Ignite Creation Date:
2024-05-05 @ 5:31 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00473239
Status:
COMPLETED
Last Update Posted:
2015-05-04
First Post:
2007-05-11
Brief Title:
The Pharmacokinetics of a Single Large Dose of Vitamin D3
Sponsor:
Creighton University
Organization:
Creighton University
Study Overview
Official Title:
The Pharmacokinetics of a Single Large Dose of Vitamin D3
Status:
COMPLETED
Status Verified Date:
2015-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Stoss
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 US have little or no sun exposure and are low in Vitamin D A single dose of 100000 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 levelsThis 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 100000 IU
Detailed Description:
The group receiving the supplement will be scheduled for short visits to our research center at baseline and days 1357 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None