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Completed

NCT Number: NCT02525003

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

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.

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Key information

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of Food and Environmental Sciences, University of Helsinki

Helsinki, Finland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin D2

Dietary Supplement

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

Vitamin D3

Dietary Supplement

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

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

University of Helsinki

Other

Collaborators

  • Technical University of Denmark
  • University College Cork

Registry information

Official study title

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)

Acronym: BreaD_ODIN

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Aug 17, 2015
Registry last updated
Aug 17, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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