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

NCT05758766 | Active Not Recruiting

• 2 other identifiers: IRB-300010261K23HL173704
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Sickle Cell Disease

Outcome Measures

Primary Outcomes (2)

• Acute pain

  Decrease in acute pain frequency measured with weekly pain diaries and acute care visits for pain

  12 weeks

• Chronic pain

  Improvement in quality of life measured using a validated questionnaire

  12 weeks

Secondary Outcomes (1)

• Inflammation

  12 weeks

Study Arms (2)

Regular diet

NO INTERVENTION

Participants will continue their regular diet.

Plant based omega 3 Fatty Acid

EXPERIMENTAL

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

Dietary Supplement: Plant-based omega-3-FA

Interventions

Plant-based omega-3-FA DIETARY_SUPPLEMENT

Plant-based omega 3 Fatty Acids

Plant based omega 3 Fatty Acid

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

MeSH Terms

Conditions

Anemia, Sickle Cell

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Both principal investigator and participants will be blinded to arm of study
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics, Division of Pediatric Gastroenterology, Hepatology and Nutrition

Model Details: Participants will cross over after a while on plant-based omega-3-FA.

Study Record Dates

• First Submitted: February 14, 2023
• First Posted: March 7, 2023
• Study Start: August 30, 2023
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: January 23, 2026

Record last verified: 2026-01

Locations

US (1)