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Nursing-Home Residents Given Bread Fortified With Vitamin D3

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00789503
First Posted: November 13, 2008
Last Update Posted: November 13, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Natural Ovens of Manitowoc, Manitowoc, USA
Information provided by:
University of Toronto
  Purpose

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.


Condition Intervention Phase
Vitamin D Deficiency Low Bone Density Dietary Supplement: Bread fortified with vitamin D3 and calcium Phase 1 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Long-Term Effects of Giving Nursing-Home Residents Bread Fortified With 125 Micrograms (5000 IU) Vitamin D3 Per Daily Serving

Resource links provided by NLM:


Further study details as provided by University of Toronto:

Primary Outcome Measures:
  • Serum 25-hydroxyvitamin D response [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 45
Study Start Date: November 2004
Study Completion Date: December 2005
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bread fortified with vitamin D3 and calcium Dietary Supplement: Bread fortified with vitamin D3 and calcium
Bread fortified with vitamin D3 (5000 IU per bun) and calcium

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   58 Years to 89 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy seniors in an institution in Romania

Exclusion Criteria:

  • Known hypercalcemic or hypercalciuric disease
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr Reinhold Vieth, Mount Sinai Hospital, Toronto
ClinicalTrials.gov Identifier: NCT00789503     History of Changes
Other Study ID Numbers: Bread Vitamin D
First Submitted: November 12, 2008
First Posted: November 13, 2008
Last Update Posted: November 13, 2008
Last Verified: November 2008

Keywords provided by University of Toronto:
dietary fortification
Vitamin D3
Osteomalacia
bread
bone mineral density
geriatrics
cholecalciferol
calcidiol
osteoporosis
dual-energy photon absorptiometry
bread fortification

Additional relevant MeSH terms:
Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Calcium, Dietary
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents