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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01771380
First Posted: January 18, 2013
Last Update Posted: September 22, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Tromso
  Purpose
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.

Condition
Impaired Glucose Tolerance

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Measurement of the Free Fraction of 25-hydroxyvitamin D in Serum

Resource links provided by NLM:


Further study details as provided by University of Tromso:

Primary Outcome Measures:
  • Free fraction of 25(OH)D [ Time Frame: 1 day ]

Secondary Outcome Measures:
  • DBP polymorphisms [ Time Frame: 1 day ]

Other Outcome Measures:
  • RNA expression in peripheral blood [ Time Frame: 1 day ]

Enrollment: 78
Study Start Date: February 2013
Study Completion Date: August 2015
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Subjects with impaired glucose tolerance

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Subjects with known impaired glucose tolerance
Criteria

Inclusion Criteria:

  • Impaired glucose tolerance
  • living in the Tromsø area

Exclusion Criteria

  • pregnancy
  • serious illness
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01771380


Locations
Norway
University of Tromsø
Tromsø, Norway, 9037
Sponsors and Collaborators
University of Tromso
  More Information

Responsible Party: University of Tromso
ClinicalTrials.gov Identifier: NCT01771380     History of Changes
Other Study ID Numbers: Tromsø-Endo-2013-1
First Submitted: January 10, 2013
First Posted: January 18, 2013
Last Update Posted: September 22, 2015
Last Verified: September 2015

Additional relevant MeSH terms:
Glucose Intolerance
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Hydroxycholecalciferols
Calcifediol
Vitamin D
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents