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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Feasibility Study on the Use of Plant Based Omega-3-Fatty Acids (Flaxseed) to Improve Inflammation Driven Pain Outcomes in Children With Sickle Cell Anemia

Conditions
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Sickle Cell Disease

Intervention / Treatment
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* Dietary Supplement: Plant-based omega-3-FA


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Participants will cross over after a while on plant-based omega-3-FA.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Regular diet<br>Participants will continue their regular diet. | |
| Experimental: Plant based omega 3 Fatty Acid<br>Participants ingest their regular diet supplemented with a plant-based omega-3-FA | Dietary Supplement: Plant-based omega-3-FA<br>* Plant-based omega 3 Fatty Acids<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute pain | Decrease in acute pain frequency measured with weekly pain diaries and acute care visits for pain | 12 weeks | 
| Chronic pain | Improvement in quality of life measured using a validated questionnaire | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inflammation | Decrease in inflammation as measured by inflammatory markers | 12 weeks |