Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00204919
Status:
COMPLETED
Last Update Posted:
2023-10-04
First Post:
2005-09-13
Brief Title:
Vitamin D Administration in the Nursing Home
Sponsor:
University of Wisconsin Madison
Organization:
University of Wisconsin Madison
Study Overview
Official Title:
Intermittent Vitamin D Administration in the Nursing Home Impact on Vitamin D Status Falls Bone Turnover and Bone Density
Status:
COMPLETED
Status Verified Date:
2015-09
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:
Administration of vitamin D 50000 units once monthly will
Maintain serum 25-OH vitamin D above 20 ngml
Reduce falls
Increase calcaneal BMD
Reduce bone turnover
Be well tolerated volunteers will not develop hypercalcemia
Improve performance on a swallowing quality of life questionnaire
Maintain serum 25-OH vitamin D above 20 ngml
Reduce falls
Increase calcaneal BMD
Reduce bone turnover
Be well tolerated volunteers will not develop hypercalcemia
Improve performance on a swallowing quality of life questionnaire
Detailed Description:
1 Research questions We propose a prospective double-blind randomized placebo-controlled trial of once-monthly vitamin D oral capsules 50000 units in nursing-home residents
Subjects from several Wisconsin nursing homes were randomized to receive once-monthly vitamin D oral capsules 50000 units or placebo Blood levels of 25-OH D parathyroid hormone serum calcium and a marker of bone turnover will be measured periodically by standard lab assays Swallowing quality of life was measured by questionnaire Appropriate statistical tests paired T tests 95 confidence intervals will be calculated with the large sample approximation for binomial variables other
Subjects from several Wisconsin nursing homes were randomized to receive once-monthly vitamin D oral capsules 50000 units or placebo Blood levels of 25-OH D parathyroid hormone serum calcium and a marker of bone turnover will be measured periodically by standard lab assays Swallowing quality of life was measured by questionnaire Appropriate statistical tests paired T tests 95 confidence intervals will be calculated with the large sample approximation for binomial variables other
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