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NCT05758766Active, not recruiting

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

Source: ClinicalTrials.gov · Last updated 23 Jan 2026

Brief summary (registry, in English)

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

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
30 (estimated)
First submitted
14 Feb 2023
Start date
30 Aug 2023
Primary completion date
30 Dec 2026
Lead sponsor
University of Alabama at Birmingham
NCT number
NCT05758766

What you commit to

  • Study type: Interventional
  • Planned participants: 30
  • From 30 Aug 2023 to the primary completion date, 30 Dec 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Chronic transfusion therapy
  • PPI therapy

Other illness

  • Known allergy to FS

Age

  • Age less than 5 years
  • Age \> 18 years old

Other

  • Known to be pregnant
  • Breastfeeding mothers
  • Current use of antibiotics
  • Use of pre or probiotic supplements

Who the study is looking for

  • Diagnosis of sickle cell anemia HbSS or HbSB0 thal at steady state
  • Age 5-18 years old

Age in the registry: 5 years to 18 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Alabama at Birmingham
Coordinator of this site? Confirm its status
BirminghamUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.