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

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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
We found this trial at
1
site
Wilmington, Delaware 19803
Phone: 302-651-5500
?
mi
from
Wilmington, DE
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