Vitamin D StatusVitDNCT02860663
Effect of Different Vitamin D Vitamers on Vitamin D Status
A study testing Vitamin D3, Vitamin D2 and 25OHD in people with Vitamin D Status, run by University of Copenhagen at 1 site in Denmark.
Trial summary
Background: Dietary intake of vitamin D includes vitamin D3 (VitD3), 25-hydroxyvitamin D3 (25OHD3) and vitamin D2 (VitD2). However, the bioactivity of the different species is currently not scientifically established. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Status
- What is being tested?
- Vitamin D3, Vitamin D2 and 25OHD
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2007to Apr 2008
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- No drug use
- BMI< 25 kg/m2
- Do not eat fish more than 2 x weekly
- Not donated blood within 3 months
- No Holiday plans in Winter 2006-2007
Who cannot join
- Any disease
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Nutrition, Exercise and Sports
Frederiksberg, 1958
About this study
Official title: Effect of Different Vitamin D Vitamers on Vitamin D Status and Biomarkers for Bone Health and Cardiovascular Risk in Healthy Humans
Background: Dietary intake of vitamin D includes vitamin D3 (VitD3), 25-hydroxyvitamin D3 (25OHD3) and vitamin D2 (VitD2). However, the bioactivity of the different species is currently not scientifically established.
Objective: The aim of this study was to test the hypothesis that VitD3, 25OHD3 and VitD2 affected vitamin D status equally in humans and if rejected, to estimate the difference in activity.
Design: This study was designed as a 3 x 6 weeks (with 4 weeks run-in) double-blinded randomized cross-over study with 12 young, apparently healthy male volunteers and was performed during wintertime at 55 degree N. during the 4 weeks run-in period all volunteers received 10 ug/d VitD3 in order to achieve steady-state in vitamin D status. During the 3x6 weeks intervention periods the subjects received 10 ug/d VitD3, 10 ug/d 25OHD3 or 10 ug/d VitD2 in random order. Content of vitD3, VitD2, 25OHD3 and 25-hydroxyvitamin D2 (25OHD2) in serum were quantified my LC-MS/MS using 0.1 mL serum.
Read the detailed description
A total of 12 apparently healthy, free living male adults aged 20-30 years were recruited in this 3x6 weeks vitamin D intervention trial. Subjects were recruited among students from the University of Copenhagen through the use of advertisements placed around the University of Copenhagen. Volunteers were excluded if they had BMI > 27 kg/m2, had donated blood within the last three month, has any chronic diseases, used medication regularly, hypercalcemic, had excessive alcohol use, known malabsorption syndromes or used medication known to interfere with vitamin D metabolism. Furthermore, to decrease sun exposure, volunteers who planned to go skiing or travel south during the study was excluded. All subjects were Caucasian, had low habitual fish intake (less than twice a week) and were non-smokers. All subjects were instructed to maintain the same level of physical activity throughout the study and agreed to refrain from donating blood, as well as taking any kind of vitamin, mineral or dietary supplement other than supplements provided in the study. All subjects also agreed to abstain from taking solarium during the intervention. The study was approved by The Local Research Ethics Committee of Copenhagen and Frederiksberg. All participants gave written consent in accordance with the Helsinki declaration.
Design and conduct of study The present study was designed as a double blinded randomised cross over trial in which adult males were assigned to receive tablets containing 10 µg vitD3, 10 µg 25OHD3 and 10 µg vitD2 in random order. Prior to the intervention all subjects received 10 µg vitD3 for 4 weeks in order to achieve steady state in vitamin D status.
The vitamin D tablets (Jette) Compliance was assessed by tablet counting. The study was carried out in Copenhagen, Denmark (latitude 55 degree N). All subjects were recruited in September and run-in periods started in mid-October and the study was finished at the end of March. During the study the subjects were examined at screening, on day 1, 22 and day 42. Blood sample was collected 5 times; before run-in, at baseline, and at end of period, 1, 2 and 3, respectively. Blood samples were drawn after 12 h fasting, in the morning (between 0800 and 0900) by by a trained medical laboratory technician. Subjects were informed not to drink any kind of alcohol and to abstain from hard physical work 24 h before each blood sampling. They were, however, allowed to drink up to ½ L of water. Blood was collected by venipuncture into 10 ml dry tubes for analysis of serum vitamin D, in 5 ml tubes for analysis of serum PTH and in 7 ml Trace element free tubes for analysis of calcium. Blood samples was kept at 20 degree C and centrifuged after 40 min at 3000 g for 15 min. serum was then transferred into plastic tubes and stored at -80 degree C for vitamin d analysis or -20 degree C for Ca and PTH. Anthropometric measures, including height and weight, were taken at baseline. Body weight was measured to nearest 0.1 kg by use of an electronic decimal weight. Subjects were asked to empty their bladder before measuring weight only wearing underwear. The height was measured to nearest cm with the subject standing without shoes, gathering feeds and the head looking forward in horizontal plan.
Habitual intake of calcium and vitamin D was estimated by using a validated food-frequency questionnaire. A health and lifestyle questionnaire, which assessed habitual fish intake, physical activity, general health, smoking status and alcohol consumption, was completed at screening.
Laboratory analysis Serum 25OHD Serum intact parathyroid hormone Serum total calcium
- Conditions
- Vitamin D Status
- Being tested
- Vitamin D3, Vitamin D2, 25OHD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3Dietary supplement
10 ug/d of vitamin D3 for 6 weeks
Vitamin D2Dietary supplement
10 ug/d of vitamin D3 for 6 weeks
25OHDDietary supplement
10 ug/d of vitamin D3 for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D3 | Active comparator | 10 ug/d of vitamin D3 for 6 weeks Receives: Dietary Supplement: Vitamin D3 |
| Vitamin D2 | Active comparator | 10 ug/d of vitamin D2 for 6 weeks Receives: Dietary Supplement: Vitamin D2 |
| 25OHD | Active comparator | 10 ug/ of 25OHD for 6 weeks Receives: Dietary Supplement: 25OHD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum 25OHD
Vitamin D status after intervention with different types of vitamin D
Measured: 1 year
Secondary outcomes (2)
Serum Parathyreoideahormon
Marker for ca status
Measured: 1 year
Serum Ca
Marker for Ca status
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2016 (estimated)
- Study startAug 2007
- Primary completionApr 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin D StatusStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arne Astrup, University of Copenhagen
- Investigators
- Susanne Bügel, Principal investigator, Department of Nutrition, Exercise and Sports
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02860663
- Sponsor's protocol ID
- KF 01 322182
- Acronym
- VitD
- Status last verified
- Oct 2016
- First submitted
- 19 Jul 2016
- Last updated
- 28 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Different Vitamin D Vitamers on Vitamin D Status and Biomarkers for Bone Health and Cardiovascular Risk in Healthy Humans
- ClinicalTrials.gov ID
- NCT02860663
- Acronym / sponsor ID
- VitD / KF 01 322182
- Conditions
- Vitamin D Status
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Study start
- Aug 2007
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 9 Aug 2016 (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.
Background: Dietary intake of vitamin D includes vitamin D3 (VitD3), 25-hydroxyvitamin D3 (25OHD3) and vitamin D2 (VitD2). However, the bioactivity of the different species is currently not scientifically established.
Objective: The aim of this study was to test the hypothesis that VitD3, 25OHD3 and VitD2 affected vitamin D status equally in humans and if rejected, to estimate the difference in activity.
Design: This study was designed as a 3 x 6 weeks (with 4 weeks run-in) double-blinded randomized cross-over study with 12 young, apparently healthy male volunteers and was performed during wintertime at 55 degree N. during the 4 weeks run-in period all volunteers received 10 ug/d VitD3 in order to achieve steady-state in vitamin D status. During the 3x6 weeks intervention periods the subjects received 10 ug/d VitD3, 10 ug/d 25OHD3 or 10 ug/d VitD2 in random order. Content of vitD3, VitD2, 25OHD3 and 25-hydroxyvitamin D2 (25OHD2) in serum were quantified my LC-MS/MS using 0.1 mL serum.
Detailed description
A total of 12 apparently healthy, free living male adults aged 20-30 years were recruited in this 3x6 weeks vitamin D intervention trial. Subjects were recruited among students from the University of Copenhagen through the use of advertisements placed around the University of Copenhagen. Volunteers were excluded if they had BMI > 27 kg/m2, had donated blood within the last three month, has any chronic diseases, used medication regularly, hypercalcemic, had excessive alcohol use, known malabsorption syndromes or used medication known to interfere with vitamin D metabolism. Furthermore, to decrease sun exposure, volunteers who planned to go skiing or travel south during the study was excluded. All subjects were Caucasian, had low habitual fish intake (less than twice a week) and were non-smokers. All subjects were instructed to maintain the same level of physical activity throughout the study and agreed to refrain from donating blood, as well as taking any kind of vitamin, mineral or dietary supplement other than supplements provided in the study. All subjects also agreed to abstain from taking solarium during the intervention. The study was approved by The Local Research Ethics Committee of Copenhagen and Frederiksberg. All participants gave written consent in accordance with the Helsinki declaration.
Design and conduct of study The present study was designed as a double blinded randomised cross over trial in which adult males were assigned to receive tablets containing 10 µg vitD3, 10 µg 25OHD3 and 10 µg vitD2 in random order. Prior to the intervention all subjects received 10 µg vitD3 for 4 weeks in order to achieve steady state in vitamin D status.
The vitamin D tablets (Jette) Compliance was assessed by tablet counting. The study was carried out in Copenhagen, Denmark (latitude 55 degree N). All subjects were recruited in September and run-in periods started in mid-October and the study was finished at the end of March. During the study the subjects were examined at screening, on day 1, 22 and day 42. Blood sample was collected 5 times; before run-in, at baseline, and at end of period, 1, 2 and 3, respectively. Blood samples were drawn after 12 h fasting, in the morning (between 0800 and 0900) by by a trained medical laboratory technician. Subjects were informed not to drink any kind of alcohol and to abstain from hard physical work 24 h before each blood sampling. They were, however, allowed to drink up to ½ L of water. Blood was collected by venipuncture into 10 ml dry tubes for analysis of serum vitamin D, in 5 ml tubes for analysis of serum PTH and in 7 ml Trace element free tubes for analysis of calcium. Blood samples was kept at 20 degree C and centrifuged after 40 min at 3000 g for 15 min. serum was then transferred into plastic tubes and stored at -80 degree C for vitamin d analysis or -20 degree C for Ca and PTH. Anthropometric measures, including height and weight, were taken at baseline. Body weight was measured to nearest 0.1 kg by use of an electronic decimal weight. Subjects were asked to empty their bladder before measuring weight only wearing underwear. The height was measured to nearest cm with the subject standing without shoes, gathering feeds and the head looking forward in horizontal plan.
Habitual intake of calcium and vitamin D was estimated by using a validated food-frequency questionnaire. A health and lifestyle questionnaire, which assessed habitual fish intake, physical activity, general health, smoking status and alcohol consumption, was completed at screening.
Laboratory analysis Serum 25OHD Serum intact parathyroid hormone Serum total calcium
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Vitamin D3 | Active comparator | Dietary Supplement: Vitamin D310 ug/d of vitamin D3 for 6 weeks |
| Vitamin D2 | Active comparator | Dietary Supplement: Vitamin D210 ug/d of vitamin D2 for 6 weeks |
| 25OHD | Active comparator | Dietary Supplement: 25OHD10 ug/ of 25OHD for 6 weeks |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- No drug use
- BMI< 25 kg/m2
- Do not eat fish more than 2 x weekly
- Not donated blood within 3 months
- No Holiday plans in Winter 2006-2007
Key exclusion criteria (1 listed)
- Any disease
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 D310 ug/d of vitamin D3 for 6 weeks | Dietary supplement | Vitamin D3 |
| Vitamin D210 ug/d of vitamin D3 for 6 weeks | Dietary supplement | Vitamin D2 |
| 25OHD10 ug/d of vitamin D3 for 6 weeks | Dietary supplement | 25OHD |
Primary outcome
Serum 25OHD
Time frame: 1 year
Vitamin D status after intervention with different types of vitamin D
2 secondary outcomes
Serum Parathyreoideahormon
Time frame: 1 year
Serum Ca
Time frame: 1 year
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 28 Oct 2016.
- Individual participant dataSharing planned: Yes
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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.
Susanne Bügel principal investigator
Department of Nutrition, Exercise and Sports
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 D3, Vitamin D2 and 25OHD in people with Vitamin D Status, run by University of Copenhagen 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 1 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 28 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. 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 25OHD (time frame: 1 year). 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 28 Oct 2016; AzTrials last refreshed its copy on 7 Nov 2026.