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NCT01545830 · ClinicalTrials.gov registry record · Phase 2

Metabolic Syndrome and Insulin Resistance at Allina

A Phase 2 study, sponsored by Allina Health System.

Completed
Registry status
Phase 2
Development phase
84
Enrollment target

NCT01545830: Completed Phase 2 study, sponsored by Allina Health System.

NCT01545830 is a Phase 2 study that has completed, run by Allina Health System. The registered enrollment target is 84 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (37% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01545830, a Phase 2 study, has completed, sponsored by Allina Health System.

COMPLETED
Registry status
Phase 2
Development phase
84 participants
Enrollment target

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.

Primary Outcome

additional insulin resistance measure

Interventions

  • DIETARY_SUPPLEMENT vitamin D3 (cholecalciferol)

Trial Details

FieldValue
Enrollment Target 84 participants
Start Date 2012-03
Est. Completion 2014-03
Phase Phase 2
Allina Health System

32 total trials

What the finished NCT01545830 record still lists

NCT01545830 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 84 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (37% lower).

The record links to 0 conditions, and to 1 intervention - of which vitamin D3 (cholecalciferol) is the first listed.

NCT01545830 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01545830 about?

NCT01545830 is a clinical study titled "Metabolic Syndrome and Insulin Resistance at Allina". 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 cardiovas...

What is the current status of trial NCT01545830?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 84 participants. The study started on 2012-03. Estimated completion is 2014-03.

What interventions are being tested in trial NCT01545830?

The interventions under investigation include: vitamin D3 (cholecalciferol) (DIETARY_SUPPLEMENT).

Who is sponsoring clinical trial NCT01545830?

This trial is sponsored by Allina Health System, which has 32 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01545830's enrollment target sits among peer trials

84 822nd of 2000 higher than 1,173 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01545830, the US trial registry maintained by the National Library of Medicine. NCT01545830 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.