|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||||||||||||||
| Sponsors and Collaborators: |
Creighton University Procter and Gamble |
|---|---|
| Information provided by: | Creighton University |
| ClinicalTrials.gov Identifier: | NCT00473239 |
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: | Treatment, Randomized, Open Label, Placebo Control, Single Group Assignment, Pharmacodynamics Study |
| Official Title: | The Pharmacokinetics of a Single Large Dose of Vitamin D3 |
| 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) |
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Nebraska | |
| Creighton University | |
| Omaha, Nebraska, United States, 68131 | |
| Principal Investigator: | Laura A Armas, MD | Creighton University |
More Information
| Study ID Numbers: | Creighton2 |
| Study First Received: | May 11, 2007 |
| Last Updated: | March 30, 2008 |
| ClinicalTrials.gov Identifier: | NCT00473239 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
vitamin D cholecalciferol 25-hydroxyvitamin D |
|
Vitamin D Deficiency Cholecalciferol Avitaminosis Trace Elements Bone Density Conservation Agents Hydroxycholecalciferols Malnutrition |
Vitamin D Vitamin D3 Vitamins Nutrition Disorders Micronutrients Calciferol Deficiency Diseases |
|
Vitamin D Deficiency Cholecalciferol Avitaminosis Growth Substances Physiological Effects of Drugs Bone Density Conservation Agents Pharmacologic Actions |
Malnutrition Vitamin D Vitamins Nutrition Disorders Micronutrients Deficiency Diseases |
