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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01692028
Acronym
GRH-PN01
Enrollment
4116
Registered
2012-09-25
Start date
2012-02-29
Completion date
2012-02-29
Last updated
2012-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Hypertension

Keywords

vitamin D, Associational study

Brief 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.

Interventions

None listed

Sponsors

Creighton University
Lead SponsorOTHER

Study design

Observational model
ECOLOGIC_OR_COMMUNITY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 95 Years
Healthy volunteers
Yes

Inclusion criteria

* Age \> 18

Exclusion criteria

* Diabetes * Elevated HOMA-IR (\>16)

Design outcomes

Primary

MeasureTime frameDescription
HOMA-IRObservational/cross-sectional studyA composite measure of insulin resistance (HOMA-IR)

Secondary

MeasureTime frameDescription
Blood pressurecross-sectional studyBlood Pressure

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026