Omega-3 Fatty Acids in Sickle Cell Disease

• Status: Terminated
• Trial end date: 2018-10-15
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Robin E. Miller
• Collaborators: National Institute of General Medical Sciences (NIGMS); Solutex GC, S.L.; Thomas Jefferson University

Criteria

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