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Clinical Trial 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


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT05758766
Study type Interventional
Source University of Alabama at Birmingham
Contact Dike
Phone 2056389918
Email cdike@uabmc.edu
Status Recruiting
Phase N/A
Start date August 30, 2023
Completion date December 30, 2025

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