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The BreaD Study - Bio-availability of D2 Vitamin Present in Bread

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)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02525003
Acronym
BreaD_ODIN
Enrollment
41
Registered
2015-08-17
Start date
2014-01-31
Completion date
2014-04-30
Last updated
2015-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

DIETARY_SUPPLEMENTVitamin D2

Experimental group 2: daily vitamin D2 supplement 25ug/d for 8 weeks

DIETARY_SUPPLEMENTVitamin D3

Experimental group 3: daily vitamin D3 supplement 25ug/d for 8 weeks

OTHERVitamin 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

University College Cork
CollaboratorOTHER
Technical University of Denmark
CollaboratorOTHER
University of Helsinki
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Serum total 25-hydroxyvitamin D (25(OH)D)Change from baseline in total 25(OH)D concentration at 4 and 8 weeksThe effect of vitamin D (as form of D3, D2 or D2-fortified bread )supplementation on the serum 25(OH)D concentration

Secondary

MeasureTime frameDescription
Serum parathyroid hormone (PTH) concentrationChange from baseline in serum PTH concentration at 4 and 8 weeksThe effect of vitamin D (as form of D3, D2 or D2-fortified bread )supplementation on the serum PTH concentration
Serum calcium concentrationChange from baseline in serum calcium concentration at 4 and 8 weeksThe effect of vitamin D (as form of D3, D2 or D2-fortified bread )supplementation on the serum calcium concentration
Serum 25-hydroxyvitamin D2 (25(OH)D2)Change from baseline in 25(OH)D2 concentration at 4 and 8 weeksThe effect of vitamin D (as form of D3, D2 or D2-fortified bread )supplementation on the serum 25(OH)D2 concentration
Serum 25-hydroxyvitamin D3 (25(OH)D3)Change from baseline in 25(OH)D3 concentration at 4 and 8 weeksThe effect of vitamin D (as form of D3, D2 or D2-fortified bread )supplementation on the serum 25(OH)D3 concentration

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026