Ignite Creation Date:
2025-12-24 @ 2:08 PM
Ignite Modification Date:
2026-02-25 @ 8:28 PM
Study NCT ID:
NCT02145195
Status:
COMPLETED
Last Update Posted:
2015-03-25
First Post:
2014-05-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Vitamin D Supplements on Vitamin D Status, Cardiometabolic Health and Immune Defense in Danish Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2018-12-20', 'releaseDate': '2018-06-12'}], 'estimatedResultsFirstSubmitDate': '2018-06-12'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D014808', 'term': 'Vitamin D Deficiency'}], 'ancestors': [{'id': 'D001361', 'term': 'Avitaminosis'}, {'id': 'D003677', 'term': 'Deficiency Diseases'}, {'id': 'D044342', 'term': 'Malnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'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': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 130}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-24', 'studyFirstSubmitDate': '2014-05-20', 'studyFirstSubmitQcDate': '2014-05-20', 'lastUpdatePostDateStruct': {'date': '2015-03-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-05-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in cardio-metabolic markers', 'timeFrame': 'Baseline and 20 weeks', 'description': 'Blood pressure, insulin, cholesterols etc.'}, {'measure': 'Change in markers of immune defense', 'timeFrame': 'Baseline and 20 weeks', 'description': 'Production of cytokines in whole blood cultures. Expression of immune markers and antiviral and antimicrobial peptides.'}, {'measure': 'Change in muscle strength', 'timeFrame': 'Baseline and 20 weeks', 'description': 'Maximum hand grip strength.'}, {'measure': 'Dietary intake of vitamin D and calcium', 'timeFrame': 'Baseline and 20 weeks', 'description': 'Assessed by questionnaire'}], 'primaryOutcomes': [{'measure': 'Change in vitamin D status', 'timeFrame': 'Baseline and 20 weeks', 'description': 'Serum concentrations of total 25-hydroxyvitamin D \\[25(OH)D\\]'}], 'secondaryOutcomes': [{'measure': 'Change in anthropometric measurements', 'timeFrame': 'Baseline and 20 weeks', 'description': 'Waist circumference, body weight, height, body mass index (BMI) and BMI z-scores.'}, {'measure': 'Change in body composition', 'timeFrame': 'Baseline and 20 weeks', 'description': 'Fat mass, fat mass index (kg/m2), fat free mass and fat free mass index (kg/m2).'}, {'measure': 'Serum calcium', 'timeFrame': 'Baseline and 20 weeks', 'description': 'Serum calcium (adjusted for albumin) evaluated after the first visit has been completed for all children, and after the second visit.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Vitamin D', 'Children', 'Supplements', 'Cardiometabolic markers', 'Immune defense', 'Bone turnover', 'Muscle strength'], 'conditions': ['Vitamin D Deficiency']}, 'referencesModule': {'references': [{'pmid': '30189911', 'type': 'DERIVED', 'citation': 'Mortensen C, Molgaard C, Hauger H, Kristensen M, Damsgaard CT. Sun behaviour and physical activity associated with autumn vitamin D status in 4-8-year-old Danish children. Public Health Nutr. 2018 Dec;21(17):3158-3167. doi: 10.1017/S1368980018002094. Epub 2018 Sep 7.'}, {'pmid': '29917069', 'type': 'DERIVED', 'citation': 'Hauger H, Molgaard C, Mortensen C, Ritz C, Frokiaer H, Smith TJ, Hart K, Lanham-New SA, Damsgaard CT. Winter Cholecalciferol Supplementation at 55 degrees N Has No Effect on Markers of Cardiometabolic Risk in Healthy Children Aged 4-8 Years. J Nutr. 2018 Aug 1;148(8):1261-1268. doi: 10.1093/jn/nxy080.'}, {'pmid': '29450728', 'type': 'DERIVED', 'citation': 'Mortensen C, Molgaard C, Hauger H, Kristensen M, Damsgaard CT. Winter vitamin D3 supplementation does not increase muscle strength, but modulates the IGF-axis in young children. Eur J Nutr. 2019 Apr;58(3):1183-1192. doi: 10.1007/s00394-018-1637-x. Epub 2018 Feb 15.'}, {'pmid': '27733403', 'type': 'DERIVED', 'citation': 'Mortensen C, Damsgaard CT, Hauger H, Ritz C, Lanham-New SA, Smith TJ, Hennessy A, Dowling K, Cashman KD, Kiely M, Molgaard C. Estimation of the dietary requirement for vitamin D in white children aged 4-8 y: a randomized, controlled, dose-response trial. Am J Clin Nutr. 2016 Nov;104(5):1310-1317. doi: 10.3945/ajcn.116.136697. Epub 2016 Oct 12.'}]}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to investigate whether and in which doses vitamin D intake is needed in order to maintain an adequate vitamin D status in 4-8 year-old Danish children during wintertime.', 'detailedDescription': 'The main objective of ODIN Junior is to investigate whether and in which doses vitamin D intake is needed in order to maintain serum 25(OH)D concentrations above deficiency and insufficiency cut-offs (30 nmol/L and 50 nmol/L, respectively) in 4-8 year-old Danish children during the winter time. The children will be randomized to receive tablets with either 10 micrograms/day or 20 microgram/day of vitamin D3 (cholecalciferol), corresponding to one and two times the recommended daily intake in children, or placebo for 20 weeks. Measurements and blood sampling will be performed before the beginning and by the end of the intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '8 Years', 'minimumAge': '4 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 4-8 years at the start of the intervention\n* healthy\n* of white, Danish/European origin\n* children must be Danish-speaking\n* parents must read and speak Danish\n* not planning a winter vacation south of a latitude of 51°North (corresponding to Surrey, England)\n\nExclusion Criteria:\n\n* diseases that may interfere with vitamin D or calcium metabolism\n* intake of medication known to affect vitamin D or calcium metabolism\n* use of vitamin D containing supplements ≥ 4 days/week the last 8 weeks before intervention start and use of any vitamin D containing supplements the last 4 weeks before intervention start\n* concomitant participation in other studies involving dietary supplements or blood sampling\n* serum calcium \\> 2.7 mmol/L at baseline'}, 'identificationModule': {'nctId': 'NCT02145195', 'acronym': 'ODIN Junior', 'briefTitle': 'The Effect of Vitamin D Supplements on Vitamin D Status, Cardiometabolic Health and Immune Defense in Danish Children', 'organization': {'class': 'OTHER', 'fullName': 'University of Copenhagen'}, 'officialTitle': 'Food-based Solutions for Optimal Vitamin D Nutrition and Health Through the Life Cycle (ODIN) Junior', 'orgStudyIdInfo': {'id': 'D214'}, 'secondaryIdInfos': [{'id': 'European Commission', 'type': 'OTHER_GRANT', 'domain': 'Contract no. 613977'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vitamin D (10 microgram/day)', 'description': 'Tablets with 10 microgram vitamin D3 (cholecalciferol) daily for 20 weeks.', 'interventionNames': ['Dietary Supplement: Vitamin D3 (cholecalciferol)']}, {'type': 'EXPERIMENTAL', 'label': 'Vitamin D (20 microgram/day)', 'description': 'Tablets with 20 microgram vitamin D3 (cholecalciferol) daily for 20 weeks.', 'interventionNames': ['Dietary Supplement: Vitamin D3 (cholecalciferol)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo control', 'description': 'Tablets with 0 microgram vitamin D daily for 20 weeks.'}], 'interventions': [{'name': 'Vitamin D3 (cholecalciferol)', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Vitamin D (10 microgram/day)', 'Vitamin D (20 microgram/day)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1958', 'city': 'Copenhagen', 'state': 'Frederiksberg', 'country': 'Denmark', 'facility': 'Department of Nutrition, Exercise and Sports', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Christian Mølgaard, PhD, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Section of Peadiatric and International Nutrition, Department of Nutrition, Exercise and Sports, University of Copenhagen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Copenhagen', 'class': 'OTHER'}, 'collaborators': [{'name': 'University College Cork', 'class': 'OTHER'}, {'name': 'University of Surrey', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, Associate Professor', 'investigatorFullName': 'Christian Mølgaard', 'investigatorAffiliation': 'University of Copenhagen'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2018-06-12', 'type': 'RELEASE'}, {'date': '2018-12-20', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Christian Mølgaard, MD, Associate Professor, University of Copenhagen'}}}}