Clinical Trials Directory

Trials / Completed

CompletedNCT01692028

Identification of the Region of Vitamin D Responsiveness

A Novel Approach Localizes the Association of Vitamin D Status With Insulin Resistance to One Region of the 25(OH)D Continuum.

Status
Completed
Phase
Study type
Observational
Enrollment
4,116 (actual)
Sponsor
Creighton University · Academic / Other
Sex
All
Age
18 Years – 95 Years
Healthy volunteers
Accepted

Summary

Hypothesis: low vitamin D status is associated with increased insulin resistance and increased blood pressure. Approach: Multiple regression analysis of information extracted from a large database accumulated by a Canadian health foundation, specifically evaluating statistical associations between serum 25(OH)D levels and insulin responsiveness measures as well as blood pressure, after adjusting these variables for BMI, age, sex, and waist circumference.

Detailed description

Data obtained from the entry records of 4,116 adult men and women in Calgary,Alberta previously enrolled in the Pure North S'Energy Foundation's health program. Individuals with a clinical diagnosis of diabetes mellitus or a HOMA-IR value above 16 were excluded. Standard statistical analyses carried out. An association between 25(OH)D and the endpoints of interest was first established. The residual values after adjusting HOMA-IR, serum insulin, QUICKI, and blood pressure for BMI, age, sex, and waist circumference were then regressed against serum 25(OH)D using 40-percentile data blocks, stepping upward from the lowest 25(OH)D values by 5 percentile increments through the 7th decile. Regression coefficients are then computed for each data block and each outcome variable. The location (along the 25(OF)D continuum) of the largest and most statistically significant coefficients is noted, and regions of null response noted as well.

Conditions

Timeline

Start date
2012-02-01
Primary completion
2012-02-01
Completion
2012-02-01
First posted
2012-09-25
Last updated
2012-09-25

Locations

1 site across 1 country: Canada

Source: ClinicalTrials.gov record NCT01692028. Inclusion in this directory is not an endorsement.