Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2026-04-11 @ 2:45 PM
Study NCT ID:
NCT06555705
Status:
COMPLETED
Last Update Posted:
2025-03-07
First Post:
2024-08-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Omega 3 Supplementation on the Heart Rate Variability in Obese Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D063766', 'term': 'Pediatric Obesity'}], 'ancestors': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004281', 'term': 'Docosahexaenoic Acids'}], 'ancestors': [{'id': 'D015525', 'term': 'Fatty Acids, Omega-3'}, {'id': 'D004042', 'term': 'Dietary Fats, Unsaturated'}, {'id': 'D004041', 'term': 'Dietary Fats'}, {'id': 'D005223', 'term': 'Fats'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D005231', 'term': 'Fatty Acids, Unsaturated'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D005395', 'term': 'Fish Oils'}, {'id': 'D009821', 'term': 'Oils'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-04-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2024-09-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-06', 'studyFirstSubmitDate': '2024-08-11', 'studyFirstSubmitQcDate': '2024-08-14', 'lastUpdatePostDateStruct': {'date': '2025-03-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The effect of omega-3 on heart rate variability that is represented in the root mean square of successive differences of the heart rates ( RMSSD ) in obese children', 'timeFrame': '3 months', 'description': 'Obese children will be examined for the effect of Omega-3 supplementation on heat rate variability'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obesity, Childhood']}, 'descriptionModule': {'briefSummary': 'Evidence shows that omega-3 fatty acids lower blood triglyceride levels, lower blood pressure, enhance insulin sensitivity, and improve heart rate variability (HRV) measures, all of which may be indicators of cardiovascular health.As a result, omega-3 fatty acid supplementation may be a low-cost strategy with little adverse effects for obese youngsters, perhaps delaying the development of chronic cardiovascular illnesses.', 'detailedDescription': 'This is a two-armed study , the interventional group will be given omega 3 and the control group will be given a placebo and both will be examined for the heart rate variability'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children (5-12 years) whose parents or caregivers will agree to be enrolled in the study\n* Obese Children (Simple obesity )\n* Both males and females\n\nExclusion Criteria:\n\n* Patients are known to have cardiac disease\n* Patients with associated chronic systemic illness\n* Patients with 2ry obesity : (endocrine /metabolic/genetics/drug intake)\n* Patients on medications affecting heart rate :structural or arrhythmic'}, 'identificationModule': {'nctId': 'NCT06555705', 'briefTitle': 'Effect of Omega 3 Supplementation on the Heart Rate Variability in Obese Children', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Effect of Omega 3 Supplementation on the Heart Rate Variability in Obese Children, a Clinical Trial', 'orgStudyIdInfo': {'id': 'MS-547-2023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Interventional group recieveing omega 3 and the standard nutritional regimen for 3 months', 'description': 'The intervention group will be examined by 10 -minutes Holter and then omega 3 will be given to children( at least 400 mg eicosapentaenoic acid (EPA) and 120 mg docosahexaenoic acid (DHA) daily in addition to the standard nutritional regimen ) daily for 3 months and then reassesent of Holter will be carried out .', 'interventionNames': ['Dietary Supplement: Omega 3']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control group receiving placebo and the standard nutritional regimen for 3 months', 'description': 'The control group will be examined by 10 -minutes Holter and then the standard nutritional regimen will be given daily for 3 months and then reassessment of Holter will be carried out .', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Placebo', 'type': 'OTHER', 'description': 'The control group will be given placebo for 3 months', 'armGroupLabels': ['Control group receiving placebo and the standard nutritional regimen for 3 months']}, {'name': 'Omega 3', 'type': 'DIETARY_SUPPLEMENT', 'description': 'The interventional group will be given omega 3 for 3 months', 'armGroupLabels': ['Interventional group recieveing omega 3 and the standard nutritional regimen for 3 months']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Hoda Atef Abdelsattar Ibrahim', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Rodina Sobhy', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Professor of Pediatrics'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "Throughout the study, the privacy and confidentiality of the data will be perceived, the results will be presented anonymously without disclosure of patients' personal identifying information."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lectuere of Pediatrics and Pediatric Clinical Nutrition', 'investigatorFullName': 'Hoda Atef Abdelsattar Ibrahim', 'investigatorAffiliation': 'Cairo University'}}}}