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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by Thomas Jefferson University.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborators:
Drexel University
GlaxoSmithKline
Information provided by:
Thomas Jefferson University
ClinicalTrials.gov Identifier:
NCT01202812
First received: September 14, 2010
Last updated: October 22, 2010
Last verified: October 2010
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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)

Resource links provided by NLM:


Further study details as provided by Thomas Jefferson University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 48
Study Start Date: October 2010
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   10 Years to 19 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01202812

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

Locations
United States, Pennsylvania
St. Christopher's Hospital for Children, Drexel University Not yet recruiting
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         
Thomas Jefferson University Hospital Not yet recruiting
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.         
Sponsors and Collaborators
Thomas Jefferson University
Drexel University
GlaxoSmithKline
Investigators
Principal Investigator: Marie Stuart, M.D. Thomas Jefferson University
  More Information

Publications:
Dampier C, Lieff S, LeBeau P, Rhee S, McMurray M, Rogers Z, Smith-Whitley K, Wang W, and the Comprehensive Sickle Cell Centers (CSCC) Clinical Trial Consortium (CTC) Site Investigators. Health-related quality of life in children with sickle cell disease: A report from the Comprehensive Sickle Cell Centers Clinical Trial Consortium. Pediatr Blood Cancer 00:1-11, 2010.

Responsible Party: Marie Stuart, MD, Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT01202812     History of Changes
Other Study ID Numbers: 10F.161
Study First Received: September 14, 2010
Last Updated: October 22, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Thomas Jefferson University:
Sickle Cell Anemia
Sickle Cell Disease
Hemoglobin SS Disease
Hemoglobin S beta-0 Thalassemia
Inflammation
Quality of Life
Sickle Thalassemia
C-Reative Protein
Hemolytic Anemia
Hemostasis
Biomarkers
Coagulation
Omega-3 Fatty Acids
Eicosapentaenoic Acid
Docosahexaenoic Acid
Fish Oils
Drug: Placebo
Drug: LOVAZA

Additional relevant MeSH terms:
Anemia, Sickle Cell
Inflammation
Thalassemia
Anemia
Anemia, Hemolytic
Anemia, Hemolytic, Congenital
Genetic Diseases, Inborn
Hematologic Diseases
Hemoglobinopathies
Pathologic Processes

ClinicalTrials.gov processed this record on October 20, 2014