Omega-3 Fatty Acids in Sickle Cell Disease

Robin E. Miller

Status and phase

Terminated

Phase 2

Phase 1

Conditions

Sickle Cell Disease

Treatments

Drug: SCD-Omegatex™

Study type

Interventional

Funder types

Other

Industry

NIH

Identifiers

NCT02947100

P20GM109021 (U.S. NIH Grant/Contract)

RM002

Details and patient eligibility

About

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.

Enrollment

4 patients

Sex

All

Ages

8 to 25 years old

Volunteers

No Healthy Volunteers

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