Ignite Creation Date:
2025-12-24 @ 4:07 PM
Ignite Modification Date:
2025-12-24 @ 4:07 PM
Study NCT ID:
NCT05758766
Status:
RECRUITING
Last Update Posted:
2025-02-19
First Post:
2023-02-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study on Use of Omega-3 Fatty Acids to Improve Outcomes in Individuals With Sickle Cell Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000755', 'term': 'Anemia, Sickle Cell'}], 'ancestors': [{'id': 'D000745', 'term': 'Anemia, Hemolytic, Congenital'}, {'id': 'D000743', 'term': 'Anemia, Hemolytic'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006453', 'term': 'Hemoglobinopathies'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Both principal investigator and participants will be blinded to arm of study'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Participants will cross over after a while on plant-based omega-3-FA.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-08-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2026-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-14', 'studyFirstSubmitDate': '2023-02-14', 'studyFirstSubmitQcDate': '2023-03-06', 'lastUpdatePostDateStruct': {'date': '2025-02-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acute pain', 'timeFrame': '12 weeks', 'description': 'Decrease in acute pain frequency measured with weekly pain diaries and acute care visits for pain'}, {'measure': 'Chronic pain', 'timeFrame': '12 weeks', 'description': 'Improvement in quality of life measured using a validated questionnaire'}], 'secondaryOutcomes': [{'measure': 'Inflammation', 'timeFrame': '12 weeks', 'description': 'Decrease in inflammation as measured by inflammatory markers'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sickle Cell Disease']}, 'descriptionModule': {'briefSummary': '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', 'detailedDescription': '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.\n\nChildren 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of sickle cell anemia HbSS or HbSB0 thal at steady state\n* Age 5-18 years old\n\nExclusion Criteria:\n\n* Age less than 5 years\n* Age \\> 18 years old\n* Chronic transfusion therapy\n* Known to be pregnant\n* Breastfeeding mothers\n* Current use of antibiotics\n* Use of pre or probiotic supplements\n* PPI therapy\n* Known allergy to FS'}, 'identificationModule': {'nctId': 'NCT05758766', 'briefTitle': 'Study on Use of Omega-3 Fatty Acids to Improve Outcomes in Individuals With Sickle Cell Disease', 'organization': {'class': 'OTHER', 'fullName': 'University of Alabama at Birmingham'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'IRB-300010261'}, 'secondaryIdInfos': [{'id': 'K23HL173704', 'link': 'https://reporter.nih.gov/quickSearch/K23HL173704', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Regular diet', 'description': 'Participants will continue their regular diet.'}, {'type': 'EXPERIMENTAL', 'label': 'Plant based omega 3 Fatty Acid', 'description': 'Participants ingest their regular diet supplemented with a plant-based omega-3-FA', 'interventionNames': ['Dietary Supplement: Plant-based omega-3-FA']}], 'interventions': [{'name': 'Plant-based omega-3-FA', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Plant-based omega 3 Fatty Acids', 'armGroupLabels': ['Plant based omega 3 Fatty Acid']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Dike', 'role': 'CONTACT', 'email': 'cdike@uabmc.edu', 'phone': '205-638-9918'}], 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}], 'centralContacts': [{'name': 'Dike', 'role': 'CONTACT', 'email': 'cdike@uabmc.edu', 'phone': '2056389918'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'It is not yet known if there will be a plan to make IPD available.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alabama at Birmingham', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Pediatrics, Division of Pediatric Gastroenterology, Hepatology and Nutrition', 'investigatorFullName': 'Chinenye Dike', 'investigatorAffiliation': 'University of Alabama at Birmingham'}}}}