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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
4
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.
Nemours/Alfred I duPont Hospital for Children
Wilmington, Delaware, United States
Clinical Safety, in a Dose Escalation Trial of SCD-Omegatex™ as Evidenced by an Absence of Adverse Events.
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.
Time frame: 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
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.
Time frame: 6 months
Health-associated Quality of Life
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.
Time frame: 6 months
Number of Days With Pain Measured by iPad Daily Report Pain Calendar
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.
Time frame: 8 months
Changes in Individual Thermal Sensitivity Thresholds by QST
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.
Time frame: 8 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.