The BreaD Study - Bio-availability of D2 Vitamin Present in Bread
NCT02525003 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 41
Last updated 2015-08-17
Summary
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.
Conditions
- Serum 25-hydroxyvitamin D Concentrations (25OHD)
Interventions
- DIETARY_SUPPLEMENT
-
Vitamin D2
Experimental group 2: daily vitamin D2 supplement 25ug/d for 8 weeks
- DIETARY_SUPPLEMENT
-
Vitamin D3
Experimental group 3: daily vitamin D3 supplement 25ug/d for 8 weeks
- OTHER
-
Vitamin D2 fortified bread
Experimental group 4: vitamin D2 fortified bread containing 25 µg of vitamin D2/d (bread dose 87g/d) and placebo pill for 8 weeks
Sponsors & Collaborators
-
University College Cork
collaborator OTHER -
Technical University of Denmark
collaborator OTHER -
University of Helsinki
lead OTHER
Principal Investigators
-
Christel Lamberg-Allardt · University of Helsinki
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 20 Years
- Max Age
- 40 Years
- Sex
- FEMALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2014-01-31
- Primary Completion
- 2014-04-30
- Completion
- 2014-04-30
Countries
- Finland
Study Locations
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