Study on Use of Omega-3 Fatty Acids to Improve Outcomes in Individuals With Sickle Cell Disease
- Conditions
- Sickle Cell Disease
- Interventions
- Dietary Supplement: Plant-based omega-3-FA
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 30
- Diagnosis of sickle cell anemia HbSS or HbSB0 thal at steady state
- Age 5-18 years old
- 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
- Arm && Interventions
Group Intervention Description Plant based omega 3 Fatty Acid Plant-based omega-3-FA Participants ingest their regular diet supplemented with a plant-based omega-3-FA
- Primary Outcome Measures
Name Time Method Chronic pain 12 weeks Improvement in quality of life measured using a validated questionnaire
Acute pain 12 weeks Decrease in acute pain frequency measured with weekly pain diaries and acute care visits for pain
- 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