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

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Serum 25-hydroxyvitamin D Concentrations (25OHD)

Intervention / Treatment
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* Dietary Supplement: Vitamin D2
* Dietary Supplement: Vitamin D3
* Other: Vitamin D2 fortified bread


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Group 1: placebo<br>Group 1: daily dose of regular bread (87 g/d) and placebo pill (0 µg of vitamin D/d) for 8 weeks | |
| Experimental: Group 2: Vitamin D2 supplement<br>Group 2: daily dose of regular bread (87 g/d) and D2 supplement (25 µg of vitamin D2/d.) for 8 weeks | Dietary Supplement: Vitamin D2<br>* Experimental group 2: daily vitamin D2 supplement 25ug/d for 8 weeks<br>|
| Experimental: Group 3: Vitamin D3 supplement<br>Group 3: daily dose of regular bread (87 g/d) and D3 supplement (25 µg of vitamin D3/d.) for 8 weeks | Dietary Supplement: Vitamin D3<br>* Experimental group 3: daily vitamin D3 supplement 25ug/d for 8 weeks<br>|
| Experimental: Group 4: Vitamin D2-fortified bread<br>Group 4: D2 fortified bread containing 25 µg of vitamin D2/d (bread dose 87g/d) and placebo pill for 8 weeks | Other: Vitamin D2 fortified bread<br>* Experimental group 4: vitamin D2 fortified bread containing 25 µg of vitamin D2/d (bread dose 87g/d) and placebo pill for 8 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum total 25-hydroxyvitamin D (25(OH)D) | The effect of vitamin D (as form of D3, D2 or D2-fortified bread )supplementation on the serum 25(OH)D concentration | Change from baseline in total 25(OH)D concentration at 4 and 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum parathyroid hormone (PTH) concentration | The effect of vitamin D (as form of D3, D2 or D2-fortified bread )supplementation on the serum PTH concentration | Change from baseline in serum PTH concentration at 4 and 8 weeks | 
| Serum calcium concentration | The effect of vitamin D (as form of D3, D2 or D2-fortified bread )supplementation on the serum calcium concentration | Change from baseline in serum calcium concentration at 4 and 8 weeks | 
| Serum 25-hydroxyvitamin D2 (25(OH)D2) | The effect of vitamin D (as form of D3, D2 or D2-fortified bread )supplementation on the serum 25(OH)D2 concentration | Change from baseline in 25(OH)D2 concentration at 4 and 8 weeks | 
| Serum 25-hydroxyvitamin D3 (25(OH)D3) | The effect of vitamin D (as form of D3, D2 or D2-fortified bread )supplementation on the serum 25(OH)D3 concentration | Change from baseline in 25(OH)D3 concentration at 4 and 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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