Omega-3 Fatty Acids in Sickle Cell Disease
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ClinicalTrials.gov Identifier: NCT02947100 |
Recruitment Status :
Terminated
(manufacturing problem with study drug)
First Posted : October 27, 2016
Results First Posted : October 19, 2020
Last Update Posted : October 19, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Sickle Cell Disease | Drug: SCD-Omegatex™ | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 4 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | 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) |
Actual Study Start Date : | January 25, 2018 |
Actual Primary Completion Date : | October 5, 2018 |
Actual Study Completion Date : | October 15, 2018 |

Arm | Intervention/treatment |
---|---|
Experimental: SCD-Omegatex™
single arm
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Drug: 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.
Other Name: Enteric Fish Oil 250 DHA/27 EPA Soft Gelatin Capsule |
- Clinical Safety, in a Dose Escalation Trial of SCD-Omegatex™ as Evidenced by an Absence of Adverse Events. [ Time Frame: 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.
- Determine Whether 6 Months of Supplementation With SCD-Omegatex™ Will Reduce Thermal Sensitivity by Quantitative Sensory Testing to Below Pre-treatment Levels [ Time Frame: 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.
- Health-associated Quality of Life [ Time Frame: 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.
- Number of Days With Pain Measured by iPad Daily Report Pain Calendar [ Time Frame: 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 [ Time Frame: 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.
- Thrombin Generation as Assessed by Calibrated Automated Thrombogram [ Time Frame: 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.
- High Sensitivity C-reactive Protein (mg/L) [ Time Frame: 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.
- Plasma Lipidomic Analysis [ Time Frame: 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.
- Urine Resolvin D1 (pg/mg Creatinine) [ Time Frame: 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.
- Plasma Levels of Lactate Dehydrogenase (IU/L) [ Time Frame: 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.
- Fetal Hemoglobin (%) [ Time Frame: 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.
- Analysis of Pro and Anti-inflammatory Cytokines in Plasma Including Interleukin (IL)1-beta, IL-4, IL-6, IL-8, IL-10 and Tumor Necrosis Factor (TNF) Alpha ( pg/ml) [ Time Frame: 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.
- Plasma Endothelin-1(pg/ml) [ Time Frame: 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.
- Plasma Levels Soluble Vascular Adhesion Molecule -1 (VCAM-1) (ng/ml) [ Time Frame: 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.
- Plasma Levels of Soluble P-selectin (ng/ml) [ Time Frame: 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.
- Plasma Levels of Soluble L-selectin (ng/ml) [ Time Frame: 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.
- Hemostatic Markers in Plasma Including D-dimers and Prothrombin Fragment 1.2 (Nmol/L) [ Time Frame: 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.

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Ages Eligible for Study: | 8 Years to 25 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02947100
United States, Delaware | |
Nemours/Alfred I duPont Hospital for Children | |
Wilmington, Delaware, United States, 19899 |
Principal Investigator: | Robin E Miller, MD | Nemours Children's Clinic |
Documents provided by Robin E. Miller, Nemours Children's Clinic:
Responsible Party: | Robin E. Miller, Physician, Nemours Children's Clinic |
ClinicalTrials.gov Identifier: | NCT02947100 |
Other Study ID Numbers: |
RM002 P20GM109021 ( U.S. NIH Grant/Contract ) |
First Posted: | October 27, 2016 Key Record Dates |
Results First Posted: | October 19, 2020 |
Last Update Posted: | October 19, 2020 |
Last Verified: | September 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Sickle Cell Disease omega-3 fatty acids Docosahexaenoic Acid (DHA) Eicosapentaenoic Acid (EPA) |
Anemia, Sickle Cell Anemia, Hemolytic, Congenital Anemia, Hemolytic Anemia |
Hematologic Diseases Hemoglobinopathies Genetic Diseases, Inborn |