NCT01202812

A Randomized Trial of LOVAZA in Pediatric Sickle Cell Disease (SCD)

Phase II Randomized Double-Blind Placebo-Controlled Trial of the Omega-3 Fatty Acids Eicosapentaenoic (EPA) and Docosahexaenoic Acid (DHA) in Pediatric Sickle Cell Disease (SCD)

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Thomas Jefferson University · Academic / Other
• Sex: All
• Age: 10 Years – 19 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to determine the effectiveness of LOVAZA (fish oil capsules) to decrease inflammation in children and adolescents with Sickle Cell Disease (SCD). It has been found that besides the damage caused by sickle red blood cells themselves, the inflammatory response that occurs in SCD patients could potentially play a significant role in the occurrence of painful episodes or pain crises. The investigators will also study whether the subject/caregiver feels that there is an improvement in the child's quality of life by taking the medication. Besides the effect of LOVAZA on inflammation,the investigators are also testing whether the drug will have a beneficial effect on blood clotting ability (which is known to be increased in SCD) and on the anemia (low red blood cells) that is part of the disease entity.

Conditions

• Sickle Cell Disease
• HEMOGLOBIN SS
• Hemoglobin S Beta-0 Thalassemia
• Inflammation
• Quality of Life

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Omega-3 Fatty Acids: Eicosapentaenoic Acid (EPA) and Docosahexaenoic Acid (DHA)	Eicosapentaenoic Acid (EPA)/Docosahexaenoic Acid (DHA) 30mg/kg (LOVAZA capsules) given by mouth daily for 6 months.
OTHER	Placebo Capsules	Placebo capsules given by mouth daily for 6 months.

Timeline

• Start date: 2010-10-01
• Primary completion: 2012-03-01
• Completion: 2012-03-01
• First posted: 2010-09-16
• Last updated: 2010-10-25

Locations

2 sites across 1 country: United States