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NCT01465178 · ClinicalTrials.gov registry record · Phase 3

Improving the Understanding of the Response to Vitamin D Supplementation

A Phase 3 study, sponsored by University of Wisconsin, Madison.

Completed
Registry status
Phase 3
Development phase
62
Enrollment target

NCT01465178: Completed Phase 3 study, sponsored by University of Wisconsin, Madison.

NCT01465178 is a Phase 3 study that has completed, run by University of Wisconsin, Madison. The registered enrollment target is 62 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01465178, a Phase 3 study, has completed, sponsored by University of Wisconsin, Madison.

COMPLETED
Registry status
Phase 3
Development phase
62 participants
Enrollment target

Study Summary

It is the investigators hypothesis that the current method of evaluating vitamin D status, measuring circulating 25-hydroxy vitamin D is not providing the full metabolic picture, and is therefore inadequate. The investigators liken this concept to the evolution of cholesterol where initially, total cholesterol was the only measurement, and have since determined the importance of HDL, LDL and triglycerides in evaluating patient status. Similarly, the investigators feel measurement of other vitamin D components such as sulfated vitamin D, circulating vitamin D3 and 3-epi 25-hydroxy vitamin D will offer more comprehensive information about a patient's vitamin D status. It is our overarching hypothesis that a "vitamin D assay panel," will enhance understanding of vitamin D status. It is our expectation that the enhanced understanding based on improved measurement capability will ultimately translate to improved definition of vitamin D status and need for supplementation on an individual level.

Primary Outcome

Our primary outcome variable is the effect of supplementation on change in serum 25(OH)D3;

Interventions

  • DIETARY_SUPPLEMENT Placebo
  • DIETARY_SUPPLEMENT cholecalciferol

Trial Details

FieldValue
Enrollment Target 62 participants
Start Date 2011-12
Est. Completion 2014-12
Phase Phase 3
University of Wisconsin, Madison

1,039 total trials

What the finished NCT01465178 record still lists

NCT01465178 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 62 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT01465178 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01465178 about?

NCT01465178 is a clinical study titled "Improving the Understanding of the Response to Vitamin D Supplementation". It is the investigators hypothesis that the current method of evaluating vitamin D status, measuring circulating 25-hydroxy vitamin D is not providing the full metabolic picture, and is therefore inadequate. The investigators liken this concept to the evolution of cholesterol where initially, total ...

What is the current status of trial NCT01465178?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 62 participants. The study started on 2011-12. Estimated completion is 2014-12.

What interventions are being tested in trial NCT01465178?

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

Who is sponsoring clinical trial NCT01465178?

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

How this trial's enrollment target compares

Where NCT01465178's enrollment target sits among peer trials

62 1802nd of 2000 higher than 198 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 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 NCT01465178, the US trial registry maintained by the National Library of Medicine. NCT01465178 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.