Serum 25-hydroxyvitamin D Concentrations (25OHD)BreaD_ODINNCT02525003
The BreaD Study - Bio-availability of D2 Vitamin Present in Bread
A study testing Vitamin D2, Vitamin D3 and Vitamin D2 fortified bread in people with Serum 25-hydroxyvitamin D Concentrations (25OHD), run by University of Helsinki at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Serum 25-hydroxyvitamin D Concentrations (25OHD)
- What is being tested?
- Vitamin D2, Vitamin D3 and Vitamin D2 fortified bread
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteFinland
- Study dates
- Jan 2014to Apr 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- good general health (no continuous medication),
- Caucasian origin,
- body mass index (BMI) <30 kg/m2
- age 20-40 years
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Finland1 site
Department of Food and Environmental Sciences, University of Helsinki
Helsinki
About this study
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)
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.
- Being tested
- Vitamin D2, Vitamin D3, Vitamin D2 fortified bread
- 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D2Dietary supplement
Experimental group 2: daily vitamin D2 supplement 25ug/d for 8 weeks
Vitamin D3Dietary supplement
Experimental group 3: daily vitamin D3 supplement 25ug/d for 8 weeks
Vitamin D2 fortified breadOther
Experimental group 4: vitamin D2 fortified bread containing 25 µg of vitamin D2/d (bread dose 87g/d) and placebo pill for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: Other: Vitamin D2 fortified bread |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Change from baseline in total 25(OH)D concentration at 4 and 8 weeks
Secondary outcomes (4)
Serum parathyroid hormone (PTH) concentration
The effect of vitamin D (as form of D3, D2 or D2-fortified bread )supplementation on the serum PTH concentration
Measured: Change from baseline in serum PTH concentration at 4 and 8 weeks
Serum calcium concentration
The effect of vitamin D (as form of D3, D2 or D2-fortified bread )supplementation on the serum calcium concentration
Measured: Change from baseline in serum calcium concentration at 4 and 8 weeks
Serum 25-hydroxyvitamin D2 (25(OH)D2)
The effect of vitamin D (as form of D3, D2 or D2-fortified bread )supplementation on the serum 25(OH)D2 concentration
Measured: Change from baseline in 25(OH)D2 concentration at 4 and 8 weeks
Serum 25-hydroxyvitamin D3 (25(OH)D3)
The effect of vitamin D (as form of D3, D2 or D2-fortified bread )supplementation on the serum 25(OH)D3 concentration
Measured: Change from baseline in 25(OH)D3 concentration at 4 and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2015 (estimated)
- Study startJan 2014
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Serum 25-hydroxyvitamin D Concentrations (25OHD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Helsinki
- Sponsor type
- University, hospital or other
- Collaborators
- University College Cork, Technical University of Denmark
- Responsible party
- Principal investigator, Christel Lamberg-Allardt, University of Helsinki
- Investigators
- Christel Lamberg-Allardt, Study director, University of Helsinki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02525003
- Sponsor's protocol ID
- HelsinkiUni
- Acronym
- BreaD_ODIN
- Status last verified
- Aug 2015
- First submitted
- 10 Aug 2015
- Last updated
- 17 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02525003
- Acronym / sponsor ID
- BreaD_ODIN / HelsinkiUni
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University of HelsinkiUniversity, hospital or other
- Collaborators
- University College Cork, Technical University of Denmark
- Study start
- Jan 2014
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 17 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 | Dietary Supplement: Vitamin D2Group 2: daily dose of regular bread (87 g/d) and D2 supplement (25 µg of vitamin D2/d.) for 8 weeks |
| Group 3: Vitamin D3 supplement | Experimental | Dietary Supplement: Vitamin D3Group 3: daily dose of regular bread (87 g/d) and D3 supplement (25 µg of vitamin D3/d.) for 8 weeks |
| Group 4: Vitamin D2-fortified bread | Experimental | Other: Vitamin D2 fortified breadGroup 4: D2 fortified bread containing 25 µg of vitamin D2/d (bread dose 87g/d) and placebo pill for 8 weeks |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- good general health (no continuous medication),
- Caucasian origin,
- body mass index (BMI) <30 kg/m2
- age 20-40 years
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin D2Experimental group 2: daily vitamin D2 supplement 25ug/d for 8 weeks | Dietary supplement | Group 2: Vitamin D2 supplement |
| Vitamin D3Experimental group 3: daily vitamin D3 supplement 25ug/d for 8 weeks | Dietary supplement | Group 3: Vitamin D3 supplement |
| Vitamin D2 fortified breadExperimental group 4: vitamin D2 fortified bread containing 25 µg of vitamin D2/d (bread dose 87g/d) and placebo pill for 8 weeks | Other | Group 4: Vitamin D2-fortified bread |
Primary outcome
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
4 secondary outcomes
Serum parathyroid hormone (PTH) concentration
Time frame: 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
Serum 25-hydroxyvitamin D2 (25(OH)D2)
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2015.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christel Lamberg-Allardt study director
University of Helsinki
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D2, Vitamin D3 and Vitamin D2 fortified bread in people with Serum 25-hydroxyvitamin D Concentrations (25OHD), run by University of Helsinki at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum total 25-hydroxyvitamin D (25(OH)D) (time frame: Change from baseline in total 25(OH)D concentration at 4 and 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2015.