Nursing-Home Residents Given Bread Fortified With Vitamin D3 - Full Text View

Sponsors and Collaborators:	University of Toronto Natural Ovens of Manitowoc, Manitowoc, USA
Information provided by:	University of Toronto
ClinicalTrials.gov Identifier:	NCT00789503

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 I Phase II

MedlinePlus related topics: Calcium Minerals Nursing Homes

Drug Information available for: Calcium gluconate Vitamin D Ergocalciferol Cholecalciferol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Long-Term Effects of Giving Nursing-Home Residents Bread Fortified With 125 Micrograms (5000 IU) Vitamin D3 Per Daily Serving

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
Bread fortified with vitamin D3 and calcium: Experimental	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

Responsible Party:	Mount Sinai Hospital, Toronto ( Dr Reinhold Vieth )
Study ID Numbers:	Bread Vitamin D
Study First Received:	November 12, 2008
Last Updated:	November 12, 2008
ClinicalTrials.gov Identifier:	NCT00789503
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

Study placed in the following topic categories:

Vitamin D Deficiency
Calcium, Dietary
Cholecalciferol
Vitamin D
Malnutrition
Avitaminosis

Ergocalciferols
Nutrition Disorders
Osteoporosis
Osteomalacia
Deficiency Diseases

Additional relevant MeSH terms:

Growth Substances
Vitamins
Physiological Effects of Drugs

Bone Density Conservation Agents
Micronutrients
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009