Omega-3 Fatty Acids in Sickle Cell Disease

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-25

Study Completion Date

2018-10-15

Brief Summary

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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.

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Detailed Description

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Conditions

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Sickle Cell Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SCD-Omegatex™

single arm

Group Type EXPERIMENTAL

SCD-Omegatex™

Intervention Type DRUG

Subjects will receive SCD-Omegatex™ (Enteric Fish Oil 250 DHA/27 EPA Soft Gelatin Capsule, 450 mg) at one of two daily doses, orally, once a day for 6 months. The trial will follow a "3+3" design using two dose levels. In the phase I portion, subjects will be treated with a dose of 25 mg/kg/day DHA and EPA. If this is tolerated without dose limiting toxicity (DLT), a subsequent cohort of patients will be treated at a dose of 37.5 mg/kg/day with a maximum total daily dose of 4 grams. Once a maximum tolerated dose (MTD) is determined, subjects on the phase II portion of the study will be treated at that dose.

Interventions

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SCD-Omegatex™

Subjects will receive SCD-Omegatex™ (Enteric Fish Oil 250 DHA/27 EPA Soft Gelatin Capsule, 450 mg) at one of two daily doses, orally, once a day for 6 months. The trial will follow a "3+3" design using two dose levels. In the phase I portion, subjects will be treated with a dose of 25 mg/kg/day DHA and EPA. If this is tolerated without dose limiting toxicity (DLT), a subsequent cohort of patients will be treated at a dose of 37.5 mg/kg/day with a maximum total daily dose of 4 grams. Once a maximum tolerated dose (MTD) is determined, subjects on the phase II portion of the study will be treated at that dose.

Intervention Type DRUG

Other Intervention Names

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Enteric Fish Oil 250 DHA/27 EPA Soft Gelatin Capsule

Eligibility Criteria

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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

Minimum Eligible Age

8 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No