Nursing-Home Residents Given Bread Fortified With Vitamin D3

University of Toronto45 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Vitamin D Deficiency Low Bone Density

Interventions

Bread fortified with vitamin D3 and calciumDIETARY_SUPPLEMENT

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

Eligibility

Sex: ALLMin age: 58 YearsMax age: 89 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy seniors in an institution in Romania Exclusion Criteria: * Known hypercalcemic or hypercalciuric disease

Outcomes

Primary Outcomes

Serum 25-hydroxyvitamin D response

Time frame: 12 months

Secondary Outcomes

Effects on serum calcium

Time frame: 12 months

Effects on urine calcium

Time frame: 12 months

Change in spine and hip bone mineral density, baseline vs final

Time frame: 12 months

Change in parathyroid hormone, baseline vs final

Time frame: 12 months

Data from ClinicalTrials.gov

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