Ignite Creation Date:
2025-12-24 @ 4:41 PM
Ignite Modification Date:
2026-03-05 @ 11:54 AM
Study NCT ID:
NCT02809066
Status:
COMPLETED
Last Update Posted:
2016-06-22
First Post:
2016-06-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dietary Calcium Intake in Premenstrual Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011293', 'term': 'Premenstrual Syndrome'}], 'ancestors': [{'id': 'D008599', 'term': 'Menstruation Disturbances'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-06-21', 'studyFirstSubmitDate': '2016-06-16', 'studyFirstSubmitQcDate': '2016-06-21', 'lastUpdatePostDateStruct': {'date': '2016-06-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-06-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Premenstrual Syndrome Scale (PMSS)', 'timeFrame': 'Eight weeks', 'description': 'Premenstrual Syndrome Scale (PMSS) was used for symptom assessment at initial and after two menstrual cycles.'}], 'secondaryOutcomes': [{'measure': 'Change in Quality of life scale Short Form (SF-36)', 'timeFrame': 'Eight weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['premenstrual syndrome', 'calcium', 'quality of life'], 'conditions': ['Premenstrual Syndrome']}, 'descriptionModule': {'briefSummary': 'This study was planned and conducted to investigate effect of adequate calcium intake on Premenstrual Syndrome (PMS) symptoms in women with PMS who have inadequate calcium intake.', 'detailedDescription': 'This study was planned and conducted to investigate effect of adequate calcium intake on Premenstrual Syndrome (PMS) symptoms in women with PMS who have inadequate calcium intake. Thirty one women, aged between 20-28 years, diagnosed with PMS and suitable for inclusion criteria, were participated in study. Participants were allocated to intervention (n=16) and control (n=15) groups randomly.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '28 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nWomen with;\n\n* PMS who have inadequate calcium intake\n* Regular menstrual cycle\n* Menstrual flow which occurs every 22 to 35 days and last three to eight days\n\nExclusion Criteria:\n\n* Having any of metabolic diseases\n* Use oral contraceptive pill\n* user vitamins and minerals supplements\n* being smoker'}, 'identificationModule': {'nctId': 'NCT02809066', 'briefTitle': 'Dietary Calcium Intake in Premenstrual Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Eastern Mediterranean University'}, 'officialTitle': 'Effect of Sufficient Dietary Calcium Intake in Women With Premenstrual Syndrome', 'orgStudyIdInfo': {'id': '2015/10-03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Interventional group', 'description': '8-week follow- up with dietary sufficient calcium intake', 'interventionNames': ['Other: Sufficient dietary calcium intake in premenstrual syndrome']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': '8-week follow- up with no specific diet'}], 'interventions': [{'name': 'Sufficient dietary calcium intake in premenstrual syndrome', 'type': 'OTHER', 'description': 'Intervention group was ensured to take at least 1000 mg calcium from foods, 700-800 mg of it from dairy and dairy products, according to Recommended Dietary Allowances (RDA), for two months. These foods were;\n\n* 50 gr kashkaval cheese,\n* 400 ml milk and\n* 150 gr yogurt for each day.', 'armGroupLabels': ['Interventional group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Mersin', 'country': 'Turkey (Türkiye)', 'facility': 'Eastern Mediterranean University', 'geoPoint': {'lat': 36.81196, 'lon': 34.63886}}], 'overallOfficials': [{'name': 'Merve Yurt, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Eastern Mediterranean University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eastern Mediterranean University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Instructor', 'investigatorFullName': 'Merve YURT', 'investigatorAffiliation': 'Eastern Mediterranean University'}}}}