NCT07530965

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

A Single Arm/ Open Label Feasibility Trial of Omega-3- Fatty Acids in Children With Sickle Cell Disease

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: All
• Age: 5 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed 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.

Conditions

• Sickle Cell Disease (SCD)

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Flaxseed	Flaxseed

Timeline

• Start date: 2026-06-01
• Primary completion: 2027-12-31
• Completion: 2028-12-31
• First posted: 2026-04-15
• Last updated: 2026-04-15