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NCT01325610 · ClinicalTrials.gov registry record · NA

Vitamin D Effect on Calcium Absorption on Persons on Hemodialysis

A NA study, sponsored by Creighton University.

Completed
Registry status
NA
Development phase
37
Enrollment target

NCT01325610: Completed NA study, sponsored by Creighton University.

NCT01325610 is a NA study that has completed, run by Creighton University. The registered enrollment target is 37 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01325610, a NA study, has completed, sponsored by Creighton University.

COMPLETED
Registry status
NA
Development phase
37 participants
Enrollment target

Study Summary

The assumption has been that 1,25(OH)2D is solely responsible for calcium absorption. That has been one of the presumed causes of hyperparathyroidism in chronic kidney disease (CKD) (low 1,25(OH)2D leads to decreased calcium absorption, which increases parathyroid hormone release in compensation). Replacing 1,25 D directly has been the goal with using 1,25D or its analogues in CKD. There is very little data concerning use of native vitamin D or 25(OH)D in CKD, although autocrine functions in extrarenal tissues would use 25(OH)D. The latest KDIGO guidelines do recognize the autocrine role of vitamin D, but have no data on outcomes or doses or optimal levels to guide them and so have made a blanket recommendation to treat 25D levels in CKD by general healthy population guidelines. 1. This project focuses on an outcome (calcium absorption) that may be impacted by optimizing 25D status in renal patients. The investigators will assume for this project that a level of 25D \> 32 ng/ml is optimal in CKD patients as in a healthy population. 2. A secondary outcome is to quantify calcium absorption in CKD patients with and without vitamin D repletion and to quantify systemic 1,25D levels. This may clarify the roles 25D and 1,25D play in calcium absorption.

Primary Outcome

A weekly dose of 20,000 IU of vitamin D3 will be taken by the particpant and blood drawn to measure levels at weeks 1, 3, 5, 8, 10, 13, and 18.

Interventions

  • DIETARY_SUPPLEMENT cholecalciferol

Trial Details

FieldValue
Enrollment Target 37 participants
Start Date 2011-04
Est. Completion 2012-02
Phase NA
Creighton University

98 total trials

What the finished NCT01325610 record still lists

NCT01325610 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 37 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).

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

NCT01325610 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01325610 about?

NCT01325610 is a clinical study titled "Vitamin D Effect on Calcium Absorption on Persons on Hemodialysis". The assumption has been that 1,25(OH)2D is solely responsible for calcium absorption. That has been one of the presumed causes of hyperparathyroidism in chronic kidney disease (CKD) (low 1,25(OH)2D leads to decreased calcium absorption, which increases parathyroid hormone release in compensation). R...

What is the current status of trial NCT01325610?

This trial is currently completed. It is a NA study. The enrollment target is 37 participants. The study started on 2011-04. Estimated completion is 2012-02.

What interventions are being tested in trial NCT01325610?

The interventions under investigation include: cholecalciferol (DIETARY_SUPPLEMENT).

Who is sponsoring clinical trial NCT01325610?

This trial is sponsored by Creighton University, which has 98 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01325610's enrollment target sits among peer trials

37 1540th of 2000 higher than 460 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA 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 NCT01325610, the US trial registry maintained by the National Library of Medicine. NCT01325610 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.