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

August 13, 2015 updated by: Christel Lamberg-Allardt, University of Helsinki

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Helsinki, Finland
        • Department of Food and Environmental Sciences, University of Helsinki

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: 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
EXPERIMENTAL: 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
Dietary supplement: Vitamin D2
Experimental group 2: daily vitamin D2 supplement 25ug/d for 8 weeks
EXPERIMENTAL: 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
Dietary supplement: Vitamin D3
Experimental group 3: daily vitamin D3 supplement 25ug/d for 8 weeks
EXPERIMENTAL: 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
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum total 25-hydroxyvitamin D (25(OH)D)
Time Frame: 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
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
Time Frame: 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
Change from baseline in serum PTH concentration at 4 and 8 weeks
Serum calcium concentration
Time Frame: 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
Change from baseline in serum calcium concentration at 4 and 8 weeks
Serum 25-hydroxyvitamin D2 (25(OH)D2)
Time Frame: 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
Change from baseline in 25(OH)D2 concentration at 4 and 8 weeks
Serum 25-hydroxyvitamin D3 (25(OH)D3)
Time Frame: 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
Change from baseline in 25(OH)D3 concentration at 4 and 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Helsinki

Collaborators

University College Cork
Technical University of Denmark

Investigators

  • Study Director: Christel Lamberg-Allardt, University of Helsinki

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (ACTUAL)

April 1, 2014

Study Completion (ACTUAL)

April 1, 2014

Study Registration Dates

First Submitted

August 10, 2015

First Submitted That Met QC Criteria

August 13, 2015

First Posted (ESTIMATE)

August 17, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

August 17, 2015

Last Update Submitted That Met QC Criteria

August 13, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HelsinkiUni

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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