Deficiency of Vitamin D3NCT01711905
Study on the Effects of a Recommendation Based Supply of Vitamin D3 in Healthy Volunteers
A study testing Vitamin D3 in people with Deficiency of Vitamin D3, run by Martin-Luther-Universität Halle-Wittenberg at 1 site in Germany.
Trial summary
The aim of this study is to investigate whether a supplementation of 20 µg Vitamin D3 per day for 12 weeks can be used to normalize vitamin d-Status Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Deficiency of Vitamin D3
- What is being tested?
- Vitamin D3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2012to Apr 2013
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy volunteers
- age between 18 and 70 years
- informed consent
Who cannot join
- use of antihypertensive medication
- use of vitamin d or calcium supplements
- known renal, inflammatory or malignant diseases
- hypercalcemia or hypercalciuria
- participation in other clinical studies
- use of tanning booths during the study
- pregnancy or lactating period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study on the Effects of a Recommendation Based Supply of Vitamin D3 in Healthy Volunteers - a Randomized Trail
The aim of this study is to investigate whether a supplementation of 20 µg Vitamin D3 per day for 12 weeks can be used to normalize vitamin d-Status
Read the detailed description
It is the objective of this study to investigate whether a supplementation with Vitamin D3 can be used to normalize insufficient vitamin d status and reduce atherosclerotic risk factors such as hypertension, inflammation and hyperlipidemia. The research question is whether Vitamin D3 reduces the level of systemic inflammation and whether Vitamin D3 has an effect on blood lipids.
- Conditions
- Deficiency of Vitamin D3
- Being tested
- Vitamin D3
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3Dietary supplement
Also called cholecalciferol
daily dosage of 20 µg Vitamin D3 for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D3 | Experimental | cholecalciferol 20 µg per day for 12 weeks Receives: Dietary Supplement: Vitamin D3 |
| Placebo | No intervention | Placebo for 12 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
25-hydroxyvitamin D3
major outcome variable is the increase of 25-hydroxyvitamin D3 in the treatment group in comparison with the placebo group
Measured: after 12 weeks of supplementation
Secondary outcomes (3)
atherosclerotic risk factors
It is the objective of this study to investigate whether a supplementation with Vitamin D3 can be used to reduce atherosclerotic risk factors such as hypertension, inflammation and hyperlipidemia. The research question is whether Vitamin D3 can reduces the level of systemic inflammation and whether Vitamin D3 has an effect on blood lipids.
Measured: after 12 weeks of supplementation
inflammation
It is the objective of this study to investigate whether a supplementation with Vitamin D3 can be used to reduce inflammation as an atherosclerotic risk factor
Measured: after 12 weeks of supplementation
hyperlipidemia
It is the objective of this study to investigate whether a supplementation with Vitamin D3 can be used to reduce hyperlipidemia as an atherosclerotic risk factor
Measured: after 12 weeks of supplementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2012 (estimated)
- Study startNov 2012
- Primary completionApr 2013
- Study completionApr 2013
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 Deficiency of Vitamin D3Studies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Martin-Luther-Universität Halle-Wittenberg
- Sponsor type
- University, hospital or other
- Collaborators
- German Federal Ministry of Education and Research
- Responsible party
- Principal investigator, Ulrike Lehmann, Martin-Luther-Universität Halle-Wittenberg
- Investigators
- Gabriele I Stangl, Prof. Dr., Study director, Institut für Agrar- und Ernährungswissenschaften
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01711905
- Sponsor's protocol ID
- 0315668
- Status last verified
- Apr 2013
- First submitted
- 15 Oct 2012
- Last updated
- 22 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lehmann U, Riedel A, Hirche F, Brandsch C, Girndt M, Ulrich C, Seibert E, Henning C, Glomb MA, Dierkes J, Stangl GI. Vitamin D3 supplementation: Response and predictors of vitamin D3 metabolites - A randomized controlled trial. Clin Nutr. 2016 Apr;35(2):351-358. doi: 10.1016/j.clnu.2015.04.021. Epub 2015 May 19.
PubMed 26037521
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Effects of a Recommendation Based Supply of Vitamin D3 in Healthy Volunteers - a Randomized Trail
- ClinicalTrials.gov ID
- NCT01711905
- Acronym / sponsor ID
- 0315668
- Conditions
- Deficiency of Vitamin D3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Martin-Luther-Universität Halle-WittenbergUniversity, hospital or other
- Collaborators
- German Federal Ministry of Education and Research
- Study start
- Nov 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 22 Oct 2012 (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.
The aim of this study is to investigate whether a supplementation of 20 µg Vitamin D3 per day for 12 weeks can be used to normalize vitamin d-Status
Detailed description
It is the objective of this study to investigate whether a supplementation with Vitamin D3 can be used to normalize insufficient vitamin d status and reduce atherosclerotic risk factors such as hypertension, inflammation and hyperlipidemia. The research question is whether Vitamin D3 reduces the level of systemic inflammation and whether Vitamin D3 has an effect on blood lipids.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D3 | Experimental | Dietary Supplement: Vitamin D3cholecalciferol 20 µg per day for 12 weeks |
| Placebo | No intervention | –Placebo for 12 weeks |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- healthy volunteers
- age between 18 and 70 years
- informed consent
Key exclusion criteria (7 listed)
- use of antihypertensive medication
- use of vitamin d or calcium supplements
- known renal, inflammatory or malignant diseases
- hypercalcemia or hypercalciuria
- participation in other clinical studies
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 D3Also: cholecalciferoldaily dosage of 20 µg Vitamin D3 for 12 weeks | Dietary supplement | Vitamin D3 |
Primary outcome
25-hydroxyvitamin D3
Time frame: after 12 weeks of supplementation
major outcome variable is the increase of 25-hydroxyvitamin D3 in the treatment group in comparison with the placebo group
3 secondary outcomes
atherosclerotic risk factors
Time frame: after 12 weeks of supplementation
inflammation
Time frame: after 12 weeks of supplementation
hyperlipidemia
Time frame: after 12 weeks of supplementation
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 22 Apr 2013.
- Derived from this study: PubMed 26037521Lehmann U, Riedel A, Hirche F, Brandsch C, Girndt M, Ulrich C, Seibert E, Henning C, Glomb MA, Dierkes J, Stangl GI. Vitamin D3 supplementation: Response and predictors of vitamin D3 metabolites - A randomized controlled trial. Clin Nutr. 2016 Apr;35(2):351-358. doi: 10.1016/j.clnu.2015.04.021. Epub 2015 May 19.
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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.
Gabriele I Stangl, Prof. Dr. study director
Institut für Agrar- und Ernährungswissenschaften
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 in people with Deficiency of Vitamin D3, run by Martin-Luther-Universität Halle-Wittenberg at 1 site in Germany.
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 3 inclusion and 7 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 22 Apr 2013. 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 Germany. 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?
25-hydroxyvitamin D3 (time frame: after 12 weeks of supplementation). 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 NCT01711905, 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 22 Apr 2013.