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

NCT01202812 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2010-10-25

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Drexel University

    collaborator OTHER

  • GlaxoSmithKline

    collaborator INDUSTRY

  • Thomas Jefferson University

    lead OTHER

Principal Investigators

  • Marie Stuart, M.D. · Thomas Jefferson University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2012-03-31
Completion
2012-03-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01202812 on ClinicalTrials.gov