Ignite Creation Date:
2025-12-26 @ 10:56 AM
Ignite Modification Date:
2026-03-17 @ 4:01 AM
Study NCT ID:
NCT00591708
Status:
COMPLETED
Last Update Posted:
2018-05-09
First Post:
2007-12-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Calcium Metabolism in Asian Adolescents
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C083976', 'term': 'calcium citrate malate'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2005-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-03', 'studyFirstSubmitDate': '2007-12-26', 'studyFirstSubmitQcDate': '2008-01-10', 'lastUpdatePostDateStruct': {'date': '2018-05-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-01-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Calcium retention (mg/d)', 'timeFrame': 'Metabolic balance will be determined over a two week period on a controlled diet after equilibration for one week on the same diet.'}], 'secondaryOutcomes': [{'measure': 'Serial serum biochemistry profiles (PTH, 1,25 dihydroxy-vitamin D, calcium)', 'timeFrame': 'Six serial measurements in 10 hours after ingestion of a calcium load representing one third of the daily consumption'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['calcium', 'bone', 'bone density', 'adolescence'], 'conditions': ['Bone Mineralization', 'Adolescent Development']}, 'referencesModule': {'references': [{'pmid': '20205166', 'type': 'DERIVED', 'citation': 'Wu L, Martin BR, Braun MM, Wastney ME, McCabe GP, McCabe LD, DiMeglio LA, Peacock M, Weaver CM. Calcium requirements and metabolism in Chinese-American boys and girls. J Bone Miner Res. 2010 Aug;25(8):1842-9. doi: 10.1002/jbmr.76.'}]}, 'descriptionModule': {'briefSummary': 'Maximizing calcium retention by the skeleton within the genetic potential is a key strategy to prevent osteoporosis. It has been shown that calcium retention varies between blacks and whites and between gender within race. This study is designed to study the relationship between calcium intakes and calcium retention in Asian adolescent girls and boys. It is hypothesized that calcium intakes which maximize calcium retention will be lower in Asians than for whites studies under the same conditions. In addition it is thought that the differences between races in the physiological mechanisms involved in calcium metabolism will result in a lower calcium intake required to observe a plateau in calcium retention. This is turn could be translated into lower calcium requirements in Asians relative to Caucasians for achieving optimal peak bone mass.', 'detailedDescription': 'Adolescent Asian boys and girls will consume a controlled diet for two three-week periods. The basal diet will contain 600 mg/d calcium and will be supplemented with beverages fortified with calcium citrate malate to achieve a range of intakes from 600-2100 mg Ca/d. Each participant will be studied on one of four combinations of a lower and a higher calcium intake within that range in a cross-over design.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '11 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy teens of Asian descent\n\nExclusion Criteria:\n\n* malabsorptive disorders\n* anemia\n* smoking, illegal drugs\n* oral contraceptives\n* pregnancy\n* drugs that influence calcium metabolism\n* body weight for height greater than 85 percentile'}, 'identificationModule': {'nctId': 'NCT00591708', 'briefTitle': 'Calcium Metabolism in Asian Adolescents', 'organization': {'class': 'OTHER', 'fullName': 'Purdue University'}, 'officialTitle': 'Calcium Metabolism in Asian Adolescents', 'orgStudyIdInfo': {'id': 'AR40553'}, 'secondaryIdInfos': [{'id': 'R01AR040553', 'link': 'https://reporter.nih.gov/quickSearch/R01AR040553', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'B', 'description': 'Supplementation of a higher level of calcium (500-1300 mg/d) via calcium fortified beverages (calcium citrate malate) to a basal diet of 600 mg/d for 21 consecutive days. All excreta will be collected.', 'interventionNames': ['Dietary Supplement: Beverage fortified with calcium citrate malate']}, {'type': 'EXPERIMENTAL', 'label': 'A', 'description': 'Supplementation of a lower level of calcium (0-400 mg/d) via calcium fortified beverages (calcium citrate malate) to a basal diet of 600 mg/d for 21 consecutive days. All excreta will be collected.', 'interventionNames': ['Dietary Supplement: Beverage containing calcium citrate malate']}], 'interventions': [{'name': 'Beverage containing calcium citrate malate', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Beverages containing a lower amount of calcium (0-400 mg/d) will be supplemented to a basal diet containing 600 mg/d Ca. The controlled diet will be consumed for 21 consecutive days.', 'armGroupLabels': ['A']}, {'name': 'Beverage fortified with calcium citrate malate', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Beverages containing a higher amount of calcium (500-1300 mg/d) will be supplemented to a basal diet containing 600 mg/d Ca. The controlled diet will be consumed for 21 consecutive days.', 'armGroupLabels': ['B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '47907-2059', 'city': 'West Lafayette', 'state': 'Indiana', 'country': 'United States', 'facility': 'Department of Foods and Nutrition, Purdue University', 'geoPoint': {'lat': 40.42587, 'lon': -86.90807}}], 'overallOfficials': [{'name': 'Connie Weaver, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Foods and Nutrition, Purdue University'}, {'name': 'Berdine R Martin, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Foods and Nutrition, Purdue University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Purdue University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Scientist, Nutrition Science', 'investigatorFullName': 'Berdine Martin', 'investigatorAffiliation': 'Purdue University'}}}}