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Sponsored by: |
Creighton University |
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Information provided by: | Creighton University |
ClinicalTrials.gov Identifier: | NCT00650780 |
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.
Condition |
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Vitamin D Status |
Study Type: | Observational |
Study Design: | Cohort, Cross-Sectional |
Official Title: | Vitamin D Binding Protein (Gc) Allele Variation Effects Response to Vitamin D Treatment |
Enrollment: | 29 |
Study Start Date: | October 2007 |
Study Completion Date: | January 2008 |
Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
Groups/Cohorts |
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1
All of the subjects will have measurements of Gc concentration and phenotype
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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.
Ages Eligible for Study: | 19 Years to 90 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
This study will include thirty males and females who took part in a previous study of a single oral dose of vitamin D.
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Creighton University ( Laura Armas ) |
Study ID Numbers: | Creighton4 |
Study First Received: | March 30, 2008 |
Last Updated: | April 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00650780 |
Health Authority: | United States: Institutional Review Board |
Viatmin D, 25-hydroxyvitamin D, Vitamin D binding protein |
Vitamin D Ergocalciferols Hydroxycholecalciferols |
Growth Substances Vitamins Physiological Effects of Drugs |
Bone Density Conservation Agents Micronutrients Pharmacologic Actions |