Omega-3 Fatty Acids in Sickle Cell Disease

Stopped early · Phase 1/Phase 2

Conditions studied: Sickle Cell Disease

In brief

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.

Key facts

Study ID

NCT02947100

Run by

Robin E. Miller

People needed

4

Starts

2018-01-25

Expected to finish

2018-10-15

Last updated by the study team

2020-10-19

Who can join

Age: 8 and older, up to 25. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Nemours/Alfred I duPont Hospital for Children — Wilmington, Delaware, United States

Full record on ClinicalTrials.gov

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