Isolation of Vitamin D Binding Protein Isoforms From Human Volunteers

Vitamin D Deficiency Clinical Trial

Official title:

Isolation of Genotype-specific Isoforms of Human Vitamin D-binding Protein (DBP/Gc)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02258035
• Other study ID #: s57027
• Status: Active, not recruiting
• Start date: November 2014
• Est. completion date: December 2020

Study information

• Verified date: May 2018
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 24
• Est. completion date: December 2020
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Vitamin D Deficiency

Intervention

Other:
• Blood draw
Sampling of 100-150 ml of blood

Locations

Country	Name	City	State
Belgium	UZ Leuven	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

References & Publications (1)

Hatse S, Lambrechts D, Verstuyf A, Smeets A, Brouwers B, Vandorpe T, Brouckaert O, Peuteman G, Laenen A, Verlinden L, Kriebitzsch C, Dieudonné 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vitamin D binding protein binding characteristics (affinity constant)	In vitro characterization	single blood draw at time of consultation, an expected average 4 years after curative treatment for breast cancer
Secondary	Correlation coefficient (r) of different DBP assays	In vitro characterization	single blood draw at time of consultation, an expected average 4 years after curative treatment for breast cancer