The Pharmacokinetics of a Single Large Dose of Vitamin D3
Stoss
1 other identifier
interventional
40
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2006
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2007
CompletedFirst Submitted
Initial submission to the registry
May 11, 2007
CompletedFirst Posted
Study publicly available on registry
May 15, 2007
CompletedMay 4, 2015
April 1, 2015
5 months
May 11, 2007
April 30, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
to assess the time course and response of serum 25-OHD with a single oral dose of 100,000 IU cholecalciferol.
4 months
Study Arms (2)
cholecalciferol
EXPERIMENTALA single dose of 100,000 IU vitamin D
Control
NO INTERVENTIONNo drug was given
Interventions
Eligibility Criteria
You may qualify if:
- healthy with limited sun exposure of less than 10 hours per week and daily milk consumption of less than 0.47 L (16 oz.).
You may not qualify if:
- those with granulomatous conditions, liver disease, kidney disease, or diabetes and those taking anticonvulsants, barbiturates, or steroids in any form.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Creighton Universitylead
- Procter and Gamblecollaborator
Study Sites (1)
Creighton University
Omaha, Nebraska, 68131, United States
Related Publications (1)
Ilahi M, Armas LA, Heaney RP. Pharmacokinetics of a single, large dose of cholecalciferol. Am J Clin Nutr. 2008 Mar;87(3):688-91. doi: 10.1093/ajcn/87.3.688.
PMID: 18326608DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Laura A Armas, MD
Creighton University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 11, 2007
First Posted
May 15, 2007
Study Start
October 1, 2006
Primary Completion
March 1, 2007
Study Completion
March 1, 2007
Last Updated
May 4, 2015
Record last verified: 2015-04