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NCT01384539 · ClinicalTrials.gov registry record · Phase 3

Vitamin D and Arterial Function in Patients With Chronic Kidney Disease

A Phase 3 study of Chronic Kidney Disease and Arterial Dysfunction, sponsored by University of Colorado, Denver.

Completed
Registry status
Phase 3
Development phase
128
Enrollment target
1
Study location

NCT01384539: Completed Phase 3 study of Chronic Kidney Disease and Arterial Dysfunction, sponsored by University of Colorado, Denver.

NCT01384539 is a Phase 3 study of Chronic Kidney Disease and Arterial Dysfunction that has completed, run by University of Colorado, Denver. The registered enrollment target is 128 participants, below the 3,206-participant average among 101 other Chronic Kidney Disease trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01384539, a Phase 3 study of Chronic Kidney Disease and Arterial Dysfunction, has completed, sponsored by University of Colorado, Denver.

COMPLETED
Registry status
Phase 3
Development phase
128 participants
Enrollment target
1
Study location

Study Summary

The purpose of this study is to determine whether nutritional (cholecalciferol) or active vitamin D (calcitriol) supplementation improves vascular endothelial function in patients with stage IIIB and IV chronic kidney disease with vitamin D insufficiency or deficiency. The investigators hypothesize that the use of calcitriol supplementation will result in improved vascular endothelial function as compared to cholecalciferol supplementation.

Primary Outcome

EDD will be measured by brachial artery flow-mediated dilation (FMD). The mean change in percent FMD from baseline will be documented.

Interventions

  • DRUG Calcitriol
  • DRUG Cholecalciferol

Study Locations (1)

Colorado

  • University of Colorado Denver Clinical Translational Research Center - Aurora

Trial Details

FieldValue
Enrollment Target 128 participants
Start Date 2011-07
Est. Completion 2015-09
Phase Phase 3
University of Colorado, Denver

1,283 total trials

What the finished NCT01384539 record still lists

NCT01384539 is an interventional study that assigns participants to a tested intervention. The registered 128 participants enrollment target is mid-sized for trials with a published cap, below the 3,206-participant average among 101 other Chronic Kidney Disease trials with a reported enrollment target (96% lower).

The record links to 2 conditions, with Chronic Kidney Disease appearing as the primary indexed condition, and to 2 interventions - of which Calcitriol is the first listed.

NCT01384539 reports a single indexed study location in Colorado.

Frequently Asked Questions

What is clinical trial NCT01384539 about?

NCT01384539 is a clinical study titled "Vitamin D and Arterial Function in Patients With Chronic Kidney Disease". The purpose of this study is to determine whether nutritional (cholecalciferol) or active vitamin D (calcitriol) supplementation improves vascular endothelial function in patients with stage IIIB and IV chronic kidney disease with vitamin D insufficiency or deficiency. The investigators hypothesize ...

What is the current status of trial NCT01384539?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 128 participants. The study started on 2011-07. Estimated completion is 2015-09.

What conditions does trial NCT01384539 study?

This clinical trial studies the following conditions: Chronic Kidney Disease, Arterial Dysfunction.

What interventions are being tested in trial NCT01384539?

The interventions under investigation include: Calcitriol (DRUG), Cholecalciferol (DRUG).

Who is sponsoring clinical trial NCT01384539?

This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01384539 being conducted?

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

Similar trials for Chronic Kidney Disease

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01384539's enrollment target sits among peer trials

128 47th of 101 higher than 54 of 101 other Chronic Kidney Disease trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Chronic Kidney Disease 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 NCT01384539, the US trial registry maintained by the National Library of Medicine. NCT01384539 (mid enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.