Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2026-03-03 @ 12:03 AM
Study NCT ID:
NCT01398202
Status:
COMPLETED
Last Update Posted:
2015-12-02
First Post:
2011-07-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dietary Supplementation With 25-hydroxyvitamin D3 in Older Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D002762', 'term': 'Cholecalciferol'}, {'id': 'D002112', 'term': 'Calcifediol'}, {'id': 'C104450', 'term': '25-hydroxyvitamin D'}], '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'}, {'id': 'D006887', 'term': 'Hydroxycholecalciferols'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-11-30', 'studyFirstSubmitDate': '2011-07-18', 'studyFirstSubmitQcDate': '2011-07-19', 'lastUpdatePostDateStruct': {'date': '2015-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-07-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'serum 25-hydroxyvitamin D concentration', 'timeFrame': '10 weeks'}], 'secondaryOutcomes': [{'measure': 'serum parathyroid hormone', 'timeFrame': '10 weeks'}, {'measure': 'blood pressure', 'timeFrame': '10 weeks'}, {'measure': 'biochemical markers of bone turnover', 'timeFrame': '10 weeks'}, {'measure': 'serum calcium adjusted for albumin', 'timeFrame': '10 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Vitamin D status', '25-hydroxyvitamin D', 'Vitamin D3', 'RCT', 'Bio-efficacy'], 'conditions': ['Vitamin D Status as Reflected by Serum 25-hydroxyvitamin D']}, 'referencesModule': {'references': [{'pmid': '22552038', 'type': 'DERIVED', 'citation': 'Cashman KD, Seamans KM, Lucey AJ, Stocklin E, Weber P, Kiely M, Hill TR. Relative effectiveness of oral 25-hydroxyvitamin D3 and vitamin D3 in raising wintertime serum 25-hydroxyvitamin D in older adults. Am J Clin Nutr. 2012 Jun;95(6):1350-6. doi: 10.3945/ajcn.111.031427. Epub 2012 May 2.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate whether a supplement of 25-hydroxyvitamin D is five-times more potent in raising vitamin D status (as reflected by serum 25(OH)D) compared to an equivalent amount of vitamin D3 in older adults. It will entail a 10 week supplementation study during winter months.', 'detailedDescription': 'The UK (McCance \\& Widdowson) food composition tables suggests that 25-hydroxyvitamin D (which is present in some foods, albeit at very low concentrations, but which is also commercially available) may possess up to 5-times the activity of native vitamin D3 in food. Thus, in theory, each micogram of 25-hydroxyvitamin D consumed in the diet could boost vitamin D status up to five times most effectively compared to each microgram of native vitamin D in food. It is worth noting, however, that estimates of potency range from 2 to 5, depending on approach used, and that the real potency needs to be confirmed in a human study. This study aims to examine the biological activity of 25-hydroxyvitamin D (i.e., its potency relative to vitamin D3) as well as its effect on selected functional markers in a randomised, double-blind, human intervention trial in older adults.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '45 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects will be eligible if they are 45+ years of age\n* Body Mass Index (BMI) 19-30\n\nExclusion Criteria:\n\n* have hypercalcaemia\n* chronic illness\n* renal or liver disorders\n* taking medications that might interact with vitamin D or metabolite\n* drank more than \\> 21 standards (male)/ 14 standards (female) of alcohol per week\n* planning to change smoking habits'}, 'identificationModule': {'nctId': 'NCT01398202', 'briefTitle': 'Dietary Supplementation With 25-hydroxyvitamin D3 in Older Adults', 'organization': {'class': 'OTHER', 'fullName': 'University College Cork'}, 'officialTitle': 'Comparison of the Bioefficacy of Oral 25-hydroxyvitamin D3 and Vitamin D3 Supplements on Vitamin D Status in Older Adults', 'orgStudyIdInfo': {'id': '111'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Vitamin D3 (20 microgram/day)', 'interventionNames': ['Dietary Supplement: vitamin D3']}, {'type': 'ACTIVE_COMPARATOR', 'label': '25-hydroxyvitamin D (7 microgram/day)', 'interventionNames': ['Dietary Supplement: 25-hydroxyvitamin D3']}, {'type': 'ACTIVE_COMPARATOR', 'label': '25-hydroxyvitamin D3 (20 micogram/day)', 'interventionNames': ['Dietary Supplement: 25-hydroxyvitamin D (20 microgram/day)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'vitamin D3', 'type': 'DIETARY_SUPPLEMENT', 'description': '20 micrograms per day for 10 weeks', 'armGroupLabels': ['Vitamin D3 (20 microgram/day)']}, {'name': '25-hydroxyvitamin D3', 'type': 'DIETARY_SUPPLEMENT', 'description': '7 microgram/day for 10 weeks', 'armGroupLabels': ['25-hydroxyvitamin D (7 microgram/day)']}, {'name': '25-hydroxyvitamin D (20 microgram/day)', 'type': 'DIETARY_SUPPLEMENT', 'description': '20 microgramday for 10 weeks', 'armGroupLabels': ['25-hydroxyvitamin D3 (20 micogram/day)']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': '0 ug vitamin D3/25-hydroxyvitamin D3/day for 10 weeks', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cork', 'country': 'Ireland', 'facility': 'University College Cork', 'geoPoint': {'lat': 51.89797, 'lon': -8.47061}}], 'overallOfficials': [{'name': 'Kevin D Cashman, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University College Cork'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University College Cork', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Food and Health', 'investigatorFullName': 'Kevin D. Cashman', 'investigatorAffiliation': 'University College Cork'}}}}