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Nursing-Home Residents Given Bread Fortified With Vitamin D3

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ClinicalTrials.gov Identifier: NCT00789503
Recruitment Status : Completed
First Posted : November 13, 2008
Last Update Posted : November 13, 2008
Sponsor:
Collaborator:
Natural Ovens of Manitowoc, Manitowoc, USA
Information provided by:
University of Toronto

Brief 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.


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

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: N/A
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
Study Start Date : November 2004
Actual Primary Completion Date : December 2005
Actual Study Completion Date : December 2005


Arm Intervention/treatment
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




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

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   58 Years to 89 Years   (Adult, Older Adult)
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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr Reinhold Vieth, Mount Sinai Hospital, Toronto
ClinicalTrials.gov Identifier: NCT00789503    
Other Study ID Numbers: Bread Vitamin D
First Posted: November 13, 2008    Key Record Dates
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:
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Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamin D
Cholecalciferol
Calcium
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Calcium-Regulating Hormones and Agents
Bone Density Conservation Agents