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

Not Applicable

Completed

• Conditions: Serum 25-hydroxyvitamin D Concentrations (25OHD)
• Interventions: Other: Vitamin D2 fortified bread; Dietary Supplement: Vitamin D3; Dietary Supplement: Vitamin D2

• Registration Number: NCT02525003
• Lead Sponsor: University of Helsinki

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Status Verified: 2015-08
• Study First Submitted: 2015-08-10
• Study First Submitted QC: 2015-08-13
• Last Update Submitted: 2015-08-13
• Study First Posted: 2015-08-17
• Last Update Posted: 2015-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 41

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 4: Vitamin D2-fortified bread	Vitamin D2 fortified bread	Group 4: D2 fortified bread containing 25 µg of vitamin D2/d (bread dose 87g/d) and placebo pill for 8 weeks
Group 3: Vitamin D3 supplement	Vitamin D3	Group 3: daily dose of regular bread (87 g/d) and D3 supplement (25 µg of vitamin D3/d.) for 8 weeks
Group 2: Vitamin D2 supplement	Vitamin D2	Group 2: daily dose of regular bread (87 g/d) and D2 supplement (25 µg of vitamin D2/d.) for 8 weeks

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Food and Environmental Sciences, University of Helsinki; 🇫🇮 Helsinki, Finland