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

October 22, 2010 updated by: Thomas Jefferson University

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)

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

48

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University Hospital
        • Principal Investigator:
          • Marie Stuart, M.D.
        • Sub-Investigator:
          • Suba Krishnan, M.D.
        • Sub-Investigator:
          • B.N. Yamaja Setty, Ph.D.
      • Philadelphia, Pennsylvania, United States, 19134-1095
        • St. Christopher's Hospital for Children, Drexel University
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Maureen Meier, RN, CCRC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 19 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Subjects who meet all of the following criteria are eligible for enrollment into the study:

  • Participant has signed the informed consent/assent with parent signing informed consent as age appropriate.
  • Established diagnosis of HbSS or HbSβo Thal.
  • History of ≥3 vasocclusive pain events in preceding 12 months.
  • Regular compliance with comprehensive care.
  • Aged 10 years or greater and less than 20 years.
  • At enrollment, subject should be in his/her steady or baseline state.

Exclusion Criteria

  • Subjects with Hb levels <5.5gm/dL.
  • Inability to take or tolerate oral medications.
  • Poor compliance with previous treatment regimens.
  • Hepatic dysfunction (SGPT also known as ALT >2X upper limit of normal or conjugated bilirubin >2X the patients baseline within the last 6 weeks).
  • Renal dysfunction (A creatinine level within the past 6 weeks of ≥ 1.0mg/dL for children and ≥ 1.2mg/dL for a subject ≥ 18 years of age).
  • Allergy to fish or shell fish.
  • Triglyceride levels <80mg/dL.
  • Pregnancy.
  • Chronic Transfusion Therapy.
  • Transfusion within the last 30 days.
  • Persistent pain from sickle-complications (e.g. avascular necrosis).
  • A vasocclusive pain episode lasting longer than 2 weeks or >12 pain episodes in preceding year.
  • Daily narcotic usage.
  • Treatment with any investigational drug or regular fish oil supplementations in last 60 days.
  • Currently receiving another investigational agent, or on such an agent with the last 60 days.
  • Dosage changes in preceding 3 months if on hydroxyurea.
  • Bleeding disorder or patient on concomitant anti-coagulation.
  • Conditional or abnormal TCD result or stroke.
  • Other chronic illness that could adversely affect subjects performance such as HIV or TB.
  • Children in Care (CiC): A child in care is a child who has been placed under the control or protection of an agency, organization, institution or entity by the courts, the government or a government body, acting in accordance with powers conferred on them by law or regulation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo capsule
Other: Placebo Capsules
Placebo capsules given by mouth daily for 6 months.
Other Names:
  • - Placebo
Experimental: LOVAZA
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 Names:
  • - Fish Oils
  • - Eicosapentaenoic Acid
  • - Docosahexaenoic Acid
  • - Omega-3 Fatty Acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To determine whether supplementation with LOVAZA will exert an anti-inflammatory effect by decreasing levels of the inflammatory biomarker high sensitivity C Reactive Protein (hsCRP) in children and adolescents with Sickle Cell Disease (SCD).
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
To determine whether supplementation with LOVAZA will increase health-associated quality of life (QoL) responses as they relate to clinical vasocclusive events (VOC) in children and adolescents with Sickle Cell Disease (SCD).
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Thomas Jefferson University

Collaborators

GlaxoSmithKline
Drexel University

Investigators

  • Principal Investigator: Marie Stuart, M.D., Thomas Jefferson University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Anticipated)

March 1, 2012

Study Completion (Anticipated)

March 1, 2012

Study Registration Dates

First Submitted

September 14, 2010

First Submitted That Met QC Criteria

September 15, 2010

First Posted (Estimate)

September 16, 2010

Study Record Updates

Last Update Posted (Estimate)

October 25, 2010

Last Update Submitted That Met QC Criteria

October 22, 2010

Last Verified

October 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10F.161

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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