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

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01202812
Study type	Interventional
Source	Thomas Jefferson University
Contact	Marie Stuart, M.D.
Phone	215-955-1819 cell-215.847.1471
Email	marie.stuart@jefferson.edu
Status	Not yet recruiting
Phase	Phase 2
Start date	October 2010
Completion date	March 2012

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