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

April 8, 2026 updated by: Chinenye Dike, University of Alabama at Birmingham

A Single Arm/ Open Label Feasibility Trial of 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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Chinenye R Dike, MD MS
  • Phone Number: 205 638 9918
  • Email: cdike@uabmc.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Flaxseed
Dietary supplement: Flaxseed
Flaxseed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

March 16, 2026

First Submitted That Met QC Criteria

April 8, 2026

First Posted (Actual)

April 15, 2026

Study Record Updates

Last Update Posted (Actual)

April 15, 2026

Last Update Submitted That Met QC Criteria

April 8, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-300016247
  • UAB (Other Identifier: UAB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Sickle Cell Disease (SCD)

Clinical Trials on Flaxseed

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Slovakia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe