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

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ClinicalTrials.gov Identifier: NCT02525003
Recruitment Status : Completed
First Posted : August 17, 2015
Last Update Posted : August 17, 2015
Sponsor:
Collaborators:
University College Cork
Technical University of Denmark
Information provided by (Responsible Party):
Christel Lamberg-Allardt, 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.

Condition or disease Intervention/treatment Phase
Serum 25-hydroxyvitamin D Concentrations (25OHD) Dietary Supplement: Vitamin D2 Dietary Supplement: Vitamin D3 Other: Vitamin D2 fortified bread Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official 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)
Study Start Date : January 2014
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D

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




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02525003


Locations
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Finland
Department of Food and Environmental Sciences, University of Helsinki
Helsinki, Finland
Sponsors and Collaborators
University of Helsinki
University College Cork
Technical University of Denmark
Investigators
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Study Director: Christel Lamberg-Allardt University of Helsinki
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Responsible Party: Christel Lamberg-Allardt, Professor, University of Helsinki
ClinicalTrials.gov Identifier: NCT02525003    
Other Study ID Numbers: HelsinkiUni
First Posted: August 17, 2015    Key Record Dates
Last Update Posted: August 17, 2015
Last Verified: August 2015
Keywords provided by Christel Lamberg-Allardt, University of Helsinki:
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
Additional relevant MeSH terms:
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Vitamin D
Ergocalciferols
Cholecalciferol
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents