Omega-3 Fatty Acids in Sickle Cell Disease

September 22, 2020 updated by: Robin E. Miller

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

4

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Delaware
      • Wilmington, Delaware, United States, 19899
        • Nemours/Alfred I DuPont Hospital for Children

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 25 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SCD-Omegatex™
single arm
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 Names:
  • Enteric Fish Oil 250 DHA/27 EPA Soft Gelatin Capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months with continuous monitoring
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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months
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.
8 months
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.
8 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months
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.
6 months
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.
6 months
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.
6 months
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.
6 months
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.
6 months
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.
6 months
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.
6 months
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.
6 months
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.
6 months
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.
6 months
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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Robin E. Miller

Collaborators

National Institute of General Medical Sciences (NIGMS)
Thomas Jefferson University
Solutex GC S.L.

Investigators

  • Principal Investigator: Robin E Miller, MD, Nemours Children's Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 25, 2018

Primary Completion (Actual)

October 5, 2018

Study Completion (Actual)

October 15, 2018

Study Registration Dates

First Submitted

October 18, 2016

First Submitted That Met QC Criteria

October 25, 2016

First Posted (Estimate)

October 27, 2016

Study Record Updates

Last Update Posted (Actual)

October 19, 2020

Last Update Submitted That Met QC Criteria

September 22, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RM002
  • P20GM109021 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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