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NCT01771380 Clinical Trial

Measurement of the Free Fraction of 25-hydroxyvitamin D in Serum

Impaired Glucose Tolerance Clinical Trial

Official title:
Measurement of the Free Fraction of 25-hydroxyvitamin D in Serum

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01771380
Other study ID # Tromsø-Endo-2013-1
Secondary ID
Status Completed
Phase N/A
First received January 10, 2013
Last updated September 18, 2015
Start date February 2013
Est. completion date August 2015

Study information
Verified date September 2015
Source University of Tromso
Contact n/a
Is FDA regulated No
Health authority Norway:National Committee for Medical and Health Research Ethics
Study type Observational

Clinical Trial Summary

In the circulation 25-hydroxyvitaminD (25(OH)D) is bound to the vitamin D binding protein (DBP) and albumin. According to the free hormone hypothesis, it is, however, the free fraction that is biologically active. Polymorphisms in DBP are related to the serum level of 25(OH)D. As these polymorphisms may also affect the binding affinities for 25(OH)D, the total serum 25(OH)D may not necessary reflect the free fraction. To test this hypothesis, we will calculate the free fraction of 25(OH)D by correction for DBP and albumin content, and also measure free 25(OH)D from equilibrium dialysis and ultra filtration. Furthermore, we will relate total serum 25(OH)D as well as the free and biologically active (free- albumin-bound) 25(OH)D to the well established vitamin D effect marker serum parathyroid hormone as well as to the RNA expression in peripheral blood to evaluate the biological importance of the free versus the total fraction of 25(OH)D. We will invite 300 subjects from an ongoing vitamin D supplementation study to participate in the study which will be one visit only and include collection of blood samples.

Recruitment information / eligibility
Status Completed
Enrollment 78
Est. completion date August 2015
Est. primary completion date June 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 25 Years to 85 Years
Eligibility Inclusion Criteria:

- Impaired glucose tolerance

- living in the Tromsø area

Exclusion Criteria

- pregnancy

- serious illness

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

Locations
Country Name City State
Norway University of Tromsø Tromsø

Sponsors (1)
Lead Sponsor Collaborator
University of Tromso

Country where clinical trial is conducted

Norway, 

Outcome
Type Measure Description Time frame Safety issue
Other RNA expression in peripheral blood 1 day No
Primary Free fraction of 25(OH)D 1 day No
Secondary DBP polymorphisms 1 day No
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