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
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|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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||48 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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.
|Placebo Comparator: Placebo capsule||
Other: Placebo Capsules
Placebo capsules given by mouth daily for 6 months.
Other Name: - Placebo
- 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 ]
- 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|
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.
- 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.
- 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.
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
|Contact: Marie Stuart, M.D.||215-955-1819 firstname.lastname@example.org|
|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 email@example.com|
|Contact: Maureen Meier, RN, CCRC 215-427-3835 firstname.lastname@example.org|
|Sub-Investigator: Maureen Meier, RN, CCRC|
|Principal Investigator:||Marie Stuart, M.D.||Thomas Jefferson University|
|Responsible Party:||Marie Stuart, MD, Thomas Jefferson University|
|Other Study ID Numbers:||
|First Posted:||September 16, 2010 Key Record Dates|
|Last Update Posted:||October 25, 2010|
|Last Verified:||October 2010|
Sickle Cell Anemia
Sickle Cell Disease
Hemoglobin SS Disease
Hemoglobin S beta-0 Thalassemia
Quality of Life
Omega-3 Fatty Acids
Anemia, Sickle Cell
Sickle Cell Trait
Anemia, Hemolytic, Congenital
Genetic Diseases, Inborn