Purpose

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

Condition

Eligibility

Eligible Ages
Between 5 Years and 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover Assignment
Intervention Model Description
Participants will cross over after a while on plant-based omega-3-FA.
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)
Masking Description
Both principal investigator and participants will be blinded to arm of study

Arm Groups

ArmDescriptionAssigned Intervention
No Intervention
Regular diet
Participants will continue their regular diet.
Experimental
Plant based omega 3 Fatty Acid
Participants ingest their regular diet supplemented with a plant-based omega-3-FA
  • Dietary Supplement: Plant-based omega-3-FA
    Plant-based omega 3 Fatty Acids

Recruiting Locations

University of Alabama at Birmingham
Birmingham, Alabama 35233
Contact:
Dike
205-638-9918
cdike@uabmc.edu

More Details

Status
Recruiting
Sponsor
University of Alabama at Birmingham

Study Contact

Dike
2056389918
cdike@uabmc.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.