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Nursing-Home Residents Given Bread Fortified With Vitamin D3

Primary Purpose

Vitamin D Deficiency, Low Bone Density

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Bread fortified with vitamin D3 and calcium
Sponsored by
University of Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vitamin D Deficiency focused on measuring dietary fortification, Vitamin D3, Osteomalacia, bread, bone mineral density, geriatrics, cholecalciferol, calcidiol, osteoporosis, dual-energy photon absorptiometry, bread fortification

Eligibility Criteria

58 Years - 89 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy seniors in an institution in Romania

Exclusion Criteria:

  • Known hypercalcemic or hypercalciuric disease

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Bread fortified with vitamin D3 and calcium

    Arm Description

    Outcomes

    Primary Outcome Measures

    Serum 25-hydroxyvitamin D response

    Secondary Outcome Measures

    Effects on serum calcium
    Effects on urine calcium
    Change in spine and hip bone mineral density, baseline vs final
    Change in parathyroid hormone, baseline vs final

    Full Information

    First Posted
    November 12, 2008
    Last Updated
    November 12, 2008
    Sponsor
    University of Toronto
    Collaborators
    Natural Ovens of Manitowoc, Manitowoc, USA
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00789503
    Brief Title
    Nursing-Home Residents Given Bread Fortified With Vitamin D3
    Official Title
    Long-Term Effects of Giving Nursing-Home Residents Bread Fortified With 125 Micrograms (5000 IU) Vitamin D3 Per Daily Serving
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2008
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2004 (undefined)
    Primary Completion Date
    December 2005 (Actual)
    Study Completion Date
    December 2005 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    University of Toronto
    Collaborators
    Natural Ovens of Manitowoc, Manitowoc, USA

    4. Oversight

    Data Monitoring Committee
    No

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Vitamin D Deficiency, Low Bone Density
    Keywords
    dietary fortification, Vitamin D3, Osteomalacia, bread, bone mineral density, geriatrics, cholecalciferol, calcidiol, osteoporosis, dual-energy photon absorptiometry, bread fortification

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    45 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Bread fortified with vitamin D3 and calcium
    Arm Type
    Experimental
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Bread fortified with vitamin D3 and calcium
    Intervention Description
    Bread fortified with vitamin D3 (5000 IU per bun) and calcium
    Primary Outcome Measure Information:
    Title
    Serum 25-hydroxyvitamin D response
    Time Frame
    12 months
    Secondary Outcome Measure Information:
    Title
    Effects on serum calcium
    Time Frame
    12 months
    Title
    Effects on urine calcium
    Time Frame
    12 months
    Title
    Change in spine and hip bone mineral density, baseline vs final
    Time Frame
    12 months
    Title
    Change in parathyroid hormone, baseline vs final
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    58 Years
    Maximum Age & Unit of Time
    89 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Healthy seniors in an institution in Romania Exclusion Criteria: Known hypercalcemic or hypercalciuric disease

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    24120120
    Citation
    Mocanu V, Vieth R. Three-year follow-up of serum 25-hydroxyvitamin D, parathyroid hormone, and bone mineral density in nursing home residents who had received 12 months of daily bread fortification with 125 mug of vitamin D(3). Nutr J. 2013 Oct 11;12:137. doi: 10.1186/1475-2891-12-137.
    Results Reference
    derived
    PubMed Identifier
    19244376
    Citation
    Mocanu V, Stitt PA, Costan AR, Voroniuc O, Zbranca E, Luca V, Vieth R. Long-term effects of giving nursing home residents bread fortified with 125 microg (5000 IU) vitamin D(3) per daily serving. Am J Clin Nutr. 2009 Apr;89(4):1132-7. doi: 10.3945/ajcn.2008.26890. Epub 2009 Feb 25.
    Results Reference
    derived

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