Clinical trial NCT02525003: The BreaD Study - Bio-availability of D2 Vitamin Present in Bread
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Serum 25-hydroxyvitamin D Concentrations (25OHD)
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
Lead sponsor: University of Helsinki
Sponsor class: OTHER
Collaborators: name: University College Cork
name: Technical University of Denmark
First posted: 2015-08-17
Enrollment: 41
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: Inclusion Criteria:

* good general health (no continuous medication),
* Caucasian origin,
* body mass index (BMI) \<30 kg/m2
* age 20-40 years

Exclusion Criteria:

* diagnosed celiac disease or cereal allergy
* a vacation in a sunny place during the study or within the preceding 2 months
* regular use of vitamin D supplements \>15 µg/d
* pregnancy or breastfeeding during the study

Primary outcomes:
measure: Serum total 25-hydroxyvitamin D (25(OH)D)
timeFrame: Change from baseline in total 25(OH)D concentration at 4 and 8 weeks
Secondary outcomes:
measure: Serum parathyroid hormone (PTH) concentration
timeFrame: Change from baseline in serum PTH concentration at 4 and 8 weeks
measure: Serum calcium concentration
timeFrame: Change from baseline in serum calcium concentration at 4 and 8 weeks
measure: Serum 25-hydroxyvitamin D2 (25(OH)D2)
timeFrame: Change from baseline in 25(OH)D2 concentration at 4 and 8 weeks
measure: Serum 25-hydroxyvitamin D3 (25(OH)D3)
timeFrame: Change from baseline in 25(OH)D3 concentration at 4 and 8 weeks
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Department of Food and Environmental Sciences, University of Helsinki
Study officials:
affiliation: University of Helsinki
name: Christel Lamberg-Allardt
role: STUDY_DIRECTOR
References: