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The Pharmacokinetics of a Single Large Dose of Vitamin D3

NCT00473239 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2015-05-04

No results posted yet for this study

Summary

When people eat a meal, some, but not all of the calcium in that meal is absorbed, that is, moved into the bloodstream. When the skin is exposed to sunlight during summer months, Vitamin D is made there and then modified into more active forms by the liver and kidneys. These more active forms of Vitamin D improve calcium absorption. Many adults living in the U.S. have little or no sun exposure and are low in Vitamin D. A single dose of 100,000 IU of Vitamin D3 has been used both as empiric treatment for Vitamin D deficiency as well as in controlled trials without risk of raising blood calcium to dangerous levels.This study is to determine the serum levels of Vitamin D and 25-hydroxyvitamin D (vitamin D after it has been modified by the liver) that can be expected when Vitamin D3 is given as a single oral dose of 100,000 IU.

Conditions

  • Vitamin D Deficiency

Interventions

DRUG

cholecalciferol.

100,000 IU of Vitamin D

Sponsors & Collaborators

  • Procter and Gamble

    collaborator INDUSTRY

  • Creighton University

    lead OTHER

Principal Investigators

  • Laura A Armas, MD · Creighton University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-10-31
Primary Completion
2007-03-31
Completion
2007-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00473239 on ClinicalTrials.gov