Ignite Creation Date:
2025-12-24 @ 3:30 PM
Ignite Modification Date:
2026-01-01 @ 11:58 PM
Study NCT ID:
NCT01631292
Status:
COMPLETED
Last Update Posted:
2023-11-22
First Post:
2011-06-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vitamin D Supplementation in Obesity and Weight Loss (3DD Study)
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': 'D002762', 'term': 'Cholecalciferol'}], 'ancestors': [{'id': 'D002782', 'term': 'Cholestenes'}, {'id': 'D002776', 'term': 'Cholestanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013261', 'term': 'Sterols'}, {'id': 'D014807', 'term': 'Vitamin D'}, {'id': 'D012632', 'term': 'Secosteroids'}, {'id': 'D008563', 'term': 'Membrane Lipids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 81}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2019-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-20', 'studyFirstSubmitDate': '2011-06-30', 'studyFirstSubmitQcDate': '2012-06-27', 'lastUpdatePostDateStruct': {'date': '2023-11-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-06-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bone mineral density (BMD)', 'timeFrame': '1 year', 'description': 'BMD'}, {'measure': 'Bone quality', 'timeFrame': '1 year', 'description': 'thickness (mm)'}], 'secondaryOutcomes': [{'measure': 'Bone turnover markers', 'timeFrame': 'Baseline, 6 months, 12 months', 'description': 'osteocalcin (others include PINP and CTX)'}, {'measure': 'Glycemic indices', 'timeFrame': 'Baseline, 6 months and 12 months', 'description': 'glucose and insulin'}, {'measure': 'Cognition and biochemical markers', 'timeFrame': 'One year', 'description': 'Cognitive measures and serum biochemical markers'}, {'measure': 'cholesterol absorption', 'timeFrame': 'baseline and one year', 'description': 'Serum levels'}, {'measure': 'serum vitamin D', 'timeFrame': 'Baseline, 6 months and 12 months', 'description': '25(OH)D'}, {'measure': 'Bone regulating hormones', 'timeFrame': 'Baseline, 6 months and 12 months', 'description': 'PTH'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Osteoporosis']}, 'referencesModule': {'references': [{'pmid': '30951148', 'type': 'BACKGROUND', 'citation': 'Castle M, Fiedler N, Pop LC, Schneider SJ, Schlussel Y, Sukumar D, Hao L, Shapses SA. Three Doses of Vitamin D and Cognitive Outcomes in Older Women: A Double-Blind Randomized Controlled Trial. J Gerontol A Biol Sci Med Sci. 2020 Apr 17;75(5):835-842. doi: 10.1093/gerona/glz041.'}, {'pmid': '27535752', 'type': 'BACKGROUND', 'citation': 'Pop LC, Sukumar D, Schneider SH, Schlussel Y, Stahl T, Gordon C, Wang X, Papathomas TV, Shapses SA. Three doses of vitamin D, bone mineral density, and geometry in older women during modest weight control in a 1-year randomized controlled trial. Osteoporos Int. 2017 Jan;28(1):377-388. doi: 10.1007/s00198-016-3735-z. Epub 2016 Aug 17.'}, {'pmid': '35538903', 'type': 'DERIVED', 'citation': 'Ogilvie AR, Schlussel Y, Sukumar D, Meng L, Shapses SA. Higher protein intake during caloric restriction improves diet quality and attenuates loss of lean body mass. Obesity (Silver Spring). 2022 Jul;30(7):1411-1419. doi: 10.1002/oby.23428. Epub 2022 May 11.'}]}, 'descriptionModule': {'briefSummary': 'In this study, we will provide supplemental vitamin D in postmenopausal overweight/obese women, and hypothesize that it will not affect areal BMD, but will alter bone compartments (trabecular and cortical bone). In addition, higher vitamin D intake will increase serum 25OHD and suppress serum PTH and bone turnover during weight reduction. Secondary outcomes include the influence of vitamin D and weight loss on markers of insulin resistance and on cognitive tests of attention, learning, and memory.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '72 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body mass index of 25-40 kg/m2\n* Postmenopausal\n* Age 50-72 years\n\nExclusion Criteria:\n\n* Women who are taking any medication known to influence Calcium or bone metabolism,\n* Evidence of diseases known to influence Calcium metabolism (i.e. metabolic bone disease)\n* hyperparathyroidism\n* untreated thyroid disease\n* significant immune disease\n* hepatic disease\n* renal disease or a kidney stone in the last 5 years\n* significant cardiac disease\n* active malignancy or cancer therapy within the past year'}, 'identificationModule': {'nctId': 'NCT01631292', 'briefTitle': 'Vitamin D Supplementation in Obesity and Weight Loss (3DD Study)', 'organization': {'class': 'OTHER', 'fullName': 'Rutgers, The State University of New Jersey'}, 'officialTitle': 'A Pilot Dose Response Study to Vitamin D in Obesity and Weight Loss: Effect on Bone', 'orgStudyIdInfo': {'id': 'BBGP201095157'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': '600 IU D3', 'interventionNames': ['Dietary Supplement: 600 IU Vitamin D3']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2000 IU D3', 'interventionNames': ['Dietary Supplement: 2000 IU Vitamin D3']}, {'type': 'ACTIVE_COMPARATOR', 'label': '4000 IU D3', 'interventionNames': ['Dietary Supplement: 4000 IU Vitamin D3']}], 'interventions': [{'name': '600 IU Vitamin D3', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Once daily', 'armGroupLabels': ['600 IU D3']}, {'name': '2000 IU Vitamin D3', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Once daily', 'armGroupLabels': ['2000 IU D3']}, {'name': '4000 IU Vitamin D3', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Once daily', 'armGroupLabels': ['4000 IU D3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08901', 'city': 'New Brunswick', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Rutgers University- Thompson Hall', 'geoPoint': {'lat': 40.48622, 'lon': -74.45182}}], 'overallOfficials': [{'name': 'Sue Shapses, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rutgers University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rutgers University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Sue A. Shapses, Ph.D., RD', 'investigatorAffiliation': 'Rutgers University'}}}}