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Nursing-Home Residents Given Bread Fortified With Vitamin D3

NCT ID: NCT00789503

Last Updated: 2008-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-11-30

Study Completion Date

2005-12-31

Brief Summary

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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

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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.

Conditions

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Vitamin D Deficiency Low Bone Density

Keywords

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dietary fortification Vitamin D3 Osteomalacia bread bone mineral density geriatrics cholecalciferol calcidiol osteoporosis dual-energy photon absorptiometry bread fortification

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Bread fortified with vitamin D3 and calcium

Group Type EXPERIMENTAL

Bread fortified with vitamin D3 and calcium

Intervention Type DIETARY_SUPPLEMENT

Bread fortified with vitamin D3 (5000 IU per bun) and calcium

Interventions

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Bread fortified with vitamin D3 and calcium

Bread fortified with vitamin D3 (5000 IU per bun) and calcium

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Healthy seniors in an institution in Romania

Exclusion Criteria

* Known hypercalcemic or hypercalciuric disease
Minimum Eligible Age

58 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Natural Ovens of Manitowoc, Manitowoc, USA

UNKNOWN

Sponsor Role collaborator

University of Toronto

OTHER

Sponsor Role lead

Responsible Party

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Mount Sinai Hospital, Toronto

References

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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.

Reference Type DERIVED
PMID: 24120120 (View on PubMed)

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.

Reference Type DERIVED
PMID: 19244376 (View on PubMed)

Other Identifiers

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Bread Vitamin D

Identifier Type: -

Identifier Source: org_study_id