Omega-3 Fatty Acids in Sickle Cell Disease
Status: | Terminated |
---|---|
Conditions: | Anemia |
Therapuetic Areas: | Hematology |
Healthy: | No |
Age Range: | 8 - 25 |
Updated: | 10/20/2018 |
Start Date: | January 25, 2018 |
End Date: | October 15, 2018 |
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.
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
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