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The Pharmacokinetics of a Single Large Dose of Vitamin D3 (Stoss)
This study has been completed.
Study NCT00473239   Information provided by Creighton University
First Received: May 11, 2007   Last Updated: March 30, 2008   History of Changes

May 11, 2007
March 30, 2008
October 2006
March 2007   (final data collection date for primary outcome measure)
to assess the time course and response of serum 25-OHD with a single oral dose of 100,000 IU cholecalciferol. [ Time Frame: 4 months ]
Same as current
Complete list of historical versions of study NCT00473239 on ClinicalTrials.gov Archive Site
 
 
 
The Pharmacokinetics of a Single Large Dose of Vitamin D3
The Pharmacokinetics of a Single Large Dose of Vitamin D3

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.

The group receiving the supplement will be scheduled for short visits to our research center at baseline and days 1,3,5,7 and then weekly for 3 weeks and then every other week for 6 visits (total 14 visits in 4 months). The group not receiving supplement will be scheduled for short visits at baseline and in 4 months. At the beginning of the study we will measure your height, weight, skin color, and draw blood to measure your blood levels of Vitamin D, 25-hydroxyvitamin D, calcium and parathyroid hormone. At each visit we will draw blood to measure your blood levels of Vitamin D and 25-hydroxyvitamin D. There will be fourteen blood draws for a total of 280 cc of blood drawn (about 4 teaspoons drawn each time) in the supplemented group. There will be 2 blood draws in the group not receiving supplements for a total of 60 cc of blood drawn (about 4 teaspoons drawn each time).

 
Interventional
Treatment, Randomized, Open Label, Placebo Control, Single Group Assignment, Pharmacodynamics Study
Vitamin D Deficiency
Drug: 100,000 IU cholecalciferol.
 
Ilahi M, Armas LA, Heaney RP. Pharmacokinetics of a single, large dose of cholecalciferol. Am J Clin Nutr. 2008 Mar;87(3):688-91.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
40
March 2007
March 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • healthy with limited sun exposure of less than 10 hours per week and daily milk consumption of less than 0.47 L (16 oz.).

Exclusion Criteria:

  • those with granulomatous conditions, liver disease, kidney disease, or diabetes and those taking anticonvulsants, barbiturates, or steroids in any form.
Both
19 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00473239
 
Creighton2
Creighton University
Procter and Gamble
Principal Investigator: Laura A Armas, MD Creighton University
Creighton University
March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP