Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2026-03-08 @ 3:31 AM
Study NCT ID:
NCT01711905
Status:
COMPLETED
Last Update Posted:
2013-04-22
First Post:
2012-10-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study on the Effects of a Recommendation Based Supply of Vitamin D3 in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 107}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04', 'completionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-04-19', 'studyFirstSubmitDate': '2012-10-15', 'studyFirstSubmitQcDate': '2012-10-18', 'lastUpdatePostDateStruct': {'date': '2013-04-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-10-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '25-hydroxyvitamin D3', 'timeFrame': 'after 12 weeks of supplementation', 'description': 'major outcome variable is the increase of 25-hydroxyvitamin D3 in the treatment group in comparison with the placebo group'}], 'secondaryOutcomes': [{'measure': 'atherosclerotic risk factors', 'timeFrame': 'after 12 weeks of supplementation', 'description': 'It is the objective of this study to investigate whether a supplementation with Vitamin D3 can be used to reduce atherosclerotic risk factors such as hypertension, inflammation and hyperlipidemia. The research question is whether Vitamin D3 can reduces the level of systemic inflammation and whether Vitamin D3 has an effect on blood lipids.'}, {'measure': 'inflammation', 'timeFrame': 'after 12 weeks of supplementation', 'description': 'It is the objective of this study to investigate whether a supplementation with Vitamin D3 can be used to reduce inflammation as an atherosclerotic risk factor'}, {'measure': 'hyperlipidemia', 'timeFrame': 'after 12 weeks of supplementation', 'description': 'It is the objective of this study to investigate whether a supplementation with Vitamin D3 can be used to reduce hyperlipidemia as an atherosclerotic risk factor'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Deficiency of Vitamin D3']}, 'referencesModule': {'references': [{'pmid': '26037521', 'type': 'DERIVED', 'citation': 'Lehmann U, Riedel A, Hirche F, Brandsch C, Girndt M, Ulrich C, Seibert E, Henning C, Glomb MA, Dierkes J, Stangl GI. Vitamin D3 supplementation: Response and predictors of vitamin D3 metabolites - A randomized controlled trial. Clin Nutr. 2016 Apr;35(2):351-358. doi: 10.1016/j.clnu.2015.04.021. Epub 2015 May 19.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to investigate whether a supplementation of 20 µg Vitamin D3 per day for 12 weeks can be used to normalize vitamin d-Status', 'detailedDescription': 'It is the objective of this study to investigate whether a supplementation with Vitamin D3 can be used to normalize insufficient vitamin d status and reduce atherosclerotic risk factors such as hypertension, inflammation and hyperlipidemia. The research question is whether Vitamin D3 reduces the level of systemic inflammation and whether Vitamin D3 has an effect on blood lipids.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy volunteers\n* age between 18 and 70 years\n* informed consent\n\nExclusion Criteria:\n\n* use of antihypertensive medication\n* use of vitamin d or calcium supplements\n* known renal, inflammatory or malignant diseases\n* hypercalcemia or hypercalciuria\n* participation in other clinical studies\n* use of tanning booths during the study\n* pregnancy or lactating period'}, 'identificationModule': {'nctId': 'NCT01711905', 'briefTitle': 'Study on the Effects of a Recommendation Based Supply of Vitamin D3 in Healthy Volunteers', 'organization': {'class': 'OTHER', 'fullName': 'Martin-Luther-Universität Halle-Wittenberg'}, 'officialTitle': 'Study on the Effects of a Recommendation Based Supply of Vitamin D3 in Healthy Volunteers - a Randomized Trail', 'orgStudyIdInfo': {'id': '0315668'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vitamin D3', 'description': 'cholecalciferol 20 µg per day for 12 weeks', 'interventionNames': ['Dietary Supplement: Vitamin D3']}, {'type': 'NO_INTERVENTION', 'label': 'Placebo', 'description': 'Placebo for 12 weeks'}], 'interventions': [{'name': 'Vitamin D3', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['cholecalciferol'], 'description': 'daily dosage of 20 µg Vitamin D3 for 12 weeks', 'armGroupLabels': ['Vitamin D3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06120', 'city': 'Halle', 'state': 'Saxony-Anhalt', 'country': 'Germany', 'facility': 'Naturwissenschaftliche Fakultät III', 'geoPoint': {'lat': 51.48158, 'lon': 11.97947}}], 'overallOfficials': [{'name': 'Gabriele I Stangl, Prof. Dr.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Institut für Agrar- und Ernährungswissenschaften'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Martin-Luther-Universität Halle-Wittenberg', 'class': 'OTHER'}, 'collaborators': [{'name': 'German Federal Ministry of Education and Research', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ulrike Lehmann', 'investigatorAffiliation': 'Martin-Luther-Universität Halle-Wittenberg'}}}}