Effect of omega-3 (n-3) fatty acid supplementation in patients with sickle cell anemia: randomized, double-blind, placebo-controlled trial.

Abstract

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.

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  • Authors+Show Affiliations

    ,

    Faculty of Life Sciences and Computing, London Metropolitan University, London, United Kingdom.

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    Source

    MeSH

    Adolescent
    Anemia, Sickle Cell
    Anti-Inflammatory Agents
    Child
    Child, Preschool
    Dietary Supplements
    Double-Blind Method
    Endpoint Determination
    Fatty Acids, Omega-3
    Female
    Follow-Up Studies
    Humans
    Male
    Sudan
    Treatment Outcome
    Vasodilator Agents

    Pub Type(s)

    Journal Article
    Randomized Controlled Trial
    Research Support, Non-U.S. Gov't

    Language

    eng

    PubMed ID

    23193009

    Citation

    TY - JOUR T1 - Effect of omega-3 (n-3) fatty acid supplementation in patients with sickle cell anemia: randomized, double-blind, placebo-controlled trial. AU - Daak,Ahmed A, AU - Ghebremeskel,Kebreab, AU - Hassan,Zahir, AU - Attallah,Bakhita, AU - Azan,Haj H, AU - Elbashir,Mustafa I, AU - Crawford,Michael, Y1 - 2012/11/28/ PY - 2012/11/30/entrez PY - 2012/11/30/pubmed PY - 2013/3/8/medline SP - 37 EP - 44 JF - The American journal of clinical nutrition JO - Am. J. Clin. Nutr. VL - 97 IS - 1 N2 - 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. SN - 1938-3207 UR - https://www.unboundmedicine.com/medline/citation/23193009/full_citation L2 - http://www.ajcn.org/cgi/pmidlookup?view=long&amp;pmid=23193009 ER -