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Metabolic Syndrome and Insulin Resistance at Allina

NCT01545830 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2016-09-01

No results posted yet for this study

Summary

Vitamin D deficiency is widespread and appears to represent one easily and inexpensively modifiable risk factor for diabetes and cardiovascular disease. More than 40 years of data link hypovitaminosis D to metabolic syndrome, insulin resistance, hyperglycemia, type 2 diabetes and increased cardiovascular risk.

Screening for vitamin D deficiency followed by supplementation in appropriate individuals could be among the simplest and most cost-effective measures for reducing metabolic syndrome and insulin resistance in the general population.

This study will test the hypothesis that increasing vitamin D status in vitamin D deficient individuals with metabolic syndrome will:

1. reduce multiple serum cardiometabolic risk factors for both diabetes and cardiovascular disease,
2. stabilize or reverse the stage of pre-diabetes,
3. improve quality of life, and,
4. improve the ability to make health-related behavioral changes.

Conditions

  • Metabolic Syndrome

Interventions

DIETARY_SUPPLEMENT

vitamin D3 (cholecalciferol)

Active intervention: 6,000 IUs taken by mouth daily for 6 months Active Comparator: 600 IUs taken by mouth daily for 6 months

Sponsors & Collaborators

  • Allina Health System

    lead OTHER

Principal Investigators

  • Gregory Plotnikoff, MD · Allina Health

  • Jeffery Dusek, PhD · Allina Health

  • Shaina Biron · Allina Health

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2014-02-28
Completion
2014-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01545830 on ClinicalTrials.gov