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 point of contact

Marie Stuart, M.D.
215-955-1819 cell-215.847.1471
[email protected]

Locations

2 United States sites

Age

10 to 19 Years

Genotypes

HbSS

Phase

Phase 2

Study type

Interventional

Gender

All

Interventions

Dietary Supplement

Other

Compensation

Unknown

About the study

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.

participation requirements

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.

participation restrictions

– 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.

Locations

  • Philadelphia, Pennsylvania, United States, Thomas Jefferson University Hospital, 19107
  • Philadelphia, Pennsylvania, United States, St. Christopher's Hospital for Children, Drexel University, 19134-1095