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

Not Applicable

Recruiting

• Conditions: Sickle Cell Disease

• Registration Number: NCT05758766
• Lead Sponsor: University of Alabama at Birmingham

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2023-02-14
• Study First Submitted QC: 2023-03-06
• Study First Posted: 2023-03-07
• Study Start: 2023-08-30
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-14
• Last Update Posted: 2025-02-19
• Primary Completion: 2026-12-30
• Study Completion: 2026-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Acute pain	12 weeks	Decrease in acute pain frequency measured with weekly pain diaries and acute care visits for pain
Chronic pain	12 weeks	Improvement in quality of life measured using a validated questionnaire

Secondary Outcome Measures

Name	Time	Method
Inflammation	12 weeks	Decrease in inflammation as measured by inflammatory markers

Trial Locations

Locations (1)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States