Text Size

Nursing-Home Residents Given Bread Fortified With Vitamin D3

This study has been completed.
Sponsor:
Collaborator:
Natural Ovens of Manitowoc, Manitowoc, USA
Information provided by:
University of Toronto
ClinicalTrials.gov Identifier:
NCT00789503
First received: November 12, 2008
Last updated: NA
Last verified: November 2008
History: No changes posted
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

U.S. FDA Resources

Further study details as provided by University of Toronto:

Primary Outcome Measures:
  • Serum 25-hydroxyvitamin D response [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Effects on serum calcium [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Effects on urine calcium [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Change in spine and hip bone mineral density, baseline vs final [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Change in parathyroid hormone, baseline vs final [ Time Frame: 12 months ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   58 Years to 89 Years
Genders Eligible for Study:   Both
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

No publications provided by University of Toronto

Additional 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
Study First Received: November 12, 2008
Last Updated: November 12, 2008
Health Authority: ROMANIA: University of Medicin and Pharmacy Iasi "Gr. T. Popa", 16, Universitatii, 700115 Iasi

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
Calcium, Dietary
Cholecalciferol
Vitamin D
 Ergocalciferols
Vitamins
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on May 19, 2013