Using plant-based omega-3 fatty acids to improve outcomes in sickle cell disease
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
This study is testing if a diet high in plant-based omega-3 fatty acids can help kids and teens with sickle cell disease feel less pain and improve their health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 5 Years to 18 Years |
| Sex | All |
| Sponsor | University of Alabama at Birmingham Academic / other |
| Locations | 1 site (Birmingham, Alabama) |
| Trial ID | NCT05758766 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of a diet rich in plant-based omega-3 fatty acids on individuals aged 5-18 years with sickle cell disease. Participants will be randomized to receive either the omega-3-rich diet or a regular diet for 12 weeks, followed by a crossover after a 4-week washout period. The study aims to assess patient-reported pain outcomes and changes in inflammation markers associated with the dietary intervention. The goal is to determine if plant-based omega-3 fatty acids are more acceptable and effective in improving health outcomes for these patients.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 5-18 years diagnosed with sickle cell anemia HbSS or HbSB0 thal at steady state.
Not a fit: Patients who are older than 18 years, currently on chronic transfusion therapy, or have known allergies to fish oil will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a dietary intervention that significantly reduces pain and inflammation in individuals with sickle cell disease.
How similar studies have performed: Other studies have shown promising results with omega-3 fatty acids in managing pain in sickle cell disease, suggesting this approach may be beneficial.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Birmingham, Alabama
- University of Alabama at Birmingham — Birmingham, Alabama, United States (Recruiting)
Study contacts
- Study coordinator: Dike
- Email: cdike@uabmc.edu
- Phone: 2056389918
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.