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

NCT01202812 | Unknown Phase 2 DMC

• 1 other identifier: 10F.161
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (2)

LOVAZA

EXPERIMENTAL

Dietary Supplement: Omega-3 Fatty Acids: Eicosapentaenoic Acid (EPA) and Docosahexaenoic Acid (DHA)

Placebo capsule

PLACEBO COMPARATOR

Other: Placebo Capsules

Interventions

Omega-3 Fatty Acids: Eicosapentaenoic Acid (EPA) and Docosahexaenoic Acid (DHA) DIETARY_SUPPLEMENT

Eicosapentaenoic Acid (EPA)/Docosahexaenoic Acid (DHA) 30mg/kg (LOVAZA capsules) given by mouth daily for 6 months.

Also known as: - Fish Oils, - Eicosapentaenoic Acid, - Docosahexaenoic Acid, - Omega-3 Fatty Acid

LOVAZA

Placebo Capsules OTHER

Placebo capsules given by mouth daily for 6 months.

Also known as: - Placebo

Placebo capsule

Eligibility Criteria

• Age: 10 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Thomas Jefferson University: lead
• Drexel University: collaborator
• GlaxoSmithKline: collaborator

Study Sites (2)

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

St. Christopher's Hospital for Children, Drexel University

Philadelphia, Pennsylvania, 19134-1095, United States

Location

Related Publications (4)

• 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.

  PMID: 11434703 BACKGROUND

• 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.

  PMID: 19995398 BACKGROUND

• 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.

  PMID: 20658620 BACKGROUND

• 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.

  PMID: 38775255 DERIVED

MeSH Terms

Conditions

Anemia, Sickle Cell; Inflammation; Anemia, Hemolytic; Thrombosis

Interventions

Docosahexaenoic Acids; Fish Oils; Eicosapentaenoic Acid; Fatty Acids, Omega-3

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Oils; Eicosanoids

Study Officials

• Marie Stuart, M.D.

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marie Stuart, M.D.

CONTACT

215-955-1819 cell-215.847.1471; marie.stuart@jefferson.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 14, 2010
• First Posted: September 16, 2010
• Study Start: October 1, 2010
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: October 25, 2010

Record last verified: 2010-10

Locations

US (2)