Ignite Creation Date:
2025-12-24 @ 10:36 PM
Ignite Modification Date:
2026-02-25 @ 8:59 PM
Study NCT ID:
NCT00575835
Status:
COMPLETED
Last Update Posted:
2008-01-08
First Post:
2007-12-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oral Vitamin D Supplementation in Elderly Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-12', 'completionDateStruct': {'date': '2007-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-12-26', 'studyFirstSubmitDate': '2007-12-17', 'studyFirstSubmitQcDate': '2007-12-17', 'lastUpdatePostDateStruct': {'date': '2008-01-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-12-18', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood 25 OH D vitamin concentrations', 'timeFrame': '8 times during the year'}], 'secondaryOutcomes': [{'measure': 'serum calcium, 24-hour calcium excretion in urine, creatinine clearance', 'timeFrame': '8 times during the year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['vitamin D', 'seasonal variation', 'PTH', 'bone markers'], 'conditions': ['Optimal Vitamin D Administration']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to compare oral vitamin D supplementation administered in two different ways, namely either twice a day (800IU/d, 292000IU/y) or three times a year (97333IU every 4 months, 292000IU/y) in elderly women in combination with daily supplementation of calcium 1 gram. We will 1)compare the blood concentrations of 25 OH vitamin D in the two treatment groups amd monitor if a sufficient and safe concentration of 25OH D in blood can be maintained with these two treatments.2) Find out seasonal variation in vitamin D concentrations in these treatments. 3) Find out safety of these treatments'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '70 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Females\n* 70-80 years\n* Living in the community\n\nExclusion Criteria:\n\n* Renal disease\n* Diseases that contraindicate vitamin D supplementation\n* Medications affecting bone\n* Malignancy'}, 'identificationModule': {'nctId': 'NCT00575835', 'briefTitle': 'Oral Vitamin D Supplementation in Elderly Women', 'organization': {'class': 'OTHER', 'fullName': 'University of Helsinki'}, 'officialTitle': 'Oral Vitamin D Supplementation in Elderly Women: Twice a Day or Three Times a Year? A Randomised Controlled Trial', 'orgStudyIdInfo': {'id': '77/2006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'interventionNames': ['Dietary Supplement: vitamin D twice daily']}, {'type': 'EXPERIMENTAL', 'label': '2', 'interventionNames': ['Dietary Supplement: Vitamin D3 oil three times in a year']}], 'interventions': [{'name': 'vitamin D twice daily', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Kalsipos-D, vitamin D3 400 ID/tbl, 2 tbl/day for one year', 'armGroupLabels': ['1']}, {'name': 'Vitamin D3 oil three times in a year', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Vigantol oil , D3 20000IU/ml, 4.9 ml every four months for one year', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00029 HUS', 'city': 'Helsinki', 'country': 'Finland', 'facility': 'Helsinki University Central Hospital, department of medicine, division of endocrinology', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Helsinki', 'class': 'OTHER'}, 'collaborators': [{'name': 'Päivikki and Sakari Sohlberg Foundation, Finland', 'class': 'OTHER'}, {'name': 'Lilly Foundation', 'class': 'UNKNOWN'}], 'responsibleParty': {'oldNameTitle': 'Matti Välimäki, MD, Ph.D', 'oldOrganization': 'Helsinki University Central Hospital, Department of Medicine, Division of Endocrinology'}}}}