Ignite Creation Date:
2025-12-24 @ 2:22 PM
Ignite Modification Date:
2026-01-01 @ 8:24 AM
Study NCT ID:
NCT00062595
Status:
COMPLETED
Last Update Posted:
2016-05-17
First Post:
2003-06-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vitamin K and Bone Turnover in Postmenopausal Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010024', 'term': 'Osteoporosis'}], 'ancestors': [{'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010837', 'term': 'Vitamin K 1'}], 'ancestors': [{'id': 'D014812', 'term': 'Vitamin K'}, {'id': 'D009285', 'term': 'Naphthoquinones'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010836', 'term': 'Phytol'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D011809', 'term': 'Quinones'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 375}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-09'}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2004-10'}, 'lastUpdateSubmitDate': '2016-05-16', 'studyFirstSubmitDate': '2003-06-09', 'studyFirstSubmitQcDate': '2003-06-11', 'lastUpdatePostDateStruct': {'date': '2016-05-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-06-12', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['Menopause', 'Vitamin K', 'Bone turnover', 'Bone Density'], 'conditions': ['Osteoporosis']}, 'referencesModule': {'references': [{'pmid': '20881072', 'type': 'DERIVED', 'citation': 'Kumar R, Binkley N, Vella A. Effect of phylloquinone supplementation on glucose homeostasis in humans. Am J Clin Nutr. 2010 Dec;92(6):1528-32. doi: 10.3945/ajcn.2010.30108. Epub 2010 Sep 29.'}]}, 'descriptionModule': {'briefSummary': 'This one year study of the K vitamers phylloquinone (K1) and menatetranone (MK4) will study supplementation effects on bone turnover and bone density. Women at least 5 years postmenopause with normal bone density who do not use estrogen therapy or the following medications may be eligible:\n\nalendronate (Fosamax), risedronate (Actonel), pamidronate (Aredia), etidronate (Didronel), zoledronate (Zometa), teriparatide (Forteo), raloxifene (Evista), tamoxifene, warfarin (Coumadin), anti-seizure medications, prednisone, or oral steroids. Eligible subjects will take calcium and vitamin D (Citracal) twice a day for the first two months and through-out the study. After the first two months, subjects are randomized to the K1, MK4 or placebo groups. Return visits occur at 1, 3, 6 and 12 months. Fasting blood and urine is collected at each visit and bone density is performed at 3 study visits.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': '* Female, 5 years postmenopause.\n* Ambulatory.\n* Community dwelling.\n* Able to ingest calcium and vitamin D supplements.\n* Willing to restrict vitamin K intake.\n* Stable thyroid dose if appropriate.\n* No history of hyperthyroidism, hyperparathyroidism or other metabolic bone diseases.\n* Absence of hardware in hip and spine.\n* History of malignancy within the last five years.\n* Not currently using coumadin or warfarin.\n* Vitamin D supplements must be less than 800 IU daily.\n* Have not used estrogen or other bone-altering medications (see list in study description) within the last year.\n* No history of liver disease or malabsorption.\n* No known allergy to vitamin K.\n* Have not participated in an investigational drug trial within the last month.'}, 'identificationModule': {'nctId': 'NCT00062595', 'briefTitle': 'Vitamin K and Bone Turnover in Postmenopausal Women', 'organization': {'class': 'NIH', 'fullName': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)'}, 'officialTitle': 'Vitamin K and Bone Turnover in Postmenopausal Women', 'orgStudyIdInfo': {'id': 'DK58363 (completed 2005)'}}, 'armsInterventionsModule': {'interventions': [{'name': 'phylloquinone (K1)', 'type': 'DRUG'}, {'name': 'menatetranone (MK4)', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '53705', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of Wisconsin Osteoporosis Clinical Research Prog.', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}, 'collaborators': [{'name': 'Eisai Co., Ltd.', 'class': 'INDUSTRY'}]}}}