Nursing-Home Residents Given Bread Fortified With Vitamin D3
Sponsor
University of Toronto (Other)
Overall Status
Completed
CT.gov ID
NCT00789503
Collaborator
Natural Ovens of Manitowoc, Manitowoc, USA (Other)
45
1
13
Study Details
Study Description
Brief Summary
Background. For older adults, serum 25-hydroxyvitamin D (25(OH)D) higher than 75 nmol/L lowers fracture risk and attainment of this 25(OH)D target may require 125 mcg (5000 IU)/d of vitamin D3.
Objective: We wanted to characterize the safety and efficacy of fortifying bread with a biologically meaningful amount of vitamin D3.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1/Phase 2 |
Detailed Description
Methods: In a single-arm design, 45 nursing-home residents consumed one bun/d that had been fortified with 125 mcg (5,000 IU) of vitamin D3 and 320 mg elemental calcium.
Study Design
Study Type:
Interventional
Actual Enrollment
:
45 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Long-Term Effects of Giving Nursing-Home Residents Bread Fortified With 125 Micrograms (5000 IU) Vitamin D3 Per Daily Serving
Study Start Date
:
Nov 1, 2004
Actual Primary Completion Date
:
Dec 1, 2005
Actual Study Completion Date
:
Dec 1, 2005
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Bread fortified with vitamin D3 and calcium
|
Dietary Supplement: Bread fortified with vitamin D3 and calcium
Bread fortified with vitamin D3 (5000 IU per bun) and calcium
|
Outcome Measures
Primary Outcome Measures
- Serum 25-hydroxyvitamin D response [12 months]
Secondary Outcome Measures
- Effects on serum calcium [12 months]
- Effects on urine calcium [12 months]
- Change in spine and hip bone mineral density, baseline vs final [12 months]
- Change in parathyroid hormone, baseline vs final [12 months]
Eligibility Criteria
Criteria
Ages Eligible for Study:
58 Years
to 89 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
- Healthy seniors in an institution in Romania
Exclusion Criteria:
- Known hypercalcemic or hypercalciuric disease
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- University of Toronto
- Natural Ovens of Manitowoc, Manitowoc, USA
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00789503
Other Study ID Numbers:
- Bread Vitamin D
First Posted:
Nov 13, 2008
Last Update Posted:
Nov 13, 2008
Last Verified:
Nov 1, 2008
Keywords provided by ,
,
Additional relevant MeSH terms: