A Randomized Trial of LOVAZA in Pediatric Sickle Cell Disease (SCD)
NCT ID: NCT01202812
Last Updated: 2010-10-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
48 participants
INTERVENTIONAL
2010-10-31
2012-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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LOVAZA
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.
Placebo capsule
Placebo Capsules
Placebo capsules given by mouth daily for 6 months.
Interventions
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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.
Placebo Capsules
Placebo capsules given by mouth daily for 6 months.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
10 Years
19 Years
ALL
No
Sponsors
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Drexel University
OTHER
GlaxoSmithKline
INDUSTRY
Thomas Jefferson University
OTHER
Responsible Party
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Thomas Jefferson University
Principal Investigators
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Marie Stuart, M.D.
Role: PRINCIPAL_INVESTIGATOR
Thomas Jefferson University
Locations
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Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
St. Christopher's Hospital for Children, Drexel University
Philadelphia, Pennsylvania, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Tomer A, Kasey S, Connor WE, Clark S, Harker LA, Eckman JR. Reduction of pain episodes and prothrombotic activity in sickle cell disease by dietary n-3 fatty acids. Thromb Haemost. 2001 Jun;85(6):966-74.
Krishnan S, Setty Y, Betal SG, Vijender V, Rao K, Dampier C, Stuart M. Increased levels of the inflammatory biomarker C-reactive protein at baseline are associated with childhood sickle cell vasocclusive crises. Br J Haematol. 2010 Mar;148(5):797-804. doi: 10.1111/j.1365-2141.2009.08013.x. Epub 2009 Dec 8.
Dampier C, Lieff S, LeBeau P, Rhee S, McMurray M, Rogers Z, Smith-Whitley K, Wang W; Comprehensive Sickle Cell Centers (CSCC) Clinical Trial Consortium (CTC). 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. 2010 Sep;55(3):485-94. doi: 10.1002/pbc.22497.
Bolarinwa AB, Oduwole O, Okebe J, Ogbenna AA, Otokiti OE, Olatinwo AT. Antioxidant supplementation for sickle cell disease. Cochrane Database Syst Rev. 2024 May 22;5(5):CD013590. doi: 10.1002/14651858.CD013590.pub2.
Other Identifiers
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10F.161
Identifier Type: -
Identifier Source: org_study_id