Ignite Creation Date:
2025-12-24 @ 7:14 PM
Ignite Modification Date:
2026-04-22 @ 1:42 AM
Study NCT ID:
NCT02525003
Status:
COMPLETED
Last Update Posted:
2015-08-17
First Post:
2015-08-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The BreaD Study - Bio-availability of D2 Vitamin Present in Bread
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004872', 'term': 'Ergocalciferols'}, {'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': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 41}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-13', 'studyFirstSubmitDate': '2015-08-10', 'studyFirstSubmitQcDate': '2015-08-13', 'lastUpdatePostDateStruct': {'date': '2015-08-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-08-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum total 25-hydroxyvitamin D (25(OH)D)', 'timeFrame': 'Change from baseline in total 25(OH)D concentration at 4 and 8 weeks', 'description': 'The effect of vitamin D (as form of D3, D2 or D2-fortified bread )supplementation on the serum 25(OH)D concentration'}], 'secondaryOutcomes': [{'measure': 'Serum parathyroid hormone (PTH) concentration', 'timeFrame': 'Change from baseline in serum PTH concentration at 4 and 8 weeks', 'description': 'The effect of vitamin D (as form of D3, D2 or D2-fortified bread )supplementation on the serum PTH concentration'}, {'measure': 'Serum calcium concentration', 'timeFrame': 'Change from baseline in serum calcium concentration at 4 and 8 weeks', 'description': 'The effect of vitamin D (as form of D3, D2 or D2-fortified bread )supplementation on the serum calcium concentration'}, {'measure': 'Serum 25-hydroxyvitamin D2 (25(OH)D2)', 'timeFrame': 'Change from baseline in 25(OH)D2 concentration at 4 and 8 weeks', 'description': 'The effect of vitamin D (as form of D3, D2 or D2-fortified bread )supplementation on the serum 25(OH)D2 concentration'}, {'measure': 'Serum 25-hydroxyvitamin D3 (25(OH)D3)', 'timeFrame': 'Change from baseline in 25(OH)D3 concentration at 4 and 8 weeks', 'description': 'The effect of vitamin D (as form of D3, D2 or D2-fortified bread )supplementation on the serum 25(OH)D3 concentration'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['vitamin D', 'Serum 25-hydroxyvitamin D', 'vitamin D2', 'UV-irradiated yeast', 'serum 25-hydroxyvitamin D3', 'serum 25-hydroxyvitamin D2', 'randomized controlled trial', 'vitamin D3', 'bioavailability'], 'conditions': ['Serum 25-hydroxyvitamin D Concentrations (25OHD)']}, 'descriptionModule': {'briefSummary': 'Vitamin D3 is synthesized in skin exposed to ultraviolet-B-irradiation of sunlight. However, in Northern Europe, including Finland, exposure to sunlight is limited or non-existent in winter. Between November and March, dietary or supplementary vitamin D intake is essential to maintain adequate serum 25-hydroxyvitamin D (S-25(OH)D) concentrations. There are only a few natural dietary sources of vitamin D. Fish and egg yolks contain significant amounts of vitamin D3 (cholecalciferol), and some wild mushrooms are a source of vitamin D2 (ergocalciferol). Thus, vitamin D fortification of certain foods has been accepted as one strategy to improve vitamin D status of these populations. Vitamin D3 is currently mostly used in fortified products in Europe, although the production of plant-derived vitamin D2 would be more cost-effective. Data on the impact of food-derived vitamin D2 on S-25(OH)D3 are limited. An important consideration is whether food-based sources of vitamin D2 are effective in raising S-25(OH)D or whether they have a negative impact on S-25(OH)D3. The investigators investigated the bioavailability of vitamin D2 from UVB-radiated baking yeast in bread in terms of efficacy of raising total S-25(OH)D) as well its possible effects on S-25(OH)D2, S-25(OH)D3, serum parathyroid hormone (S-PTH) and serum calcium concentrations compared with D2 and D3 supplementation in a randomized placebo-controlled trial in young healthy females during winter in Finland.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* good general health (no continuous medication),\n* Caucasian origin,\n* body mass index (BMI) \\<30 kg/m2\n* age 20-40 years\n\nExclusion Criteria:\n\n* diagnosed celiac disease or cereal allergy\n* a vacation in a sunny place during the study or within the preceding 2 months\n* regular use of vitamin D supplements \\>15 µg/d\n* pregnancy or breastfeeding during the study'}, 'identificationModule': {'nctId': 'NCT02525003', 'acronym': 'BreaD_ODIN', 'briefTitle': 'The BreaD Study - Bio-availability of D2 Vitamin Present in Bread', 'organization': {'class': 'OTHER', 'fullName': 'University of Helsinki'}, 'officialTitle': 'Work Package 5: The Potential Advantages and Limitations of Use of Novel Food-based Solutions for Prevention of Vitamin D Deficiency. Food-based Solutions for Optimal Vitamin D Nutrition and Health Through the Life Cycle (ODIN)', 'orgStudyIdInfo': {'id': 'HelsinkiUni'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Group 1: placebo', 'description': 'Group 1: daily dose of regular bread (87 g/d) and placebo pill (0 µg of vitamin D/d) for 8 weeks'}, {'type': 'EXPERIMENTAL', 'label': 'Group 2: Vitamin D2 supplement', 'description': 'Group 2: daily dose of regular bread (87 g/d) and D2 supplement (25 µg of vitamin D2/d.) for 8 weeks', 'interventionNames': ['Dietary Supplement: Vitamin D2']}, {'type': 'EXPERIMENTAL', 'label': 'Group 3: Vitamin D3 supplement', 'description': 'Group 3: daily dose of regular bread (87 g/d) and D3 supplement (25 µg of vitamin D3/d.) for 8 weeks', 'interventionNames': ['Dietary Supplement: Vitamin D3']}, {'type': 'EXPERIMENTAL', 'label': 'Group 4: Vitamin D2-fortified bread', 'description': 'Group 4: D2 fortified bread containing 25 µg of vitamin D2/d (bread dose 87g/d) and placebo pill for 8 weeks', 'interventionNames': ['Other: Vitamin D2 fortified bread']}], 'interventions': [{'name': 'Vitamin D2', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Experimental group 2: daily vitamin D2 supplement 25ug/d for 8 weeks', 'armGroupLabels': ['Group 2: Vitamin D2 supplement']}, {'name': 'Vitamin D3', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Experimental group 3: daily vitamin D3 supplement 25ug/d for 8 weeks', 'armGroupLabels': ['Group 3: Vitamin D3 supplement']}, {'name': 'Vitamin D2 fortified bread', 'type': 'OTHER', 'description': 'Experimental group 4: vitamin D2 fortified bread containing 25 µg of vitamin D2/d (bread dose 87g/d) and placebo pill for 8 weeks', 'armGroupLabels': ['Group 4: Vitamin D2-fortified bread']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Helsinki', 'country': 'Finland', 'facility': 'Department of Food and Environmental Sciences, University of Helsinki', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}], 'overallOfficials': [{'name': 'Christel Lamberg-Allardt', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Helsinki'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Helsinki', 'class': 'OTHER'}, 'collaborators': [{'name': 'University College Cork', 'class': 'OTHER'}, {'name': 'Technical University of Denmark', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Christel Lamberg-Allardt', 'investigatorAffiliation': 'University of Helsinki'}}}}