Nursing-Home Residents Given Bread Fortified With Vitamin D3

November 12, 2008 updated by: University of Toronto

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

45

Phase

  • Phase 2
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

58 years to 89 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy seniors in an institution in Romania

Exclusion Criteria:

  • Known hypercalcemic or hypercalciuric disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Serum 25-hydroxyvitamin D response
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Effects on serum calcium
Time Frame: 12 months
12 months
Effects on urine calcium
Time Frame: 12 months
12 months
Change in spine and hip bone mineral density, baseline vs final
Time Frame: 12 months
12 months
Change in parathyroid hormone, baseline vs final
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Toronto

Collaborators

Natural Ovens of Manitowoc, Manitowoc, USA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2004

Primary Completion (ACTUAL)

December 1, 2005

Study Completion (ACTUAL)

December 1, 2005

Study Registration Dates

First Submitted

November 12, 2008

First Submitted That Met QC Criteria

November 12, 2008

First Posted (ESTIMATE)

November 13, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

November 13, 2008

Last Update Submitted That Met QC Criteria

November 12, 2008

Last Verified

November 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Bread Vitamin D

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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