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

Sickle Cell Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05758766
• Other study ID #: IRB-300010261
• Secondary ID: K23HL173704
• Status: Recruiting
• Phase: N/A
• Start date: August 30, 2023
• Est. completion date: December 30, 2025

Study information

• Verified date: June 2024
• Source: University of Alabama at Birmingham
• Contact: Dike
• Phone: 2056389918
• Email: cdike[@]uabmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 30, 2025
• Est. primary completion date: December 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Sickle Cell Disease

Intervention

Dietary Supplement:
• Plant-based omega-3-FA
Plant-based omega 3 Fatty Acids

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute pain	Decrease in acute pain frequency measured with weekly pain diaries and acute care visits for pain	12 weeks
Primary	Chronic pain	Improvement in quality of life measured using a validated questionnaire	12 weeks
Secondary	Inflammation	Decrease in inflammation as measured by inflammatory markers	12 weeks