Ignite Creation Date:
2025-12-24 @ 3:43 PM
Ignite Modification Date:
2025-12-27 @ 8:07 AM
Study NCT ID:
NCT04255992
Status:
COMPLETED
Last Update Posted:
2020-02-05
First Post:
2020-02-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Short Term Cardiovascular Effects and Oxidative Status of Calcium and Vitamin D Supplementation of Postmenopausal Hypertensive Blacks Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D064030', 'term': 'S100 Calcium Binding Protein G'}], 'ancestors': [{'id': 'D064026', 'term': 'Calbindins'}, {'id': 'D002135', 'term': 'Calcium-Binding Proteins'}, {'id': 'D002352', 'term': 'Carrier Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009418', 'term': 'S100 Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'The double-blind model is applied to the study. Only the adjudicator, responsible for the distribution of medication knew the different regimes. Calcium and Vitamin D/Calcium were packaged in boxes of identical appearance and labeled for each participant by name and number of the randomization program. The randomization and packaging of the drugs was done by an investigator who had no clinical involvement.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This study is a double blind, randomized, controlled parallel clinical trial conducted at the Yaounde central hospital, Cameroon'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2019-05-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-03', 'studyFirstSubmitDate': '2020-02-03', 'studyFirstSubmitQcDate': '2020-02-03', 'lastUpdatePostDateStruct': {'date': '2020-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in serum concentration of anti-oxidant markers: Ferric reducing antioxidant Power (micromol)', 'timeFrame': '8 weeks', 'description': 'Change in concentration of anti oxidant marker from baseline to week 8. By spectrophotometer'}], 'primaryOutcomes': [{'measure': 'Change in nycthemeral blood pressure profile (mmHg)', 'timeFrame': '8 weeks', 'description': 'Change in nycthemeral blood pressure profile from baseline to week 08. By using Arterial Blood Pressure Monitoring.'}], 'secondaryOutcomes': [{'measure': 'Change in serum concentration of oxidant marker: malondialdehyde (micromol/l)', 'timeFrame': '8 weeks', 'description': 'Change in concentration of oxidant marker from baseline to week 8. By spectrophotometer'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Blood pressure', 'Oxidative status'], 'conditions': ['Hypertension', 'Postmenopausal Disorder']}, 'descriptionModule': {'briefSummary': 'This study aims to determine the effect of calcium and vitamin D supplementation on oxidative status and blood pressure profile of postmenopausal patients with high blood pressure in Yaoundé, Cameroon.\n\nThis study is a double-arm, double-blind, randomized and parallel clinical trial conducted at the Yaoundé Central Hospital', 'detailedDescription': 'Aim: to determine and compare the short term effect of calcium and vitamin D supplementation on oxidative status and blood pressure profile of postmenopausal patients with high blood pressure in Yaoundé, Cameroon.\n\nMethod: A double-arm, double-blind, randomized and parallel clinical trial conducted at the Yaoundé Central Hospital. Postmenopausal hypertensive blacks women who are taking taking antihypertensives drugs since 12 months,without diabetes mellitus or any inflammatory disease or hypercalcemia, are randomize into 2 groups. Depending on the group, the intervention consisted of the administration of Calcium 1000 mg daily or Vitamin D/Calcium 1000 mg/800 UI daily for 08 weeks. The endpoints were the nycthemeral blood pressure profile, pro oxidant marker (malondialdehyde) and anti-oxidant marker (Ferric reducing antioxidant).\n\nProgress: Recruitment for this study was completed in May 2019 with 22 patients.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '30 Years', 'genderBased': True, 'genderDescription': 'Postmenopausal hypertensive women', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Post menopausal hypertensive women since 12 months\n* On a stable antihypertensive therapies (determined by the investigator) for at least 3 months with no classes changes.\n* Before any study-specific procedure, the appropriate written informed consent must be obtained.\n\nExclusion Criteria:\n\n* Diabetes mellitus or inflammatory diseases\n* Hypercalcemia,\n* Side effects affecting life quality of patients (determined by the Data Safety Monitoring Board).\n* Withdrawal of consent'}, 'identificationModule': {'nctId': 'NCT04255992', 'briefTitle': 'Short Term Cardiovascular Effects and Oxidative Status of Calcium and Vitamin D Supplementation of Postmenopausal Hypertensive Blacks Women', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Yaounde Central Hospital'}, 'officialTitle': 'Short Term Cardiovascular Effects and Oxidative Status of Calcium and Vitamin D Supplementation of Postmenopausal Hypertensive Blacks Women in Sub Saharan Africa', 'orgStudyIdInfo': {'id': 'calcium and vitamin D in HW'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Calcium arm', 'description': '1000 mg Calcium tablet per day at 8am (+/- 1 hour) was add to the usual treatment for each patient. Patients are followed-up for a period of 08 weeks.', 'interventionNames': ['Dietary Supplement: Calcium Arm']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Vitamin D/Calcium', 'description': '1000 mg/800UI of VitaminD/Calcium tablet per day at 8am (+/- 1 hour) was add to the usual treatment for each patient. Patients are followed-up for a period of 08 weeks.', 'interventionNames': ['Dietary Supplement: Vitamin D/Calcium']}], 'interventions': [{'name': 'Calcium Arm', 'type': 'DIETARY_SUPPLEMENT', 'description': '1000 mg Calcium tablet / day will be added to the usual treatment for each patient for a period of 8 weeks.', 'armGroupLabels': ['Calcium arm']}, {'name': 'Vitamin D/Calcium', 'type': 'DIETARY_SUPPLEMENT', 'description': '1000 mg/800UI of the association Vitamin D/Calcium tablet / day will be added to the usual treatment for each patient for a period of 8 weeks.', 'armGroupLabels': ['Vitamin D/Calcium']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Yaoundé', 'country': 'Cameroon', 'facility': 'Yaounde Central Hospital, Cardiology department', 'geoPoint': {'lat': 3.86667, 'lon': 11.51667}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yaounde Central Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr, Principal investigator', 'investigatorFullName': 'CN NGANOU-GNINDJIO, MD, MSc', 'investigatorAffiliation': 'Yaounde Central Hospital'}}}}