Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2025-12-30 @ 4:05 AM
Study NCT ID:
NCT03898934
Status:
COMPLETED
Last Update Posted:
2022-05-05
First Post:
2019-03-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vitamin D Supplementation in PCOS Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014807', 'term': 'Vitamin D'}], 'ancestors': [{'id': 'D012632', 'term': 'Secosteroids'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER'], 'maskingDescription': 'Both patients and gynecologists were binded'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The 2 groups will be treated at the same time'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 170}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-30', 'studyFirstSubmitDate': '2019-03-30', 'studyFirstSubmitQcDate': '2019-04-01', 'lastUpdatePostDateStruct': {'date': '2022-05-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ovulation rate', 'timeFrame': '3 months', 'description': 'Number of mature follicles obtained'}, {'measure': 'Pregnancy rate', 'timeFrame': '3 months', 'description': 'Number of patients who get pregnant'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PCOS', 'Vitamin D', 'Supplementation', 'Ovulation', 'Pregnancy'], 'conditions': ['PCOS']}, 'descriptionModule': {'briefSummary': 'To assess whether Vitamin D supplementations for patients with polycystic ovary syndrome in conjunction with clomiphene citrate are beneficial or not', 'detailedDescription': 'This study is double blinded randomized controlled study conducted at Tanta University hospitals in the period from April 2019 to March 2022. Patients and methods: One hundred twelve patients were recruited and randomly allocated into 2 groups; study group with Vitamin D supplementation and control group without Vitamin D supplementation.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* PCOS\n* Infertile\n* Vitamin D deficient\n\nExclusion Criteria:\n\n* Age less than 20 and more than 35\n* Non PCOS patients\n* Obese patients\n* Previous ovarian surgery\n* Previous oophrectomy of one ovary'}, 'identificationModule': {'nctId': 'NCT03898934', 'acronym': 'PCOvit-D', 'briefTitle': 'Vitamin D Supplementation in PCOS Patients', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Dose Vitamin-D Supplementation Affect Reproductive Outcomes in Patients With Polycystic Ovary Syndrome?', 'orgStudyIdInfo': {'id': 'PCOvit-D'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vitamin D group', 'description': 'These patients will receive 6000IU daily for 8 weeks then 2000IU maintenance till pregnancy or end of study', 'interventionNames': ['Drug: Vitamin D']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo group', 'description': 'These group will receive placebo for the same periods of study group', 'interventionNames': ['Drug: Placebo Oral Tablet']}], 'interventions': [{'name': 'Vitamin D', 'type': 'DRUG', 'description': 'receive 6000iu daily for 8 weeks', 'armGroupLabels': ['Vitamin D group']}, {'name': 'Placebo Oral Tablet', 'type': 'DRUG', 'description': 'placebo for the same period', 'armGroupLabels': ['Placebo group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31111', 'city': 'Tanta', 'state': 'Algharbia', 'country': 'Egypt', 'facility': 'Ayman Shehata Dawood', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': '3 months', 'ipdSharing': 'YES', 'description': 'The investigators will share results'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer', 'investigatorFullName': 'Ayman S Dawood, MD', 'investigatorAffiliation': 'Tanta University'}}}}