CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 62 enrolled
Drug / intervention
cholecalciferol +1 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01465178
NCT01465178Phase 3Completed

Improving the Understanding of the Response to Vitamin D Supplementation

University of Wisconsin, Madison·interventional·Posted Nov 4, 2011·Updated Nov 25, 2016

In Brief

A Phase 3 clinical trial evaluating cholecalciferol and Placebo for Vitamin D Deficiency. Completed, enrolled 62 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedNov 4, 2011
Enrollment StartDec 1, 2011
Primary CompletionDec 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 14.7 years ago

Interventions

cholecalciferoldietary

2000 IU cholecalciferol gelcaps by mouth daily

Placebodietary

matching placebo