drugset / Trial / NCT02947100
Omega-3 Fatty Acids in Sickle Cell Disease
Phase 1/2
Terminated
4 enrolled
Robin E. Miller
National Institute of General Medical Sciences (NIGMS) · collabSolutex GC S.L. · collabThomas Jefferson University · collab
NaSingle-groupOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2018-01-25
- Primary completion
- 2018-10-05
- Completion
- 2018-10-15
Outcome
Outcome not reported
Stopped: “manufacturing problem with study drug”
Publications
- Background Daak AA, Ghebremeskel K, Hassan Z, Attallah B, Azan HH, Elbashir MI, Crawford M. Effect of omega-3 (n-3) fatty acid supplementation in patients with sickle cell anemia: randomized, double-blind, placebo-controlled trial. Am J Clin Nutr. 2013 Jan;97(1):37-44. doi: 10.3945/ajcn.112.036319. Epub 2012 Nov 28.
- Background Serhan CN. Resolution phase of inflammation: novel endogenous anti-inflammatory and proresolving lipid mediators and pathways. Annu Rev Immunol. 2007;25:101-37. doi: 10.1146/annurev.immunol.25.022106.141647.
- Background Calder PC. Marine omega-3 fatty acids and inflammatory processes: Effects, mechanisms and clinical relevance. Biochim Biophys Acta. 2015 Apr;1851(4):469-84. doi: 10.1016/j.bbalip.2014.08.010. Epub 2014 Aug 20.
- Background Tomer A, Kasey S, Connor WE, Clark S, Harker LA, Eckman JR. Reduction of pain episodes and prothrombotic activity in sickle cell disease by dietary n-3 fatty acids. Thromb Haemost. 2001 Jun;85(6):966-74.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | SCD-Omegatex™ | Unknown | 25 mg/kg | Oral |
| Subject | SCD-Omegatex™ | Unknown | 37.5 mg/kg | Oral |