Nursing-Home Residents Given Bread Fortified With Vitamin D3

This study has been completed.
Sponsor:
Collaborator:
Natural Ovens of Manitowoc, Manitowoc, USA
Information provided by:
University of Toronto
ClinicalTrials.gov Identifier:
NCT00789503
First received: November 12, 2008
Last updated: NA
Last verified: November 2008
History: No changes posted

November 12, 2008
November 12, 2008
November 2004
December 2005   (final data collection date for primary outcome measure)
Serum 25-hydroxyvitamin D response [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
  • Effects on serum calcium [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Effects on urine calcium [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Change in spine and hip bone mineral density, baseline vs final [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Change in parathyroid hormone, baseline vs final [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Nursing-Home Residents Given Bread Fortified With Vitamin D3
Long-Term Effects of Giving Nursing-Home Residents Bread Fortified With 125 Micrograms (5000 IU) Vitamin D3 Per Daily Serving

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.

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.

Interventional
Phase 1
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Vitamin D Deficiency
  • Low Bone Density
Dietary Supplement: Bread fortified with vitamin D3 and calcium
Bread fortified with vitamin D3 (5000 IU per bun) and calcium
Experimental: Bread fortified with vitamin D3 and calcium
Intervention: Dietary Supplement: Bread fortified with vitamin D3 and calcium

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
45
December 2005
December 2005   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy seniors in an institution in Romania

Exclusion Criteria:

  • Known hypercalcemic or hypercalciuric disease
Both
58 Years to 89 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00789503
Bread Vitamin D
No
Dr Reinhold Vieth, Mount Sinai Hospital, Toronto
University of Toronto
Natural Ovens of Manitowoc, Manitowoc, USA
Not Provided
University of Toronto
November 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP