NCT00789503

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Nov 2004

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2004

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

November 12, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 13, 2008

Completed
Last Updated

November 13, 2008

Status Verified

November 1, 2008

Enrollment Period

1.1 years

First QC Date

November 12, 2008

Last Update Submit

November 12, 2008

Conditions

Vitamin D DeficiencyLow Bone Density

Keywords

dietary fortificationVitamin D3Osteomalaciabreadbone mineral densitygeriatricscholecalciferolcalcidiolosteoporosisdual-energy photon absorptiometrybread fortification

Outcome Measures

Primary Outcomes (1)

  • Serum 25-hydroxyvitamin D response

    12 months

Secondary Outcomes (4)

  • 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

  • Change in parathyroid hormone, baseline vs final

    12 months

Study Arms (1)

Bread fortified with vitamin D3 and calcium

EXPERIMENTAL
Dietary Supplement: Bread fortified with vitamin D3 and calcium

Interventions

Bread fortified with vitamin D3 and calciumDIETARY_SUPPLEMENT

Bread fortified with vitamin D3 (5000 IU per bun) and calcium

Bread fortified with vitamin D3 and calcium

Eligibility Criteria

Age58 Years - 89 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy seniors in an institution in Romania

You may not qualify if:

  • Known hypercalcemic or hypercalciuric disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Mocanu V, Vieth R. Three-year follow-up of serum 25-hydroxyvitamin D, parathyroid hormone, and bone mineral density in nursing home residents who had received 12 months of daily bread fortification with 125 mug of vitamin D(3). Nutr J. 2013 Oct 11;12:137. doi: 10.1186/1475-2891-12-137.

    PMID: 24120120DERIVED

  • Mocanu V, Stitt PA, Costan AR, Voroniuc O, Zbranca E, Luca V, Vieth R. Long-term effects of giving nursing home residents bread fortified with 125 microg (5000 IU) vitamin D(3) per daily serving. Am J Clin Nutr. 2009 Apr;89(4):1132-7. doi: 10.3945/ajcn.2008.26890. Epub 2009 Feb 25.

    PMID: 19244376DERIVED

MeSH Terms

Conditions

Vitamin D DeficiencyBone Diseases, MetabolicOsteomalaciaOsteoporosis

Interventions

CholecalciferolCalcium

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic DiseasesBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesRicketsCalcium Metabolism Disorders

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipidsMetals, Alkaline EarthElementsInorganic ChemicalsMetalsBlood Coagulation FactorsBiological Factors

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 12, 2008

First Posted

November 13, 2008

Study Start

November 1, 2004

Primary Completion

December 1, 2005

Study Completion

December 1, 2005

Last Updated

November 13, 2008

Record last verified: 2008-11