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

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ClinicalTrials.gov Identifier: NCT01202812
Recruitment Status : Unknown
Verified October 2010 by Thomas Jefferson University.
Recruitment status was:  Not yet recruiting
First Posted : September 16, 2010
Last Update Posted : October 25, 2010
Drexel University
Information provided by:
Thomas Jefferson University

Brief 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.

Condition or disease Intervention/treatment Phase
Sickle Cell Disease HEMOGLOBIN SS Hemoglobin S Beta-0 Thalassemia Inflammation Quality of Life Dietary Supplement: Omega-3 Fatty Acids: Eicosapentaenoic Acid (EPA) and Docosahexaenoic Acid (DHA) Other: Placebo Capsules Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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)
Study Start Date : October 2010
Estimated Primary Completion Date : March 2012
Estimated Study Completion Date : March 2012

Arm Intervention/treatment
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

Placebo Comparator: Placebo capsule Other: Placebo Capsules
Placebo capsules given by mouth daily for 6 months.
Other Name: - Placebo

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

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Ages Eligible for Study:   10 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01202812

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Contact: Marie Stuart, M.D. 215-955-1819 cell-215.847.1471 marie.stuart@jefferson.edu

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United States, Pennsylvania
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
Principal Investigator: Marie Stuart, M.D.         
Sub-Investigator: Suba Krishnan, M.D.         
Sub-Investigator: B.N. Yamaja Setty, Ph.D.         
St. Christopher's Hospital for Children, Drexel University
Philadelphia, Pennsylvania, United States, 19134-1095
Contact: Norma Lerner, M.D.    215-427-5261    norma.lerner@tenethealth.com   
Contact: Maureen Meier, RN, CCRC    215-427-3835    maureen.meier@tenethealth.com   
Sub-Investigator: Maureen Meier, RN, CCRC         
Sponsors and Collaborators
Thomas Jefferson University
Drexel University
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Principal Investigator: Marie Stuart, M.D. Thomas Jefferson University
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Responsible Party: Marie Stuart, MD, Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT01202812    
Other Study ID Numbers: 10F.161
First Posted: September 16, 2010    Key Record Dates
Last Update Posted: October 25, 2010
Last Verified: October 2010
Keywords provided by Thomas Jefferson University:
Sickle Cell Anemia
Sickle Cell Disease
Hemoglobin SS Disease
Hemoglobin S beta-0 Thalassemia
Quality of Life
Sickle Thalassemia
C-Reative Protein
Hemolytic Anemia
Omega-3 Fatty Acids
Eicosapentaenoic Acid
Docosahexaenoic Acid
Fish Oils
Drug: Placebo
Additional relevant MeSH terms:
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Anemia, Sickle Cell
Sickle Cell Trait
Pathologic Processes
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Hematologic Diseases
Genetic Diseases, Inborn