Isolation of Vitamin D Binding Protein Isoforms From Human Volunteers

July 2, 2024 updated by: Universitaire Ziekenhuizen KU Leuven

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

24

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Leuven, Belgium, 3000
        • UZ Leuven

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • Generally healthy adults (≥ 18 years), non pregnant, with known DBP/Gc genotype

Exclusion Criteria:

  • Inability to provide written informed consent
  • No children or pregnant women
  • Persons with known abnormal serum proteins

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
DBP/Gc1f-1f genotype
Human volunteers homozygous for the 1f-1f (fast) genotype of DBP.
Other: Blood draw
Sampling of 100-150 ml of blood
DBP/Gc1s-1s genotype
Human volunteers homozygous for the 1s-1s (slow) genotype of DBP.
Other: Blood draw
Sampling of 100-150 ml of blood
DBP/Gc 2-2 genotype
Human volunteers homozygous for the 2-2 genotype of DBP.
Other: Blood draw
Sampling of 100-150 ml of blood

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
single blood draw at time of consultation, an expected average 4 years after curative treatment for breast cancer

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
In vitro characterization
single blood draw at time of consultation, an expected average 4 years after curative treatment for breast cancer

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitaire Ziekenhuizen KU Leuven

Investigators

  • Principal Investigator: Dirk Vanderschueren, MD PhD, UZ Leuven
  • Study Chair: Roger Bouillon, MD PhD, UZ Leuven
  • Study Chair: Hans Wildiers, MD PhD, UZ Leuven

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Actual)

December 1, 2016

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

September 26, 2014

First Submitted That Met QC Criteria

October 2, 2014

First Posted (Estimated)

October 7, 2014

Study Record Updates

Last Update Posted (Actual)

July 3, 2024

Last Update Submitted That Met QC Criteria

July 2, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • s57027

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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