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

NCT02525003 | Completed

• 1 other identifier: HelsinkiUni
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Serum parathyroid hormone (PTH) concentration

  Change from baseline in serum PTH concentration at 4 and 8 weeks

• Serum calcium concentration

  Change from baseline in serum calcium concentration at 4 and 8 weeks

• Serum 25-hydroxyvitamin D2 (25(OH)D2)

  Change from baseline in 25(OH)D2 concentration at 4 and 8 weeks

• Serum 25-hydroxyvitamin D3 (25(OH)D3)

  Change from baseline in 25(OH)D3 concentration at 4 and 8 weeks

Study Arms (4)

Group 1: placebo

PLACEBO COMPARATOR

Group 1: daily dose of regular bread (87 g/d) and placebo pill (0 µg of vitamin D/d) for 8 weeks

Group 2: Vitamin D2 supplement

EXPERIMENTAL

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

Group 3: Vitamin D3 supplement

EXPERIMENTAL

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

Group 4: Vitamin D2-fortified bread

EXPERIMENTAL

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

Interventions

Vitamin D2 DIETARY_SUPPLEMENT

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

Group 2: Vitamin D2 supplement

Vitamin D3 DIETARY_SUPPLEMENT

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

Group 3: Vitamin D3 supplement

Vitamin D2 fortified bread OTHER

Experimental group 4: vitamin D2 fortified bread containing 25 µg of vitamin D2/d (bread dose 87g/d) and placebo pill for 8 weeks

Group 4: Vitamin D2-fortified bread

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Helsinki: lead
• University College Cork: collaborator
• Technical University of Denmark: collaborator

Study Sites (1)

Department of Food and Environmental Sciences, University of Helsinki

Helsinki, Finland

Location

MeSH Terms

Interventions

Ergocalciferols; Cholecalciferol

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Christel Lamberg-Allardt

  University of Helsinki

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 10, 2015
• First Posted: August 17, 2015
• Study Start: January 1, 2014
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: August 17, 2015

Record last verified: 2015-08

Locations

FI (1)