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

NCT ID: NCT02525003

Last Updated: 2015-08-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2014-04-30

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)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Group 1: placebo

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

Group Type: PLACEBO_COMPARATOR

No interventions assigned to this group

Group 2: Vitamin D2 supplement

Group 2: daily dose of regular bread (87 g/d) and D2 supplement (25 µg of vitamin D2/d.) for 8 weeks

Group Type: EXPERIMENTAL

Vitamin D2

Intervention Type: DIETARY_SUPPLEMENT

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

Group 3: Vitamin D3 supplement

Group 3: daily dose of regular bread (87 g/d) and D3 supplement (25 µg of vitamin D3/d.) for 8 weeks

Group Type: EXPERIMENTAL

Vitamin D3

Intervention Type: DIETARY_SUPPLEMENT

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

Group 4: 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 Type: EXPERIMENTAL

Vitamin D2 fortified bread

Intervention Type: 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

Interventions

Vitamin D2

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

Intervention Type: DIETARY_SUPPLEMENT

Vitamin D3

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

Intervention Type: DIETARY_SUPPLEMENT

Vitamin 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

Intervention Type: OTHER

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University College Cork

OTHER

Sponsor Role: collaborator

Technical University of Denmark

OTHER

Sponsor Role: collaborator

University of Helsinki

OTHER

Sponsor Role: lead

Responsible Party

Christel Lamberg-Allardt

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christel Lamberg-Allardt

Role: STUDY_DIRECTOR

University of Helsinki

Locations

Department of Food and Environmental Sciences, University of Helsinki

Helsinki, , Finland

Countries

Finland

Other Identifiers

HelsinkiUni

Identifier Type: -

Identifier Source: org_study_id