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Vitamin D Binding Protein (Gc) Allele Variation Effects Response to Vitamin D Treatment

NCT ID: NCT00650780

Last Updated: 2008-04-02

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

COMPLETED

Total Enrollment

29 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-10-31

Study Completion Date

2008-01-31

Brief Summary

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We have just completed a randomized, clinical trial of 100,000 IU Vitamin D3 given as a single dose at the beginning of winter. We found a wide range of responses to the dose. This study proposes that genetic differences account for some of the variation in response of 25(OH)D levels after treatment with oral Vitamin D.

Detailed Description

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We suspect that the wide range of response is effected by other factors such as variation in Vitamin D binding protein (the major transporter of Vitamin D metabolites).

Gc, also known as Vitamin D binding protein (DBP), group specific component, or Gc globulin, is a 52-58 kDa multifunctional plasma protein, synthesized in the liver. The gene encoding for Gc is located on chromosome 4, and three common co-dominant alleles give rise to three phenotypes (Gc1s, Gc1f, and Gc2). Gc binds actin, recruits neutrophil leukocytes and converts into a macrophage- and osteoclast- activating factor. It also is the major transporter of Vitamin D and its' metabolites. Lauridsen et al. showed that Gc phenotype correlates with 25(OH)D levels in a group of postmenopausal women.

This study proposes that Gc phenotype accounts for some of the variation in response of 25(OH)D levels after treatment with oral Vitamin D.

Conditions

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Vitamin D Status

Keywords

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Viatmin D, 25-hydroxyvitamin D, Vitamin D binding protein

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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1

All of the subjects will have measurements of Gc concentration and phenotype

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Must be willing to participate with an additional blood draw.
* Must have been in the previous study.

Exclusion Criteria

* Will not be eligible if not a part of the previous study
Minimum Eligible Age

19 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Creighton University

OTHER

Sponsor Role lead

Responsible Party

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Creighton University

Principal Investigators

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Laura Armas, MD

Role: PRINCIPAL_INVESTIGATOR

Creighton University

Locations

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Creighton University

Omaha, Nebraska, United States

Site Status

Countries

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United States

Other Identifiers

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Creighton4

Identifier Type: -

Identifier Source: org_study_id