Nursing-Home Residents Given Bread Fortified With Vitamin D3

Phase 1

Completed

• Conditions: Vitamin D Deficiency; Low Bone Density
• Interventions: Dietary Supplement: Bread fortified with vitamin D3 and calcium

• Registration Number: NCT00789503
• Lead Sponsor: University of Toronto

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.

Study Timeline

• Study Start: 2004-11
• Primary Completion: 2005-12
• Study Completion: 2005-12
• Status Verified: 2008-11
• Study First Submitted: 2008-11-12
• Study First Submitted QC: 2008-11-12
• Last Update Submitted: 2008-11-12
• Study First Posted: 2008-11-13
• Last Update Posted: 2008-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• Healthy seniors in an institution in Romania

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Exclusion Criteria

• Known hypercalcemic or hypercalciuric disease

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bread fortified with vitamin D3 and calcium	Bread fortified with vitamin D3 and calcium	-

Primary Outcome Measures

Name	Time	Method
Serum 25-hydroxyvitamin D response	12 months

Secondary Outcome Measures

Name	Time	Method
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