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OpenTrials
Completed

NCT Number: NCT00789503

Nursing-Home Residents Given Bread Fortified With Vitamin D3

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.

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Key information

Conditions

Vitamin D Deficiency Avitaminosis Bone Diseases Bone Diseases, Metabolic Calcium Metabolism Disorders Deficiency Diseases Low Bone Density Malnutrition Metabolic Diseases Musculoskeletal Diseases Nutrition Disorders Nutritional and Metabolic Diseases Osteomalacia Osteoporosis Rickets

Age range

58 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy seniors in an institution in Romania

Exclusion criteria

  • Known hypercalcemic or hypercalciuric disease

Treatment and study plan

Bread fortified with vitamin D3 and calcium

Dietary Supplement

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

Primary outcomes

  1. Serum 25-hydroxyvitamin D response

    Time frame: 12 months

Secondary outcomes

  1. Effects on serum calcium

    Time frame: 12 months

  2. Effects on urine calcium

    Time frame: 12 months

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

    Time frame: 12 months

  4. Change in parathyroid hormone, baseline vs final

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

University of Toronto

Other

Collaborators

  • Natural Ovens of Manitowoc, Manitowoc, USA

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Nov 13, 2008
Registry last updated
Nov 13, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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