Low Bone Density, Vitamin D Deficiency
Conditions
Keywords
dietary fortification, Vitamin D3, Osteomalacia, bread, bone mineral density, geriatrics, cholecalciferol, calcidiol, osteoporosis, dual-energy photon absorptiometry, bread fortification
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.
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.
Interventions
DIETARY_SUPPLEMENTBread fortified with vitamin D3 and calcium
Bread fortified with vitamin D3 (5000 IU per bun) and calcium
Sponsors
Natural Ovens of Manitowoc, Manitowoc, USA
University of Toronto
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
58 Years to 89 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy seniors in an institution in Romania
Exclusion criteria
* Known hypercalcemic or hypercalciuric disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum 25-hydroxyvitamin D response | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Change in parathyroid hormone, baseline vs final | 12 months |
| Effects on serum calcium | 12 months |
| Effects on urine calcium | 12 months |
| Change in spine and hip bone mineral density, baseline vs final | 12 months |
Outcome results
None listed