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

Quality of Life Clinical Trial

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01202812
• Other study ID #: 10F.161
• Status: Not yet recruiting
• Phase: Phase 2
• First received: September 14, 2010
• Last updated: October 22, 2010
• Start date: October 2010
• Est. completion date: March 2012

Study information

• Verified date: October 2010
• Source: Thomas Jefferson University
• Contact: Marie Stuart, M.D.
• Phone: 215-955-1819 cell-215.847.1471
• Email: marie.stuart[@]jefferson.edu
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 48
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 19 Years

Eligibility

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 HbSßo 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

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:
• Placebo Capsules
Placebo capsules given by mouth daily for 6 months.

Locations

Country	Name	City	State
United States	St. Christopher's Hospital for Children, Drexel University	Philadelphia	Pennsylvania
United States	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Thomas Jefferson University	Drexel University, GlaxoSmithKline

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No