Omega-3 Fatty Acids in Sickle Cell Disease

Phase 1

Terminated

Brief 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
SCD-Omegatex™	SCD-Omegatex™	single arm

Primary Outcome Measures

Name	Time	Method
Determine Whether 6 Months of Supplementation With SCD-Omegatex™ Will Reduce Thermal Sensitivity by Quantitative Sensory Testing to Below Pre-treatment Levels	6 months	No results are available from any outcome measures as study was stopped early due to manufacturing issues with study drug and will not be reopened.
Clinical Safety, in a Dose Escalation Trial of SCD-Omegatex™ as Evidenced by an Absence of Adverse Events.	6 months with continuous monitoring	No results are available from any outcome measures as study was stopped early due to manufacturing issues with study drug and will not be reopened.

Secondary Outcome Measures

Name	Time	Method
Number of Days With Pain Measured by iPad Daily Report Pain Calendar	8 months	No results are available from any outcome measures as study was stopped early due to manufacturing issues with study drug and will not be reopened.
Changes in Individual Thermal Sensitivity Thresholds by QST	8 months	No results are available from any outcome measures as study was stopped early due to manufacturing issues with study drug and will not be reopened.
Health-associated Quality of Life	6 months	No results are available from any outcome measures as study was stopped early due to manufacturing issues with study drug and will not be reopened.