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

NCT ID: NCT05758766

Last Updated: 2026-01-23

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-30
• Study Completion Date: 2026-12-30

Brief 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

Detailed 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.

Conditions

Sickle Cell Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Regular diet

Participants will continue their regular diet.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Plant based omega 3 Fatty Acid

Participants ingest their regular diet supplemented with a plant-based omega-3-FA

Group Type: EXPERIMENTAL

Plant-based omega-3-FA

Intervention Type: DIETARY_SUPPLEMENT

Plant-based omega 3 Fatty Acids

Interventions

Plant-based omega-3-FA

Plant-based omega 3 Fatty Acids

Intervention Type: DIETARY_SUPPLEMENT

Eligibility 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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Chinenye Dike

Assistant Professor of Pediatrics, Division of Pediatric Gastroenterology, Hepatology and Nutrition

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

Countries

United States

Other Identifiers

K23HL173704

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB-300010261

Identifier Type: -

Identifier Source: org_study_id