The Pharmacokinetics of a Single Large Dose of Vitamin D3 (Stoss)

This study has been completed.
Sponsor:
Collaborator:
Procter and Gamble
Information provided by:
Creighton University
ClinicalTrials.gov Identifier:
NCT00473239
First received: May 11, 2007
Last updated: March 30, 2008
Last verified: March 2008
  Purpose

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.


Condition Intervention
Vitamin D Deficiency
Drug: 100,000 IU cholecalciferol.

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Pharmacokinetics of a Single Large Dose of Vitamin D3

Resource links provided by NLM:


Further study details as provided by Creighton University:

Primary Outcome Measures:
  • 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 ]

Enrollment: 40
Study Start Date: October 2006
Study Completion Date: March 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Detailed 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).

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00473239

Locations
United States, Nebraska
Creighton University
Omaha, Nebraska, United States, 68131
Sponsors and Collaborators
Creighton University
Procter and Gamble
Investigators
Principal Investigator: Laura A Armas, MD Creighton University
  More Information

No publications provided by Creighton University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00473239     History of Changes
Other Study ID Numbers: Creighton2
Study First Received: May 11, 2007
Last Updated: March 30, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Creighton University:
vitamin D
cholecalciferol
25-hydroxyvitamin D

Additional relevant MeSH terms:
Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamins
Vitamin D
Cholecalciferol
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on September 30, 2014