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Isolation of Vitamin D Binding Protein Isoforms From Human Volunteers

NCT ID: NCT02258035

Last Updated: 2024-07-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

24 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-11-30

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Vitamin D Deficiency

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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DBP/Gc1f-1f genotype

Human volunteers homozygous for the 1f-1f (fast) genotype of DBP.

Blood draw

Intervention Type OTHER

Sampling of 100-150 ml of blood

DBP/Gc1s-1s genotype

Human volunteers homozygous for the 1s-1s (slow) genotype of DBP.

Blood draw

Intervention Type OTHER

Sampling of 100-150 ml of blood

DBP/Gc 2-2 genotype

Human volunteers homozygous for the 2-2 genotype of DBP.

Blood draw

Intervention Type OTHER

Sampling of 100-150 ml of blood

Interventions

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Blood draw

Sampling of 100-150 ml of blood

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dirk Vanderschueren, MD PhD

Role: PRINCIPAL_INVESTIGATOR

UZ Leuven

Roger Bouillon, MD PhD

Role: STUDY_CHAIR

UZ Leuven

Hans Wildiers, MD PhD

Role: STUDY_CHAIR

UZ Leuven

Locations

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UZ Leuven

Leuven, , Belgium

Site Status

Countries

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Belgium

References

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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.

Reference Type BACKGROUND
PMID: 22623648 (View on PubMed)

Other Identifiers

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s57027

Identifier Type: -

Identifier Source: org_study_id

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