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 be 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.
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.
Clareo Health | A Randomized Trial of LOVAZA in Pediatric Sickle Cell Disease (SCD)
