Ignite Creation Date:
2025-12-24 @ 9:14 PM
Ignite Modification Date:
2026-01-04 @ 9:16 PM
Study NCT ID:
NCT01751204
Status:
COMPLETED
Last Update Posted:
2013-03-28
First Post:
2012-12-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Absorbability Between Calcium Tablet and Calcium Ion Water
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D002118', 'term': 'Calcium'}], 'ancestors': [{'id': 'D008673', 'term': 'Metals, Alkaline Earth'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D008670', 'term': 'Metals'}, {'id': 'D001779', 'term': 'Blood Coagulation Factors'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'completionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-03-26', 'studyFirstSubmitDate': '2012-12-13', 'studyFirstSubmitQcDate': '2012-12-13', 'lastUpdatePostDateStruct': {'date': '2013-03-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-12-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum calcium profile (including AUC, Cmax, and Tmax)', 'timeFrame': 'Overall 2 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the absorbability of calcium tablet and calcium ion water.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '55 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Postmenopausal females\n\nExclusion Criteria:\n\n* Taking medicines or functional food that affect serum calcium levels\n* Diseases that affect bone\n* Renal or hepatic dysfunction\n* Heart disease\n* Participation in any clinical trial within 90 days of the commencement of the trial'}, 'identificationModule': {'nctId': 'NCT01751204', 'briefTitle': 'Comparison of Absorbability Between Calcium Tablet and Calcium Ion Water', 'organization': {'class': 'OTHER', 'fullName': 'Hiroshima University'}, 'officialTitle': 'A Randomized, Double-blind, Crossover Study to Compare the Absorbability Between Calcium Tablet and Calcium Ion Water', 'orgStudyIdInfo': {'id': 'eki-677'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Calcium tablet', 'description': '250 mg calcium/tablet', 'interventionNames': ['Dietary Supplement: Calcium tablet']}, {'type': 'EXPERIMENTAL', 'label': 'Calcium ion water (250mg)', 'description': '250 mg calcium in 200 ml water', 'interventionNames': ['Dietary Supplement: Calcium ion water (250mg)']}, {'type': 'EXPERIMENTAL', 'label': 'Calcium ion water (125mg)', 'description': '125 mg calcium in 200 ml water', 'interventionNames': ['Dietary Supplement: Calcium ion water (125mg)']}], 'interventions': [{'name': 'Calcium tablet', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Calcium tablet']}, {'name': 'Calcium ion water (250mg)', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Calcium ion water (250mg)']}, {'name': 'Calcium ion water (125mg)', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Calcium ion water (125mg)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '734-8551', 'city': 'Hiroshima', 'country': 'Japan', 'facility': 'Hiroshima University', 'geoPoint': {'lat': 34.4, 'lon': 132.45}}], 'overallOfficials': [{'name': 'Fumiko Higashikawa, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hiroshima University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hiroshima University', 'class': 'OTHER'}, 'collaborators': [{'name': 'CHUGOKU KAYAKU CO., LTD.', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Fumiko Higashikawa', 'investigatorAffiliation': 'Hiroshima University'}}}}