OMEGA-3-FATTY ACIDS IN CHILDREN WITH SICKLE CELL DISEASE

The University of Alabama at Birmingham

Status: Begins enrollment this month

Conditions: Sickle Cell Disease (SCD)

Treatments: Dietary Supplement: Flaxseed

Study type: Interventional

Funder types: Other

Identifiers

NCT07530965

IRB-300016247

UAB (Other Grant/Funding Number)

Details and patient eligibility

About

The purpose of this feasibility study is to investigate the role of a dietary supplement in modulating the gut microbiota and improving pain outcomes in children with sickle cell disease (SCD).

Full description

Sickle cell disease (SCD) is associated with significant morbidity and mortality. Acute pain is the most frequent cause of hospitalization in children. Pain in sickle cell disease is 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. Our preliminary study showed that gut dysbiosis is linked to pain.

Omega -3-fatty acids (fish oil) has been shown to improve pain outcomes in individuals with SCD. Acceptance of fish oil varies given its fishy smell and taste. Flaxseed is a plant-based omega-3-fatty acid which has antioxidant and anti-inflammatory properties.

This study aims to conduct a feasibility trial on the use of flaxseed to modulating the gut microbiome and improving inflammatory markers and pain outcomes in children with SCD.

Enrollment: 20 estimated patients

Sex: All

Ages: 5 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

- Children 5-18 years with SCD at steady state. Steady state will be defined as not requiring an acute care visit for pain in the last 28 days.

Exclusion criteria

• current use of antibiotics except prophylactic penicillin
• current use of pre-or probiotic supplements
• current use of PPI therapy
• pregnant or lactating females
• individuals with known allergy to Flaxseed

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Flaxseed

Other group

Treatment:

Dietary Supplement: Flaxseed