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NCT Number: NCT07530965

OMEGA-3-FATTY ACIDS IN CHILDREN WITH SICKLE CELL DISEASE

The purpose of this feasibility study is to investigate the role of a dietary supplement in modulating the gut microbiota and improving pain outcomes in children with sickle cell disease (SCD).

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Key information

Conditions

Sickle Cell Disease (SCD) Anemia Anemia, Hemolytic Anemia, Hemolytic, Congenital Anemia, Sickle Cell Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemoglobinopathies

Age range

5 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Sickle cell disease (SCD) is associated with significant morbidity and mortality. Acute pain is the most frequent cause of hospitalization in children. Pain in sickle cell disease is 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. Our preliminary study showed that gut dysbiosis is linked to pain.

Omega -3-fatty acids (fish oil) has been shown to improve pain outcomes in individuals with SCD. Acceptance of fish oil varies given its fishy smell and taste. Flaxseed is a plant-based omega-3-fatty acid which has antioxidant and anti-inflammatory properties.

This study aims to conduct a feasibility trial on the use of flaxseed to modulating the gut microbiome and improving inflammatory markers and pain outcomes in children with SCD.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Children 5-18 years with SCD at steady state. Steady state will be defined as not requiring an acute care visit for pain in the last 28 days.

Exclusion criteria

  • current use of antibiotics except prophylactic penicillin
  • current use of pre-or probiotic supplements
  • current use of PPI therapy
  • pregnant or lactating females
  • individuals with known allergy to Flaxseed

Treatment and study plan

Flaxseed

Dietary Supplement

Flaxseed

Primary outcomes

  1. Feasibility

    Time frame: 4 weeks

    Participants will be asked to complete electronic adherence dairies- Feasibility will be defined by more than 50% of enrolled participants eating flaxseed at least 5 days a week for the study duration

Secondary outcomes

  1. Pain

    Time frame: 4 weeks

    Patient reported pain outcomes will be assessed weekly with pain scores and end of the study with quality of life measures

Study contacts

Contact information is provided by the study sponsor or research team.

Chinenye R Dike, MD MS

CONTACT

[email protected]

205 638 9918

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Official study title

A Single Arm/ Open Label Feasibility Trial of Omega-3- Fatty Acids in Children With Sickle Cell Disease

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Apr 15, 2026
Registry last updated
Apr 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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