The Pharmacokinetics of a Single Large Dose of Vitamin D3

Vitamin D Deficiency Clinical Trial

— Stoss  

Official title:

The Pharmacokinetics of a Single Large Dose of Vitamin D3

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00473239
• Other study ID #: Creighton2
• Status: Completed
• Phase: N/A
• First received: May 11, 2007
• Last updated: April 30, 2015
• Start date: October 2006
• Est. completion date: March 2007

Study information

• Verified date: April 2015
• Source: Creighton University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 2007
• Est. primary completion date: March 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 19 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Vitamin D Deficiency

Intervention

Drug:
• cholecalciferol.
100,000 IU of Vitamin D

Locations

Country	Name	City	State
United States	Creighton University	Omaha	Nebraska

Sponsors (2)

Lead Sponsor	Collaborator
Creighton University	Procter and Gamble

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	to assess the time course and response of serum 25-OHD with a single oral dose of 100,000 IU cholecalciferol.		4 months