NCT00650780

Brief Summary

We have just completed a randomized, clinical trial of 100,000 IU Vitamin D3 given as a single dose at the beginning of winter. We found a wide range of responses to the dose. This study proposes that genetic differences account for some of the variation in response of 25(OH)D levels after treatment with oral Vitamin D.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2007

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 30, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 2, 2008

Completed
Last Updated

April 2, 2008

Status Verified

March 1, 2008

Enrollment Period

3 months

First QC Date

March 30, 2008

Last Update Submit

April 1, 2008

Conditions

Vitamin D Status

Keywords

Viatmin D, 25-hydroxyvitamin D, Vitamin D binding protein

Outcome Measures

Primary Outcomes (1)

  • Gc concentration and phenotype

    at 1st visit

Study Arms (1)

1

All of the subjects will have measurements of Gc concentration and phenotype

Eligibility Criteria

Age19 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This study will include thirty males and females who took part in a previous study of a single oral dose of vitamin D.

You may qualify if:

  • Must be willing to participate with an additional blood draw.
  • Must have been in the previous study.

You may not qualify if:

  • Will not be eligible if not a part of the previous study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Creighton University

Omaha, Nebraska, 68131, United States

Location

Study Officials

  • Laura Armas, MD

    Creighton University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 30, 2008

First Posted

April 2, 2008

Study Start

October 1, 2007

Primary Completion

January 1, 2008

Study Completion

January 1, 2008

Last Updated

April 2, 2008

Record last verified: 2008-03

Locations

US(1)