Nursing-Home Residents Given Bread Fortified With Vitamin D3

Vitamin D Deficiency Clinical Trial

Official title:

Long-Term Effects of Giving Nursing-Home Residents Bread Fortified With 125 Micrograms (5000 IU) Vitamin D3 Per Daily Serving

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00789503
• Other study ID #: Bread Vitamin D
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: November 12, 2008
• Last updated: November 12, 2008
• Start date: November 2004
• Est. completion date: December 2005

Study information

• Verified date: November 2008
• Source: University of Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: ROMANIA: University of Medicin and Pharmacy Iasi "Gr. T. Popa", 16, Universitatii, 700115 Iasi
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: December 2005
• Est. primary completion date: December 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 58 Years to 89 Years

Eligibility

Inclusion Criteria:

• Healthy seniors in an institution in Romania

Exclusion Criteria:

• Known hypercalcemic or hypercalciuric disease

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Low Bone Density
• Vitamin D Deficiency

Intervention

Dietary Supplement:
• Bread fortified with vitamin D3 and calcium
Bread fortified with vitamin D3 (5000 IU per bun) and calcium

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Toronto	Natural Ovens of Manitowoc, Manitowoc, USA

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum 25-hydroxyvitamin D response		12 months	Yes
Secondary	Effects on serum calcium		12 months	Yes
Secondary	Effects on urine calcium		12 months	Yes
Secondary	Change in spine and hip bone mineral density, baseline vs final		12 months	No
Secondary	Change in parathyroid hormone, baseline vs final		12 months	No