Nursing-Home Residents Given Bread Fortified With Vitamin D3

University of Toronto

Status and phase: Completed; Phase 2; Phase 1

Conditions: Low Bone Density; Vitamin D Deficiency

Treatments: Dietary Supplement: Bread fortified with vitamin D3 and calcium

Study type: Interventional

Funder types: Other

Identifiers

NCT00789503

Bread Vitamin D

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 patients

Sex: All

Ages: 58 to 89 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy seniors in an institution in Romania

Exclusion criteria

• Known hypercalcemic or hypercalciuric disease

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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45 participants in 1 patient group

Bread fortified with vitamin D3 and calcium

Experimental group

Treatment:

Dietary Supplement: Bread fortified with vitamin D3 and calcium