Vitamin D DeficiencyPhase 1/2NCT00789503
Nursing-Home Residents Given Bread Fortified With Vitamin D3
A Phase 1/2 study testing Bread fortified with vitamin D3 and calcium in people with Vitamin D Deficiency and Low Bone Density, run by University of Toronto.
Trial 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. Read more about this study
- Who is it for?
- Ages 58 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency, Low Bone Density
- What is being tested?
- Bread fortified with vitamin D3 and calcium
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- Nov 2004to Dec 2005
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 58 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy seniors in an institution in Romania
Who cannot join
- Known hypercalcemic or hypercalciuric disease
About this study
Official title: Long-Term Effects of Giving Nursing-Home Residents Bread Fortified With 125 Micrograms (5000 IU) Vitamin D3 Per Daily Serving
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.
Read the 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.
- Conditions
- Vitamin D Deficiency, Low Bone Density
- Being tested
- Bread fortified with vitamin D3 and calcium
- Keywords
- dietary fortification, Vitamin D3, Osteomalacia, bread, bone mineral density, geriatrics, cholecalciferol, calcidiol, osteoporosis, dual-energy photon absorptiometry, bread fortification
- Medical subject headings
- Vitamin D Deficiency, Bone Diseases, Metabolic, Osteomalacia, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bread fortified with vitamin D3 and calciumDietary supplement
Bread fortified with vitamin D3 (5000 IU per bun) and calcium
| Study group | Role | What they receive |
|---|---|---|
| Bread fortified with vitamin D3 and calcium | Experimental | Not described Receives: Dietary Supplement: Bread fortified with vitamin D3 and calcium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum 25-hydroxyvitamin D response
Measured: 12 months
Secondary outcomes (4)
Effects on serum calcium
Measured: 12 months
Effects on urine calcium
Measured: 12 months
Change in spine and hip bone mineral density, baseline vs final
Measured: 12 months
Change in parathyroid hormone, baseline vs final
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2008 (estimated)
- Study startNov 2004
- Primary completionDec 2005
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Vitamin D DeficiencyStudies of the same condition, open and under way.
- More trials run by University of TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Natural Ovens of Manitowoc, Manitowoc, USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00789503
- Sponsor's protocol ID
- Bread Vitamin D
- Status last verified
- Nov 2008
- First submitted
- 12 Nov 2008
- Last updated
- 13 Nov 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24120120Mocanu 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.
PubMed 19244376
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term Effects of Giving Nursing-Home Residents Bread Fortified With 125 Micrograms (5000 IU) Vitamin D3 Per Daily Serving
- ClinicalTrials.gov ID
- NCT00789503
- Acronym / sponsor ID
- Bread Vitamin D
- Conditions
- Vitamin D Deficiency, Low Bone Density
- Keywords
- dietary fortification, Vitamin D3, Osteomalacia, bread, bone mineral density, geriatrics, cholecalciferol, calcidiol
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Collaborators
- Natural Ovens of Manitowoc, Manitowoc, USA
- Study start
- Nov 2004
- Primary completion
- Dec 2005 (actual)
- Study completion
- Dec 2005 (actual)
- First posted
- 13 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bread fortified with vitamin D3 and calcium | Experimental | Dietary Supplement: Bread fortified with vitamin D3 and calcium |
Who may qualify
- Ages
- 58 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy seniors in an institution in Romania
Key exclusion criteria (1 listed)
- Known hypercalcemic or hypercalciuric disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bread fortified with vitamin D3 and calciumBread fortified with vitamin D3 (5000 IU per bun) and calcium | Dietary supplement | Bread fortified with vitamin D3 and calcium |
Primary outcome
Serum 25-hydroxyvitamin D response
Time frame: 12 months
4 secondary outcomes
Effects on serum calcium
Time frame: 12 months
Effects on urine calcium
Time frame: 12 months
Change in spine and hip bone mineral density, baseline vs final
Time frame: 12 months
Change in parathyroid hormone, baseline vs final
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2008.
- Derived from this study: PubMed 24120120Mocanu 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.
- Derived from this study: PubMed 19244376Mocanu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Bread fortified with vitamin D3 and calcium in people with Vitamin D Deficiency and Low Bone Density, run by University of Toronto.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2008. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum 25-hydroxyvitamin D response (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00789503, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2008.