Ignite Creation Date:
2025-12-24 @ 2:42 PM
Ignite Modification Date:
2026-01-19 @ 9:04 PM
Study NCT ID:
NCT07298759
Status:
RECRUITING
Last Update Posted:
2025-12-23
First Post:
2025-07-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Hydroxytyrosol Administration on Superoxide Dismutase, Pulsatility Index and Resistance Index of Uterine Artery Doppler and Flow-Mediated Dilatation of Brachial Artery In Mothers With Hypertension In Pregnancy: A Randomized Double Blind Controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D046110', 'term': 'Hypertension, Pregnancy-Induced'}], 'ancestors': [{'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C005975', 'term': '3,4-dihydroxyphenylethanol'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'This study uses identical capsules for hydroxytyrosol and placebo to maintain masking of all parties.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 52}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-06-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-09', 'studyFirstSubmitDate': '2025-07-24', 'studyFirstSubmitQcDate': '2025-12-09', 'lastUpdatePostDateStruct': {'date': '2025-12-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in superoxide dismutase (SOD) from baseline to week 4.', 'timeFrame': 'Baseline and Week 4', 'description': 'To evaluate the anti-inflammatory effect of hydroxytyrosol supplementation by comparing the change in superoxide dismutase (SOD) between the hydroxytyrosol and placebo groups after 4 weeks.'}, {'measure': 'Change in Pulsatility Index (PI) of the uterine artery Doppler from baseline to week 4.', 'timeFrame': 'Baseline and Week 4', 'description': 'To evaluate the anti-inflammatory effect of hydroxytyrosol supplementation by comparing the change Pulsatility Index (PI) of the uterine artery Doppler between the hydroxytyrosol and placebo groups after 4 weeks.'}, {'measure': 'Change in Resistance Index (RI) of the uterine artery Doppler from baseline to week 4.', 'timeFrame': 'Baseline and Week 4', 'description': 'To evaluate the anti-inflammatory effect of hydroxytyrosol supplementation by comparing the change Resistance Index (RI) of the uterine artery Doppler between the hydroxytyrosol and placebo groups after 4 weeks.'}, {'measure': 'Change in flow-mediated dilation (FMD) of brachial artery from baseline to week 4.', 'timeFrame': 'Baseline and Week 4', 'description': 'To evaluate the anti-inflammatory effect of hydroxytyrosol supplementation by comparing the change in flow-mediated dilation (FMD) of brachial artery between the hydroxytyrosol and placebo groups after 4 weeks.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hydroxytyrosol'], 'conditions': ['Hypertension in Pregnancy']}, 'descriptionModule': {'briefSummary': 'The purpose of this clinical trial is to evaluate the effect of hydroxytyrosol 10 mg/day administered for 4 weeks in pregnant individuals with hypertension. This study will assess whether hydroxytyrosol increases serum superoxide dismutase levels, reduces uterine artery Doppler pulsatility and resistance indices, and improves brachial artery flow-mediated dilation.\n\nParticipants will be randomly assigned to receive either hydroxytyrosol or a matching placebo. Both products will be visually identical to ensure blinding. Participants will take two capsules daily for 4 weeks and attend two study visits for assessments and follow-up.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '20 Years', 'genderBased': True, 'genderDescription': 'Female', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Singleton pregnancy with a live intrauterine fetus, 20-35 years old\n2. Gestational age over 24 weeks. Gestational age is confirmed based on:\n\n * Last Menstrual Period (LMP)\n * First trimester ultrasound biometry\n3. Belongs to the Hypertensive Disorders of Pregnancy group, with the following criteria:\n\n * Gestational hypertension and preeclampsia according to ACOG 2018 criteria\n * Chronic hypertension according to ACOG 2019 criteria\n * Superimposed preeclampsia according to ACOG 2018 criteria\n\nExclusion Criteria:\n\n1. Pregnancy with infection, including chronic infections such as tuberculosis (TB), HIV, or hepatitis B\n2. Pregnancy with other complications (e.g., diabetes mellitus, heart disease, kidney disease, liver disease, malignancy, autoimmune disorders)\n3. Refusal to participate in the study'}, 'identificationModule': {'nctId': 'NCT07298759', 'acronym': 'HYDROXY-2', 'briefTitle': 'The Effect of Hydroxytyrosol Administration on Superoxide Dismutase, Pulsatility Index and Resistance Index of Uterine Artery Doppler and Flow-Mediated Dilatation of Brachial Artery In Mothers With Hypertension In Pregnancy: A Randomized Double Blind Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'Dr Cipto Mangunkusumo General Hospital'}, 'officialTitle': 'The Effect of Hydroxytyrosol Administration on Superoxide Dismutase, Pulsatility Index and Resistance Index of Uterine Artery Doppler and Flow-Mediated Dilatation of Brachial Artery In Mothers With Hypertension In Pregnancy: A Randomized Double Blind Controlled Trial', 'orgStudyIdInfo': {'id': '25-03-0305'}, 'secondaryIdInfos': [{'id': 'Cipto Mangunkusumo Hospital', 'type': 'OTHER', 'domain': 'Cipto Mangunkusumo Hospital, RSCM Jakarta'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Group', 'description': 'Participants in this arm will receive a placebo capsule orally twice daily for 4 weeks, alongside standard antenatal care. The placebo is visually identical to the hydroxytyrosol supplement to maintain masking.', 'interventionNames': ['Dietary Supplement: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Hydroxytyrosol Group', 'description': 'Participants in this arm will receive hydroxytyrosol 10 mg orally twice daily for 4 weeks, alongside standard antenatal care.', 'interventionNames': ['Dietary Supplement: Hydroxytyrosol']}], 'interventions': [{'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Placebo oral capsule identical in appearance to hydroxytyrosol supplement, administered twice daily for 4 weeks.', 'armGroupLabels': ['Placebo Group']}, {'name': 'Hydroxytyrosol', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Hydroxytyrosol is a natural polyphenol with antioxidant and anti-inflammatory properties, derived from olives. In this study, hydroxytyrosol 10 mg will be administered orally twice daily for 4 weeks to assess its effects on blood pressure and inflammatory biomarkers in hypertensive pregnant women.', 'armGroupLabels': ['Hydroxytyrosol Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10430', 'city': 'Jakarta', 'state': 'Jakarta Special Capital Region', 'status': 'RECRUITING', 'country': 'Indonesia', 'contacts': [{'name': 'Intje Sheila Dahlan, dr., Sp.OG', 'role': 'CONTACT', 'email': 'sheilladahlan@gmail.com', 'phone': '+628114355677'}], 'facility': 'Dr. Cipto Mangunkusumo National Central Public Hospital', 'geoPoint': {'lat': -6.21462, 'lon': 106.84513}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dr Cipto Mangunkusumo General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant Maternal-Fetal Medicine Specialist, Obstetrician-Gynecologist and Principal Investigator', 'investigatorFullName': 'Damar Prasmusinto', 'investigatorAffiliation': 'Dr Cipto Mangunkusumo General Hospital'}}}}