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NCT01049048 · ClinicalTrials.gov registry record · Early Phase 1

The Effect of Vitamin D Statues on Endothelial Function

A Early Phase 1 study of Cardiovascular Diseases and Vitamin D Deficiency, sponsored by University of Wisconsin, Madison.

Completed
Registry status
Early Phase 1
Development phase
80
Enrollment target
1
Study location

NCT01049048 is a Early Phase 1 study of Cardiovascular Diseases and Vitamin D Deficiency that has completed, run by University of Wisconsin, Madison. The registered enrollment target is 80 participants, below the 26,974-participant average among 300 other Cardiovascular Diseases trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT01049048, a Early Phase 1 study of Cardiovascular Diseases and Vitamin D Deficiency, has completed, sponsored by University of Wisconsin, Madison.

COMPLETED
Registry status
Early Phase 1
Development phase
80 participants
Enrollment target
1
Study location

Study Summary

In the United States, cardiovascular disease causes over one-third of all deaths and vitamin D deficiency is an epidemic. An increasing body of data suggests that low vitamin D status adversely impacts the cardiovascular system. It is our fundamental hypothesis that vitamin D deficiency is a risk factor for cardiovascular disease by causing endothelial dysfunction. Moreover, we hypothesize that vitamin D supplementation will restore endothelial function, thereby reducing cardiovascular disease risk. This pilot research will be conducted in 64 post-menopausal women participating in an existing study of vitamin D supplementation (32 will receive vitamin D3 2,500 IU daily, the others matching placebo) and will explore the effects of vitamin D on endothelial function and arterial reactivity. Post-menopausal women aged 55-65 years are chosen due to their highest risk for development of a subsequent new cardiovascular disease diagnosis. All study participants will have fasting laboratory and noninvasive vascular ultrasound studies performed at baseline and four months later. The primary outcome measure of this pilot study is change in markers of endothelial function and arterial stiffness with vitamin D3 therapy. If our hypotheses are correct, our long-term goals include investigation of the effect of vitamin D repletion on subclinical atherosclerosis and subsequent cardiovascular events.

Interventions

  • DIETARY_SUPPLEMENT Placebo
  • DIETARY_SUPPLEMENT Vitamin D3

Study Locations (1)

Wisconsin

  • University of Wisconsin Osteoporosis Clinical and Research Program - Madison

Trial Details

FieldValue
Enrollment Target 80 participants
Start Date 2009-03
Est. Completion 2010-10
Phase Early Phase 1

Sponsor

University of Wisconsin, Madison

1,039 total trials

What the Registry Record Tells You About NCT01049048

The ClinicalTrials.gov registry entry for NCT01049048 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 26,974-participant average among 300 other Cardiovascular Diseases trials with a reported enrollment target (100% lower). The listed sponsor is University of Wisconsin, Madison, which has 1,039 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Cardiovascular Diseases appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT01049048 reports 1 study location spanning 1 distinct geographic area - top geographies include Wisconsin.

Frequently Asked Questions

What is clinical trial NCT01049048 about?

NCT01049048 is a clinical study titled "The Effect of Vitamin D Statues on Endothelial Function". In the United States, cardiovascular disease causes over one-third of all deaths and vitamin D deficiency is an epidemic. An increasing body of data suggests that low vitamin D status adversely impacts the cardiovascular system. It is our fundamental hypothesis that vitamin D deficiency is a risk fa...

What is the current status of trial NCT01049048?

This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 80 participants. The study started on 2009-03. Estimated completion is 2010-10.

What conditions does trial NCT01049048 study?

This clinical trial studies the following conditions: Cardiovascular Diseases, Vitamin D Deficiency.

What interventions are being tested in trial NCT01049048?

The interventions under investigation include: Placebo (DIETARY_SUPPLEMENT), Vitamin D3 (DIETARY_SUPPLEMENT).

Who is sponsoring clinical trial NCT01049048?

This trial is sponsored by University of Wisconsin, Madison, which has 1,039 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01049048 being conducted?

This trial has 1 study location across Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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