Vitamin D DeficiencyNCT02258035
Isolation of Vitamin D Binding Protein Isoforms From Human Volunteers
An observational study of Vitamin D Deficiency, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
The purpose of this study is to isolate genotype-specific DBP/Gc from homozygous human volunteers and use these purified proteins to cross-validate existing or novel assays for this serum protein and to evaluate the binding characteristics of these variants of DBP/Gc for different vitamin D metabolites. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency
- What is being tested?
- Blood draw
- How many people
- 24 participants
- Where
- 1 siteBelgium
- Study dates
- Nov 2014to Dec 2025
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with known genotype of DBP/Gc, as identified in the clinical database of the Multidisciplinary Breast Centre, University Hospitals Leuven, and free of breast cancer recurrence at the time of blood sampling.
Who may be able to join
- Generally healthy adults (≥ 18 years), non pregnant, with known DBP/Gc genotype
Who cannot join
- Inability to provide written informed consent
- No children or pregnant women
- Persons with known abnormal serum proteins
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Isolation of Genotype-specific Isoforms of Human Vitamin D-binding Protein (DBP/Gc)
The purpose of this study is to isolate genotype-specific DBP/Gc from homozygous human volunteers and use these purified proteins to cross-validate existing or novel assays for this serum protein and to evaluate the binding characteristics of these variants of DBP/Gc for different vitamin D metabolites.
- Conditions
- Vitamin D Deficiency
- Being tested
- Blood draw
- Keywords
- vitamin D binding protein (DBP)
- 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.
Blood drawOther
Sampling of 100-150 ml of blood
| Study group | Role | What they receive |
|---|---|---|
| DBP/Gc1f-1f genotype | Human volunteers homozygous for the 1f-1f (fast) genotype of DBP. Receives: Other: Blood draw | |
| DBP/Gc1s-1s genotype | Human volunteers homozygous for the 1s-1s (slow) genotype of DBP. Receives: Other: Blood draw | |
| DBP/Gc 2-2 genotype | Human volunteers homozygous for the 2-2 genotype of DBP. Receives: Other: Blood draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vitamin D binding protein binding characteristics (affinity constant)
In vitro characterization
Measured: single blood draw at time of consultation, an expected average 4 years after curative treatment for breast cancer
Secondary outcomes (1)
Correlation coefficient (r) of different DBP assays
In vitro characterization
Measured: single blood draw at time of consultation, an expected average 4 years after curative treatment for breast cancer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2014 (estimated)
- Study startNov 2014
- Primary completionDec 2016
- Study completionDec 2025 (estimated)
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.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dirk Vanderschueren, MD PhD, Principal investigator, UZ LeuvenRoger Bouillon, MD PhD, Study chair, UZ LeuvenHans Wildiers, MD PhD, Study chair, UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02258035
- Sponsor's protocol ID
- s57027
- Status last verified
- Jul 2024
- First submitted
- 26 Sep 2014
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
Hatse S, Lambrechts D, Verstuyf A, Smeets A, Brouwers B, Vandorpe T, Brouckaert O, Peuteman G, Laenen A, Verlinden L, Kriebitzsch C, Dieudonne AS, Paridaens R, Neven P, Christiaens MR, Bouillon R, Wildiers H. Vitamin D status at breast cancer diagnosis: correlation with tumor characteristics, disease outcome, and genetic determinants of vitamin D insufficiency. Carcinogenesis. 2012 Jul;33(7):1319-26. doi: 10.1093/carcin/bgs187. Epub 2012 May 23.
PubMed 22623648
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Isolation of Genotype-specific Isoforms of Human Vitamin D-binding Protein (DBP/Gc)
- ClinicalTrials.gov ID
- NCT02258035
- Acronym / sponsor ID
- s57027
- Conditions
- Vitamin D Deficiency
- Keywords
- vitamin D binding protein (DBP)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2025 (estimated)
- First posted
- 7 Oct 2014 (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 purpose of this study is to isolate genotype-specific DBP/Gc from homozygous human volunteers and use these purified proteins to cross-validate existing or novel assays for this serum protein and to evaluate the binding characteristics of these variants of DBP/Gc for different vitamin D metabolites.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| DBP/Gc1f-1f genotype | – | Other: Blood drawHuman volunteers homozygous for the 1f-1f (fast) genotype of DBP. |
| DBP/Gc1s-1s genotype | – | Other: Blood drawHuman volunteers homozygous for the 1s-1s (slow) genotype of DBP. |
| DBP/Gc 2-2 genotype | – | Other: Blood drawHuman volunteers homozygous for the 2-2 genotype of DBP. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with known genotype of DBP/Gc, as identified in the clinical database of the Multidisciplinary Breast Centre, University Hospitals Leuven, and free of breast cancer recurrence at the time of blood sampling.
Key inclusion criteria (1 listed)
- Generally healthy adults (≥ 18 years), non pregnant, with known DBP/Gc genotype
Key exclusion criteria (3 listed)
- Inability to provide written informed consent
- No children or pregnant women
- Persons with known abnormal serum proteins
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 |
|---|---|---|
| Blood drawSampling of 100-150 ml of blood | Other | DBP/Gc 2-2 genotype, DBP/Gc1f-1f genotype, DBP/Gc1s-1s genotype |
Primary outcome
Vitamin D binding protein binding characteristics (affinity constant)
Time frame: single blood draw at time of consultation, an expected average 4 years after curative treatment for breast cancer
In vitro characterization
1 secondary outcome
Correlation coefficient (r) of different DBP assays
Time frame: single blood draw at time of consultation, an expected average 4 years after curative treatment for breast cancer
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Background: PubMed 22623648Hatse S, Lambrechts D, Verstuyf A, Smeets A, Brouwers B, Vandorpe T, Brouckaert O, Peuteman G, Laenen A, Verlinden L, Kriebitzsch C, Dieudonne AS, Paridaens R, Neven P, Christiaens MR, Bouillon R, Wildiers H. Vitamin D status at breast cancer diagnosis: correlation with tumor characteristics, disease outcome, and genetic determinants of vitamin D insufficiency. Carcinogenesis. 2012 Jul;33(7):1319-26. doi: 10.1093/carcin/bgs187. Epub 2012 May 23.
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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.
Dirk Vanderschueren, MD PhD principal investigator
UZ Leuven
Roger Bouillon, MD PhD study chair
UZ Leuven
Hans Wildiers, MD PhD study chair
UZ Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vitamin D Deficiency, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 1 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: status not confirmed, as of the sponsor's last update on 3 Jul 2024. 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 Belgium. 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?
Results are not available in the source record.
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?
Vitamin D binding protein binding characteristics (affinity constant) (time frame: single blood draw at time of consultation, an expected average 4 years after curative treatment for breast cancer). 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 NCT02258035, 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 3 Jul 2024.