Vitamin D DeficiencyNCT01503216
Safety and Bioefficacy of Vitamin D2 and Vitamin D3
A study testing cholecalciferol and ergocalciferol in people with Vitamin D Deficiency, run by Ulrike Lehmann.
Trial summary
The aim of this study is to investigate the bioavailability of vitamin D2 and D3 as measured by the increase of the specific hydroxy forms in serum (25(OH)D2 and 25(OH)D3, respectively, and by total 25(OH)D. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency
- What is being tested?
- cholecalciferol and ergocalciferol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Jan 2012to May 2012
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years
- healthy
Who cannot join
- supplementation of vitamin d and calcium
- hypercalcemia
- hypercalciuria
- chronical illness (diabetes, kidney diseases, cardiovascular diseases)
- serum-creatinine above 115 mmol/l
- pregnancy or breastfeeding women
About this study
Official title: Safety and Bioefficacy of Vitamin D2 and Vitamin D3: Randomized Trial With Human Volunteers
The aim of this study is to investigate the bioavailability of vitamin D2 and D3 as measured by the increase of the specific hydroxy forms in serum (25(OH)D2 and 25(OH)D3, respectively, and by total 25(OH)D.
Read the detailed description
Study design: Human volunteers will receive supplements containing either vitamin D2 or D3 for a period of 8 weeks. At baseline, after 4 weeks and after 8 weeks, 25(OH)D2, 25(OH)D3 and total 25(OH)D will be measured in serum as the main outcome variables. Additional outcome variables are the Ca concentration in serum, PTH concentration in serum, ambulatory blood pressure and heart rate, and renin expression in peripheral mononuclear cells.
Groups/Cohorts Assigned Interventions
- Placebo group
- Vitamin D2-group Daily treatment with vitamin d2-supplements (containing 2000 IU per capsule)
- Vitamin D3-group Daily treatment with vitamin d3-supplements (containing 2000 IU per capsule)
- Conditions
- Vitamin D Deficiency
- Being tested
- cholecalciferol, ergocalciferol, Placebo
- Keywords
- randomized controlled trial, vitamin D, bioavailability
- 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.
cholecalciferolDietary supplement
Also called Cholecalciferol, vitamin D3
cholecalciferol, 2000 IU per day, 8 weeks
ergocalciferolDietary supplement
vitamin d2, 2000 IU per day for 8 weeks
PlaceboDietary supplement
Placebo
| Study group | Role | What they receive |
|---|---|---|
| cholecalciferol | Experimental | Human volunteers receiving cholecalciferol (vitamin D3) for 8 weeks Receives: Dietary Supplement: cholecalciferol |
| Ergocalciferol | Experimental | Ergocalciferol 2000 IU per day for 8 weeks Receives: Dietary Supplement: ergocalciferol |
| Placebo | Placebo comparator | Placebo for 8 weeks Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of 25-hydroxvitamin D
Measured: after 4 and 8 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 posted2 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionMay 2012
- Study completionMay 2012
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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ulrike Lehmann
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ulrike Lehmann, Martin-Luther-Universität Halle-Wittenberg
- Investigators
- Jutta Dierkes, Prof. Dr., Study director, Institut für Agrar- und Ernährungswissenschaften
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01503216
- Sponsor's protocol ID
- BMBF 0315668A
- Status last verified
- Oct 2012
- First submitted
- 24 Oct 2011
- Last updated
- 10 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lehmann U, Hirche F, Stangl GI, Hinz K, Westphal S, Dierkes J. Bioavailability of vitamin D(2) and D(3) in healthy volunteers, a randomized placebo-controlled trial. J Clin Endocrinol Metab. 2013 Nov;98(11):4339-45. doi: 10.1210/jc.2012-4287. Epub 2013 Sep 3.
PubMed 24001747
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Bioefficacy of Vitamin D2 and Vitamin D3: Randomized Trial With Human Volunteers
- ClinicalTrials.gov ID
- NCT01503216
- Acronym / sponsor ID
- BMBF 0315668A
- Conditions
- Vitamin D Deficiency
- Keywords
- randomized controlled trial, vitamin D, bioavailability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Ulrike LehmannUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 2 Jan 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 the bioavailability of vitamin D2 and D3 as measured by the increase of the specific hydroxy forms in serum (25(OH)D2 and 25(OH)D3, respectively, and by total 25(OH)D.
Detailed description
Study design: Human volunteers will receive supplements containing either vitamin D2 or D3 for a period of 8 weeks. At baseline, after 4 weeks and after 8 weeks, 25(OH)D2, 25(OH)D3 and total 25(OH)D will be measured in serum as the main outcome variables. Additional outcome variables are the Ca concentration in serum, PTH concentration in serum, ambulatory blood pressure and heart rate, and renin expression in peripheral mononuclear cells.
Groups/Cohorts Assigned Interventions
- Placebo group
- Vitamin D2-group Daily treatment with vitamin d2-supplements (containing 2000 IU per capsule)
- Vitamin D3-group Daily treatment with vitamin d3-supplements (containing 2000 IU per capsule)
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| cholecalciferol | Experimental | Dietary Supplement: cholecalciferolHuman volunteers receiving cholecalciferol (vitamin D3) for 8 weeks |
| Ergocalciferol | Experimental | Dietary Supplement: ergocalciferolErgocalciferol 2000 IU per day for 8 weeks |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo for 8 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 years
- healthy
Key exclusion criteria (6 listed)
- supplementation of vitamin d and calcium
- hypercalcemia
- hypercalciuria
- chronical illness (diabetes, kidney diseases, cardiovascular diseases)
- serum-creatinine above 115 mmol/l
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 |
|---|---|---|
| cholecalciferolAlso: Cholecalciferol, vitamin D3cholecalciferol, 2000 IU per day, 8 weeks | Dietary supplement | cholecalciferol |
| ergocalciferolvitamin d2, 2000 IU per day for 8 weeks | Dietary supplement | Ergocalciferol |
| PlaceboPlacebo | Dietary supplement | Placebo |
Primary outcome
change of 25-hydroxvitamin D
Time frame: after 4 and 8 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 10 Oct 2012.
- Derived from this study: PubMed 24001747Lehmann U, Hirche F, Stangl GI, Hinz K, Westphal S, Dierkes J. Bioavailability of vitamin D(2) and D(3) in healthy volunteers, a randomized placebo-controlled trial. J Clin Endocrinol Metab. 2013 Nov;98(11):4339-45. doi: 10.1210/jc.2012-4287. Epub 2013 Sep 3.
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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.
Jutta Dierkes, Prof. Dr. study director
Institut für Agrar- und Ernährungswissenschaften
Questions about this trial
What is this clinical trial studying?
A study testing cholecalciferol and ergocalciferol in people with Vitamin D Deficiency, run by Ulrike Lehmann.
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 2 inclusion and 6 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 10 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
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?
change of 25-hydroxvitamin D (time frame: after 4 and 8 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 NCT01503216, 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 10 Oct 2012.