Vitamin D DeficiencyODIN_FOODNCT02631629
Food-based Solutions for Optimal Vitamin D Nutrition and Health
A study testing Non-fortified foods and Fortified foods in people with Vitamin D Deficiency, run by Technical University of Denmark at 1 site in Denmark.
Trial summary
This project aims at proving the efficacy and safety of food based solutions to prevent vitamin D deficiency in high risk populations of Caucasian and South Asian origin living in Denmark. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency
- What is being tested?
- Non-fortified foods and Fortified foods
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 143 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2015to May 2016
- 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 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-50 year old women
- Low consumption of fish and fish products
- Low intake of vitamin D containing supplements
- No use of sunning facilities
- No planned sun-holiday between October 2015 and May 2016
Who cannot join
- Pregnancy and breastfeeding
- Menopause
- Serious diseases (cancer, server liver or kidney insufficiencies, sarcoidosis and other granulomatous diseases) and medicines affecting the vitamin D metabolism (steroids, antiepileptic, thyroid hormones, bisphosphonates, oestrogen).
Trial locations and contacts
1 site in 1 country.
About this study
This project aims at proving the efficacy and safety of food based solutions to prevent vitamin D deficiency in high risk populations of Caucasian and South Asian origin living in Denmark.
Read the detailed description
The study is a 12 week double-blinded, randomised, placebo-controlled food-based intervention trial in a real-life setting. 140 (18-50 y) women in risk of vitamin D deficiency and with Caucasian or South Asian origin. The two ethnic groups of women will each be randomised into two groups. One receiving vitamin D fortified foods and the other receiving the same kind of foods non-fortified. Foods given in the study period are free of charge for the participants and will be handed out every second week. The foods are eggs, yoghurt, cheese and crisp bread.
The study includes a baseline visit and a final visit, at both visits blood samples will be drawn, anthropometrics, muscle strengths, dietary and background questionnaires.
- Conditions
- Vitamin D Deficiency
- Being tested
- Non-fortified foods, Fortified foods
- Keywords
- Vitamin D, Fortification
- Medical subject headings
- Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-fortified foodsOther
The non-fortified placebo foods are eggs, cheese, yoghurt and crisp bread (without vitamin D added).
Fortified foodsOther
The fortified intervention foods are eggs, cheese, yoghurt and crisp bread (with about 20 mcg/day).
| Study group | Role | What they receive |
|---|---|---|
| Non-fortified foods SA | Placebo comparator | Non-fortified foods (eggs, cheese, yoghurt, crips bread) (placebo), women of South Asian (SA) origin Receives: Other: Non-fortified foods |
| Non-fortified foods CA | Placebo comparator | Non-fortified foods (eggs, cheese, yoghurt, crips bread) (placebo), women of Caucasian (CA) origin Receives: Other: Non-fortified foods |
| Vitamin D fortified foods SA | Active comparator | Vitamin D fortified foods (eggs, cheese, yoghurt, crips bread), women of South Asian (SA) origin Receives: Other: Fortified foods |
| Vitamin D fortified foods CA | Active comparator | Vitamin D fortified foods (eggs, cheese, yoghurt, crips bread), women of Caucasian (CA) origin Receives: Other: Fortified foods |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in vitamin D status measured as serum 25-hydroxyvitamin D
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2015 (estimated)
- Study startNov 2015
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vitamin D DeficiencyStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technical University of Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Seventh Framework Programme
- Responsible party
- Principal investigator, Inge Tetens, Technical University of Denmark
- Investigators
- Inge Tetens, Professor, Principal investigator, Technical University of Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02631629
- Sponsor's protocol ID
- H-15008276
- Other IDs
- FP7-613977-ODIN
- Acronym
- ODIN_FOOD
- Status last verified
- Oct 2016
- First submitted
- 11 Nov 2015
- Last updated
- 18 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Gronborg IM, Tetens I, Christensen T, Andersen EW, Jakobsen J, Kiely M, Cashman KD, Andersen R. Vitamin D-fortified foods improve wintertime vitamin D status in women of Danish and Pakistani origin living in Denmark: a randomized controlled trial. Eur J Nutr. 2020 Mar;59(2):741-753. doi: 10.1007/s00394-019-01941-6. Epub 2019 Mar 9.
PubMed 30852657
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Food-based Solutions for Optimal Vitamin D Nutrition and Health
- ClinicalTrials.gov ID
- NCT02631629
- Acronym / sponsor ID
- ODIN_FOOD / H-15008276
- Conditions
- Vitamin D Deficiency
- Keywords
- Vitamin D, Fortification
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- Technical University of DenmarkUniversity, hospital or other
- Collaborators
- Seventh Framework Programme
- Study start
- Nov 2015
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 16 Dec 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.
This project aims at proving the efficacy and safety of food based solutions to prevent vitamin D deficiency in high risk populations of Caucasian and South Asian origin living in Denmark.
Detailed description
The study is a 12 week double-blinded, randomised, placebo-controlled food-based intervention trial in a real-life setting. 140 (18-50 y) women in risk of vitamin D deficiency and with Caucasian or South Asian origin. The two ethnic groups of women will each be randomised into two groups. One receiving vitamin D fortified foods and the other receiving the same kind of foods non-fortified. Foods given in the study period are free of charge for the participants and will be handed out every second week. The foods are eggs, yoghurt, cheese and crisp bread.
The study includes a baseline visit and a final visit, at both visits blood samples will be drawn, anthropometrics, muscle strengths, dietary and background questionnaires.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Non-fortified foods SA | Placebo comparator | Other: Non-fortified foodsNon-fortified foods (eggs, cheese, yoghurt, crips bread) (placebo), women of South Asian (SA) origin |
| Non-fortified foods CA | Placebo comparator | Other: Non-fortified foodsNon-fortified foods (eggs, cheese, yoghurt, crips bread) (placebo), women of Caucasian (CA) origin |
| Vitamin D fortified foods SA | Active comparator | Other: Fortified foodsVitamin D fortified foods (eggs, cheese, yoghurt, crips bread), women of South Asian (SA) origin |
| Vitamin D fortified foods CA | Active comparator | Other: Fortified foodsVitamin D fortified foods (eggs, cheese, yoghurt, crips bread), women of Caucasian (CA) origin |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 18-50 year old women
- Low consumption of fish and fish products
- Low intake of vitamin D containing supplements
- No use of sunning facilities
- No planned sun-holiday between October 2015 and May 2016
Key exclusion criteria (3 listed)
- Pregnancy and breastfeeding
- Menopause
- Serious diseases (cancer, server liver or kidney insufficiencies, sarcoidosis and other granulomatous diseases) and medicines affecting the vitamin D metabolism (steroids, antiepileptic, thyroid hormones, bisphosphonates, oestrogen).
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 |
|---|---|---|
| Non-fortified foodsThe non-fortified placebo foods are eggs, cheese, yoghurt and crisp bread (without vitamin D added). | Other | Non-fortified foods CA, Non-fortified foods SA |
| Fortified foodsThe fortified intervention foods are eggs, cheese, yoghurt and crisp bread (with about 20 mcg/day). | Other | Vitamin D fortified foods CA, Vitamin D fortified foods SA |
Primary outcome
The change in vitamin D status measured as serum 25-hydroxyvitamin D
Time frame: 12 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 18 Oct 2016.
- Derived from this study: PubMed 30852657Gronborg IM, Tetens I, Christensen T, Andersen EW, Jakobsen J, Kiely M, Cashman KD, Andersen R. Vitamin D-fortified foods improve wintertime vitamin D status in women of Danish and Pakistani origin living in Denmark: a randomized controlled trial. Eur J Nutr. 2020 Mar;59(2):741-753. doi: 10.1007/s00394-019-01941-6. Epub 2019 Mar 9.
- Individual participant dataSharing planned: Undecided
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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.
Inge Tetens, Professor principal investigator
Technical University of Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-fortified foods and Fortified foods in people with Vitamin D Deficiency, run by Technical University of Denmark at 1 site in Denmark.
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 5 inclusion and 3 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 18 Oct 2016. 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 Denmark. 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?
The change in vitamin D status measured as serum 25-hydroxyvitamin D (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02631629, which also lists 1 linked publication.
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 18 Oct 2016.