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

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Sickle Cell Disease, HEMOGLOBIN SS, Hemoglobin S Beta-0 Thalassemia, Inflammation, Quality of Life

Intervention / Treatment
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* Dietary Supplement: Omega-3 Fatty Acids: Eicosapentaenoic Acid (EPA) and Docosahexaenoic Acid (DHA)
* Other: Placebo Capsules


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LOVAZA<br> | Dietary Supplement: Omega-3 Fatty Acids: Eicosapentaenoic Acid (EPA) and Docosahexaenoic Acid (DHA)<br>* Eicosapentaenoic Acid (EPA)/Docosahexaenoic Acid (DHA) 30mg/kg (LOVAZA capsules) given by mouth daily for 6 months.<br>* Other names: - Omega-3 Fatty Acid;|
| Placebo Comparator: Placebo capsule<br> | Other: Placebo Capsules<br>* Placebo capsules given by mouth daily for 6 months.<br>* Other names: - Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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). |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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). |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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