Study on Use of Omega-3 Fatty Acids to Improve Outcomes in Individuals With Sickle Cell Disease
Purpose
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
Condition
- Sickle Cell Disease
Eligibility
- Eligible Ages
- Between 5 Years and 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover Assignment
- Intervention Model Description
- Participants will cross over after a while on plant-based omega-3-FA.
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
- Masking Description
- Both principal investigator and participants will be blinded to arm of study
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
No Intervention Regular diet |
Participants will continue their regular diet. |
|
|
Experimental Plant based omega 3 Fatty Acid |
Participants ingest their regular diet supplemented with a plant-based omega-3-FA |
|
Recruiting Locations
Birmingham, Alabama 35233
More Details
- Status
- Recruiting
- Sponsor
- University of Alabama at Birmingham
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.