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

Sponsor
University of Alabama at Birmingham (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05758766
Collaborator
(none)
40
Enrollment
2
Arms
13.5
Anticipated Duration (Months)

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Plant-based omega-3-FA
 N/A

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 8-12 weeks. We will compare outcomes (including patient reported pain outcomes and improvement in mean hemoglobin concentration) while on the omega-3 fatty acid rich diet

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
Participants will cross over after a while on plant-based omega-3-FA.Participants will cross over after a while on plant-based omega-3-FA.
Masking:
Single (Participant)
Masking Description:
Participants will be blinded to the dietary arm; regular diet versus plant-based omega 3-FA arm.
Primary Purpose:
Treatment
Official Title:
A Feasibility Study on the Use of Plant Based Omega-3-Fatty Acids to Improve Inflammation Driven Outcomes in Sickle Cell Disease
Anticipated Study Start Date :
Apr 14, 2023
Anticipated Primary Completion Date :
Jan 30, 2024
Anticipated Study Completion Date :
May 30, 2024

Arms and Interventions

Arm Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

  1. Acute pain [12 weeks]

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

  2. Chronic pain [12 weeks]

    Improvement in quality of life measured using a validated questionnaire

Secondary Outcome Measures

  1. Anemia [12 weeks]

    Improvement in mean hemoglobin concentration

  2. Inflammation [12 weeks]

    Decrease in inflammation as measured by inflammatory markers

Eligibility Criteria

Criteria

Ages Eligible for Study:
5 Years to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Diagnosis of sickle cell disease

  • Age 5-18 years old

Exclusion Criteria:

  • Age less than 5 years

  • Age > 18 years old

  • Chronic transfusion therapy

  • Known pregnancy status

  • Breastfeeding mothers

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of Alabama at Birmingham

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Chinenye Dike, Assistant Professor of Pediatrics, Division of Pediatric Gastroenterology, Hepatology and Nutrition, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT05758766
Other Study ID Numbers:
  • IRB-300010261
First Posted:
Mar 7, 2023
Last Update Posted:
Mar 7, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Anemia, Sickle Cell

Study Results

No Results Posted as of Mar 7, 2023