Active — Not RecruitingNot Applicable

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

United States30 participantsStarted 2023-08-30

Plain-language 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

Who can participate

Age range5 Years – 18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Acute pain

Timeframe: 12 weeks

Chronic pain

Timeframe: 12 weeks

Trial details

NCT IDNCT05758766

SponsorUniversity of Alabama at Birmingham

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12-30

View on ClinicalTrials.gov More Sickle Cell Disease trials