Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-26 @ 12:04 AM
Study NCT ID:
NCT05186194
Status:
UNKNOWN
Last Update Posted:
2022-01-11
First Post:
2021-12-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Vitamin D and Calcium Supplementation on the Prevention of Stress Fractures.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015775', 'term': 'Fractures, Stress'}], 'ancestors': [{'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014807', 'term': 'Vitamin D'}, {'id': 'D002118', 'term': 'Calcium'}], 'ancestors': [{'id': 'D012632', 'term': 'Secosteroids'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'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': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 240}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-09-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2022-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-12-22', 'studyFirstSubmitDate': '2021-12-08', 'studyFirstSubmitQcDate': '2021-12-22', 'lastUpdatePostDateStruct': {'date': '2022-01-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Stress fracture', 'timeFrame': '3 months after the start of the basic military training.', 'description': 'Stress fractures were recorded when recruits reported to the clinic with suspected symptoms. All stress fractures were confirmed with radiography or Magnetic Resonance Imaging(MRI). Each subject with a stress fracture was recorded.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stress Fracture', 'Vitamin d']}, 'descriptionModule': {'briefSummary': 'The main objective of this study is to find whether supplemental vitamin d and calcium can reduce the incidence of stress fractures in recruits. These high-risk recruits undergo intensive training which elevated bone turnover, which requires adequate level of vitamin D and calcium in order to support bone health. It is hypothesized that supplemental vitamin d and calcium will decrease the occurrence of stress fractures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '25 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Recruits newly enlisted at a training base in September 2021.\n* Agree to accept relevant inspections and serological research, and sign an informed consent form.\n\nExclusion Criteria:\n\n* Suffer from diabetes, osteomyelitis and other diseases.\n* Suffer from claustrophobia and other MRI examination contraindications.\n* Long-term use of glucocorticoids, non-steroidal anti-inflammatory drugs or calcium, vitamin D.\n* A history of kidney disease.\n* Allergic to any ingredient of the medicine.'}, 'identificationModule': {'nctId': 'NCT05186194', 'briefTitle': 'The Effect of Vitamin D and Calcium Supplementation on the Prevention of Stress Fractures.', 'organization': {'class': 'OTHER', 'fullName': 'Xijing Hospital'}, 'officialTitle': 'The Effect of Vitamin D and Calcium Supplementation on the Prevention of Stress Fractures in Chinese Recruits.', 'orgStudyIdInfo': {'id': 'KY20212116-F-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental (Treatment) Group', 'description': 'Oral vitamin D1000IU, 1/day, calcium 1200mg, 1/day, for 8 weeks.', 'interventionNames': ['Drug: Vitamin D, Calcium']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control Group', 'description': 'Oral placebo, for 8 weeks.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Vitamin D, Calcium', 'type': 'DRUG', 'description': 'Vitamin D, calcium are available in tablets. During the 8 weeks of training, subjects were asked to take supplement tablets per day after dinner.', 'armGroupLabels': ['Experimental (Treatment) Group']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '710032', 'city': 'Xi’an', 'state': 'Shanxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'long bi, MD,PHD', 'role': 'CONTACT', 'email': 'bilong@fmmu.edu.cn', 'phone': '+86 02984773524'}], 'facility': 'Department of Orthopedics, Xijing Hospital, The Air Force Medical University', 'geoPoint': {'lat': 35.99785, 'lon': 113.52486}}], 'centralContacts': [{'name': 'long bi, MD,PHD', 'role': 'CONTACT', 'email': 'bilong@fmmu.edu.cn', 'phone': '+86 02984773524'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xijing Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}