Ignite Creation Date:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2025-12-27 @ 5:43 PM
Study NCT ID:
NCT00491920
Status:
COMPLETED
Last Update Posted:
2011-11-03
First Post:
2007-06-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
High Dosage Vitamin D and Osteoporosis
Sponsor:
University Hospital of North Norway
Organization:
Study Overview
Official Title:
High Dosage Vitamin D in the Treatment of Osteoporosis in Postmenopausal Women
Status:
COMPLETED
Status Verified Date:
2011-11
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:
None
Brief Summary:
Vitamin D and calcium are essential in the treatment and prevention of osteoporosis. What dosage of vitamin D which is the ideal one, is not yet clear. We want to test the hypothesis that high dosage of vitamin D (i.e. 6500 IU/d) is better than standard dosage (800 IU/d) in a randomized double-blind trial. We will include 400 postmenopausal otherwise healthy women with T-score \<= -2.0 in L2-4 or mean total hip. Everybody will receive calcium 1000 mg and vitamin D 800 IU every day. Half of the group will also receive vitamin D 40 000 IU/week, while the other half will have placebo. The study period is one year.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: