The University of Alabama at Birmingham is set to launch a new study to determine whether plant-based omega-3 fatty acids in place of fish oil omega-3 fatty acids are more acceptable to pediatric patients with sickle cell disease (SCD) and whether they improve outcomes among these individuals.
This interventional feasibility study will provide up to 24 participants with a diet rich in plant-based omega-3 fatty acids for 4 weeks vs a regular diet, with the aim of assessing whether the plant-based fatty acids are more acceptable than the fish oil version. Primary outcome measures include acute pain frequency as reported in pain diaries and reflected in acute care visits and chronic pain measured by a validated questionnaire.
The secondary outcome measure is inflammation over the 4-week period as measured by inflammatory biomarkers.
The study will be open to participants aged 5 to 18 years with a diagnosis of SCD. Those on chronic transfusion therapy or on proton pump inhibitor treatment will be excluded. The study is expected to start on May 14, 2023, and its expected primary completion date is January 30, 2024. The final study completion date is expected to be May 30, 2024.
Read more about SCD therapies
SCD is a group of rare, inherited blood disorders that cause a change in the shape and structure of hemoglobin, resulting in the early death of red blood cells and inadequate transport of oxygen to the body’s tissues. The sickle-shaped blood cells often obstruct small blood vessels, leading to acute and chronic pain and even stroke in some patients. Anemia and severe infections are also common.
SCD is also frequently associated with gut dysbiosis, which is driven in part by inflammatory processes. For some patients with SCD, omega-3 fatty acids in fish oil form have been shown to reduce pain and improve outcomes, but their acceptance has been variable.
Reference
Study on use of omega-3 fatty acids to improve outcomes in children with sickle cell disease. ClinicalTrials.gov. March 7, 2023. Updated March 21, 2023. Accessed March 23, 2023.
