Sickle Cell Disease
Conditions
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.
Interventions
DIETARY_SUPPLEMENTPlant-based omega-3-FA
Plant-based omega 3 Fatty Acids
Sponsors
University of Alabama at Birmingham
National Heart, Lung, and Blood Institute (NHLBI)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Both principal investigator and participants will be blinded to arm of study
Intervention model description
Participants will cross over after a while on plant-based omega-3-FA.
Eligibility
Sex/Gender
ALL
Age
5 Years to 18 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acute pain | 12 weeks | Decrease in acute pain frequency measured with weekly pain diaries and acute care visits for pain |
| Chronic pain | 12 weeks | Improvement in quality of life measured using a validated questionnaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Inflammation | 12 weeks | Decrease in inflammation as measured by inflammatory markers |
Countries
United States
Outcome results
None listed