Study on Use of Omega-3 Fatty Acids to Improve Outcomes in Individuals With Sickle Cell Disease

The University of Alabama at Birmingham

Status: Active, not recruiting

Conditions: Sickle Cell Disease

Treatments: Dietary Supplement: Plant-based omega-3-FA

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05758766

IRB-300010261

K23HL173704 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

Sickle cell disease (SCD) is associated with significant morbidity and mortality. Pain and many adverse outcomes occurring in sickle cell disease are inflammatory driven. Recent data has shown that gut dysbiosis is present in individuals with sickle cell disease. Gut dysbiosis has been linked to inflammation in certain diseases. Omega -3-fatty acids (fish oil) has been shown to improve pain outcomes in individuals with sickle cell disease, but its acceptance is variable. The aim of this study is to determine if a plant-based omega-3-fatty acids will be more acceptable and also improve outcomes in individuals with sickle cell disease

Full description

Sickle cell disease (SCD) is associated with significant morbidity and mortality. Pain and many adverse outcomes occurring in sickle cell disease are inflammatory driven. Recent data has shown that gut dysbiosis is present in individuals with sickle cell disease. Gut dysbiosis has been linked to inflammation in certain diseases. Omega -3-fatty acids (fish oil) has been shown to improve pain outcomes in individuals with sickle cell disease, but its acceptance is variable. The aim of this study is to determine if a plant-based omega-3-fatty acids will be more acceptable and also improve outcomes in individuals with sickle cell disease.

Children aged 5-18 years will be randomized to receive a diet rich in omega-3-fatty acids versus a regular diet for 12 weeks after which there will be a cross over of arms after a 4-week wash out period. We will compare outcomes (including patient reported pain outcomes and improvement in inflammation markers) while on the omega-3 fatty acid rich diet.

Enrollment: 30 estimated patients

Sex: All

Ages: 5 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of sickle cell anemia HbSS or HbSB0 thal at steady state
• Age 5-18 years old

Exclusion criteria

• Age less than 5 years
• Age > 18 years old
• Chronic transfusion therapy
• Known to be pregnant
• Breastfeeding mothers
• Current use of antibiotics
• Use of pre or probiotic supplements
• PPI therapy
• Known allergy to FS

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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30 participants in 2 patient groups

Regular diet

No Intervention group

Description:

Participants will continue their regular diet.

Plant based omega 3 Fatty Acid

Experimental group

Description:

Participants ingest their regular diet supplemented with a plant-based omega-3-FA

Treatment:

Dietary Supplement: Plant-based omega-3-FA