search
Back to results

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

Primary Purpose

Sickle Cell Disease

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Plant-based omega-3-FA
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sickle Cell Disease

Eligibility Criteria

5 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama at BirminghamRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Regular diet

Plant based omega 3 Fatty Acid

Arm Description

Participants will continue their regular diet.

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

Outcomes

Primary Outcome Measures

Acute pain
Decrease in acute pain frequency measured with weekly pain diaries and acute care visits for pain
Chronic pain
Improvement in quality of life measured using a validated questionnaire

Secondary Outcome Measures

Inflammation
Decrease in inflammation as measured by inflammatory markers

Full Information

First Posted
February 14, 2023
Last Updated
September 1, 2023
Sponsor
University of Alabama at Birmingham
search

1. Study Identification

Unique Protocol Identification Number
NCT05758766
Brief Title
Study on Use of Omega-3 Fatty Acids to Improve Outcomes in Individuals With Sickle Cell Disease
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 30, 2023 (Actual)
Primary Completion Date
July 30, 2024 (Anticipated)
Study Completion Date
July 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sickle Cell Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Participants will cross over after a while on plant-based omega-3-FA.
Masking
ParticipantInvestigator
Masking Description
Both principal investigator and participants will be blinded to arm of study
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Regular diet
Arm Type
No Intervention
Arm Description
Participants will continue their regular diet.
Arm Title
Plant based omega 3 Fatty Acid
Arm Type
Experimental
Arm Description
Participants ingest their regular diet supplemented with a plant-based omega-3-FA
Intervention Type
Dietary Supplement
Intervention Name(s)
Plant-based omega-3-FA
Intervention Description
Plant-based omega 3 Fatty Acids
Primary Outcome Measure Information:
Title
Acute pain
Description
Decrease in acute pain frequency measured with weekly pain diaries and acute care visits for pain
Time Frame
12 weeks
Title
Chronic pain
Description
Improvement in quality of life measured using a validated questionnaire
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Inflammation
Description
Decrease in inflammation as measured by inflammatory markers
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dike
Phone
2056389918
Email
cdike@uabmc.edu
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dike
Phone
205-638-9918
Email
cdike@uabmc.edu

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
It is not yet known if there will be a plan to make IPD available.

Learn more about this trial

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

We'll reach out to this number within 24 hrs