Omega-3 Fatty Acids in Sickle Cell Disease

Phase I/II Safety and Dose Escalation Trial of the Omega-3 Fatty Acids Docosahexaenoic Acid (DHA) and Eicosapentaenoic Acid (EPA) in Children and Young Adults With Sickle Cell Disease (SCD)

The purpose of this study is to determine the safety of a new formulation of the omega-3 fatty acids Docosahexaenoic Acid (DHA) and Eicosapentaenoic Acid (EPA) and to assess whether it decreases inflammation and inflammatory pain in children and young adults with Sickle Cell Disease.

Inclusion Criteria:

Subjects who meet all of the following criteria are eligible for enrollment into the study:

• Participant has signed the informed consent/assent with parent signing informed consent as age appropriate.
• Established diagnosis of HbSS, HbSC or HbSβo Thalassemia
• History of ≥1 vasoocclusive events (managed at home and/or in hospital) in preceding 12 months.
• Regular compliance with comprehensive care.
• Aged 8 years or greater and less than 26 years.
• At enrollment, subject should be in his/her baseline steady state and not in the midst of any acute complication due to SCD. Must be at least 2 weeks from infection or vasoocclusive crisis at time of screening labs

Exclusion Criteria:

• Baseline hemoglobin levels <5.5 gm/dL.
• Inability to swallow capsules
• Poor compliance with previous treatment regimens.
• Hepatic dysfunction
• Renal dysfunction
• PT and/or PTT ≥ 20% outside of normal
• Allergy to fish, shell fish or soy
• Triglyceride levels <80mg/dL.
• Pregnancy.
• Chronic Transfusion Therapy.
• Transfusion within the last 30 days.
• Treatment with any investigational drug or regular fish oil supplementations in last 60 days.
• Currently receiving another investigational agent, or on such an agent with the last 60 days.
• Dosage changes in preceding 3 months if on hydroxyurea
• Diagnosed bleeding disorder or patient on concomitant anti-coagulation.
• Conditional or abnormal result on most recent transcranial doppler or history of stroke.
• Other active chronic illness that could adversely affect subjects performance
• Children in Care
• Platelet count less than 100,000