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

Last updated: February 14, 2025
Sponsor: University of Alabama at Birmingham
Overall Status: Active - Recruiting

Phase

N/A

Condition

Sickle Cell Disease

Red Blood Cell Disorders

Treatment

Plant-based omega-3-FA

Clinical Study ID

NCT05758766
IRB-300010261
K23HL173704
  • Ages 5-18
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosis of sickle cell anemia HbSS or HbSB0 thal at steady state

  • Age 5-18 years old

Exclusion

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

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: Plant-based omega-3-FA
Phase:
Study Start date:
August 30, 2023
Estimated Completion Date:
December 30, 2026

Study 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.

Connect with a study center

  • University of Alabama at Birmingham

    Birmingham, Alabama 35233
    United States

    Active - Recruiting

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