The Variability of 25-hydroxyvitamin D Response From Crystalline 25-hydroxyvitamin D3

May 27, 2013 updated by: Creighton University

The Variability of 25-hydroxyvitamin D Response From Crystalline 25-hydroxyvitamin D3 Compared to Native Vitamin D3: A Short Term Pharmacokinetic Study

The investigators hypothesize that native vitamin D will have more variability in 25(OH)D dose response when compared to a given equipotent dose of 25-hydroxyvitamin D3. This will be a single blind, active control, pharmacokinetic study of 625 μg 25(OH)D given orally or 2500 μg native vitamin D given orally.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Single blind, active control, pharmacokinetic study of 625 μg 25(OH)D given orally or 2500 μg native vitamin D given orally.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Nebraska
      • Omaha, Nebraska, United States, 68131
        • Creighton University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Ten men and women in each group,
  • aged 20-60.

Exclusion Criteria:

  • History of hypercalcemia,
  • vitamin D supplement use > 800 IU daily,
  • BMI > 30,
  • gastrointestinal malabsorption (from celiac sprue, colitis, surgery, etc.), kidney disease or liver disease,
  • use of steroids in any form,
  • anticonvulsants,
  • antibiotics,
  • acute illness, or
  • vacation planned to "sunny climate"

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Vitamin D Cholecalciferol
A single dose of 2500 micrograms cholecalciferol
Dietary supplement: cholecalciferol
a single dose of 2500 micrograms of cholecalciferol
Experimental: 25(OH)D
A single dose of 625 micrograms 25(OH)D
Dietary supplement: 25(OH)D
a single dose of 625 micrograms of 25(OH)D

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum 25(OH)D response
Time Frame: 28 days
25(OH)D will be measured at frequent time intervals over 28 days.
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Creighton University

Investigators

  • Principal Investigator: Laura Armas, MD,MS, Creighton University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Anticipated)

November 1, 2013

Study Completion (Anticipated)

November 1, 2013

Study Registration Dates

First Submitted

July 2, 2012

First Submitted That Met QC Criteria

July 3, 2012

First Posted (Estimate)

July 4, 2012

Study Record Updates

Last Update Posted (Estimate)

May 29, 2013

Last Update Submitted That Met QC Criteria

May 27, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Creighton 13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Vitamin D Deficiency

Clinical Trials on cholecalciferol

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mauritius

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe