Ignite Creation Date:
2025-12-25 @ 1:10 AM
Ignite Modification Date:
2025-12-25 @ 11:21 PM
Study NCT ID:
NCT06929793
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-04-16
First Post:
2025-04-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Multiple Micronutrients Supplementation on Angiogenesis and Vasculogenesis Factors, and Fetal Biometry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020567', 'term': 'Fetal Weight'}], 'ancestors': [{'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-15', 'studyFirstSubmitDate': '2025-04-08', 'studyFirstSubmitQcDate': '2025-04-15', 'lastUpdatePostDateStruct': {'date': '2025-04-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PlGF levels', 'timeFrame': 'It was carried out at gestational age: 1. Trimester 1: 8-14 weeks. 2. Trimester 2: 20-26 weeks.', 'description': 'Examination of angiogenesis factors in both research groups, using venous blood to measure Placental Growth Factor (PlGF) levels'}, {'measure': 'sFlt-1/PlGF ratio', 'timeFrame': '20-26 weeks of gestation', 'description': 'Examination of the balance of angiogenesis factors in both groups, using venous blood to measure the ratio of soluble fms-Like Tyrosine Kinase-1 to Placental Growth Factor (s-Flt-1/PlGF),'}, {'measure': 'mean pulsatility index of uterine artery', 'timeFrame': '1. Trimester 1 : 8-14 weeks. 2. Trimester 2 : 20-26 weeks.', 'description': 'Examination of vasculogenesis factors by measuring the mean Pulsatility Index of bilateral uterine arteries'}, {'measure': 'Head circumference', 'timeFrame': '20-26 weeks of gestation', 'description': 'Head circumference based on ultrasonography'}, {'measure': 'Femur length', 'timeFrame': '20-26 weeks of gestation', 'description': 'Femur length based on ultrasonography'}, {'measure': 'Estimated fetal weight', 'timeFrame': '20-26 weeks of gestation', 'description': 'Estimated fetal weight based on ultrasonography'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['micronutrients', 'angiogenesis', 'vasculogenesis', 'fetal biometry'], 'conditions': ['Angiogenesis', 'Fetal Weight', 'Pregnancy Related', 'Nutrient Element Deficiency', 'High Risk Pregnancy']}, 'descriptionModule': {'briefSummary': 'Multiple micronutrients play an important role during pregnancy, since the decidualization and implantation phases. It has an impact on placentation and remodeling of blood vessels. The optimal early pregnancy conditions accompanied by great angiogenesis and vasculogenesis factors will influence fetal growth. This study aims to determine the effect of maternal multiple micronutrient supplementation on angiogenesis factors, vasculogenesis factors, and fetal biometry. It is a clustered randomized controlled trial that aims to determine the impact of maternal micronutrient supplementation on PlGF levels, sFlt-1/PlGF ratio, mean pulsatility index of uterine artery, and fetal biometry (head circumference, femur length, and estimated fetal weight percentile). The target population for the study was all pregnant women who underwent antenatal check-ups at community health centers in DKI Jakarta.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'genderBased': True, 'genderDescription': 'Pregant women', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Pregnant women with gestation age 8 - 14 weeks.\n2. Singleton pregnancy.\n3. Living in DKI Jakarta.\n4. Can consume tablets or caplets.\n5. Willing to only consume the vitamins used in the research\n6. Willing to undergo antenatal examination at community health centers in DKI Jakarta.\n7. Willing to be a research subject by signing the research consent form.\n\nExclusion Criteria:\n\n1. Multiple pregnancies.\n2. Pregnancy with assisted reproduction.\n3. History of polycystic ovary syndrome.\n4. History of chronic hypertension.\n5. History of gestational diabetes mellitus.\n6. Diagnosed with type 2 diabetes mellitus.\n7. History of preeclampsia.\n8. Recurrent miscarriage (Recurrent Pregnancy Loss).\n9. Maternal medical conditions (Autoimmune; Heart Disease; Malignancy).\n10. History of chronic infection.\n11. Cannot consume tablets or caplets\n12. Planning to move out of DKI Jakarta before and/or not giving birth in DKI Jakarta.'}, 'identificationModule': {'nctId': 'NCT06929793', 'briefTitle': 'Multiple Micronutrients Supplementation on Angiogenesis and Vasculogenesis Factors, and Fetal Biometry', 'organization': {'class': 'OTHER', 'fullName': 'Dr Cipto Mangunkusumo General Hospital'}, 'officialTitle': 'Multiple Micronutrients Supplementation on Angiogenesis and Vasculogenesis Factors, and Fetal Biometry', 'orgStudyIdInfo': {'id': '24081311'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Intervention', 'description': '1. Multiple micronutrient\n2. Calcium Carbonat 766 mg\n3. Vitamin D3 5000 IU\n4. DHA 300 mg', 'interventionNames': ['Dietary Supplement: Multiple Micronutrients']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'Standard antenatal vitamins', 'interventionNames': ['Drug: Standard Antenatal Vitamin']}], 'interventions': [{'name': 'Multiple Micronutrients', 'type': 'DIETARY_SUPPLEMENT', 'description': '1. Multiple micronutrient\n2. Calcium Carbonat 766 mg\n3. Vitamin D3 5000 IU\n4. DHA 300 mg', 'armGroupLabels': ['Intervention']}, {'name': 'Standard Antenatal Vitamin', 'type': 'DRUG', 'description': 'Standard Antenatal Vitamin given in Community Health Centers', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10430', 'city': 'Jakarta Pusat', 'state': 'DKI Jakarta', 'country': 'Indonesia', 'facility': 'Maternal Fetal Medicine Division, Obstetric Gynecology Department Cipto Mangunkusumo General Hospital', 'geoPoint': {'lat': -6.1818, 'lon': 106.8223}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dr Cipto Mangunkusumo General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Amanda Rumondang', 'investigatorAffiliation': 'Dr Cipto Mangunkusumo General Hospital'}}}}