The Focus is to Assess 25-hydroxyvitamin D Levels and Well-beingNCT01555424
Vitamin D Fortified Cheese and Well-being in the Institutionalized Elderly
A study testing High dose and Reference dose in people with The Focus is to Assess 25-hydroxyvitamin D Levels and Well-being, run by University of Toronto at 1 site in Canada.
Trial summary
The investigators hypotheses is that the consumption of the investigators vitamin D fortified cheese will result in an increase in serum 25-hydroxy vitamin D levels in older institutionalized adults. Read more about this study
- Who is it for?
- Ages 70 years and olderHealthy volunteers can take part
- Conditions the study is for
- The Focus is to Assess 25-hydroxyvitamin D Levels and Well-being
- What is being tested?
- High dose and Reference dose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2012to Apr 2012
- Phase
- Interventional
- 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 70 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Lactose intolerance
- Generally "Healthy", unless disease status deemed clinically significant and unable to participate by the attending physician.
Who cannot join
- Hypercalcemia/hypercalciuria
- Interfering medications
- Significant sun exposure in the months before and during the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bioavailability of Casein-bound Vitamin D From Fortified Cheese and Its Effects on the Well-being of the Institutionalized Elderly
The investigators hypotheses is that the consumption of the investigators vitamin D fortified cheese will result in an increase in serum 25-hydroxy vitamin D levels in older institutionalized adults. Also, the consumption of the cheese with the higher amount of vitamin D will result in an improvement in wellbeing scores.
Read the detailed description
The institute of medicine increased the dietary reference intakes of vitamin D for all of the age groups. The Recommended Daily Allowance (RDA) is now 800 IU for older adults over the age of 70, and the Tolerable Upper Level (UL) is 4000 IU daily. Canadians are known to have an inadequate vitamin D status, and older institutionalized adults are particularly susceptible to this. One strategy to correct this is to fortify more kinds of foods with vitamin D. We have already demonstrated that we can get vitamin D into cheddar cheese and it is as biologically available as vitamin D in the liquid supplement.
This new project aims to optimize the fortification process and deliver all of the vitamin D into cheddar cheese, and to measure its bioavailability and related changes in well-being during winter. We will assess the well being of the older institutionalized adults by administering the SF-36v2 health survey.
- Being tested
- High dose, Reference dose
- Keywords
- 25-hydroxyvitamin D, Institutionalized seniors, SF-36 survey, Winter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High doseDietary supplement
This arm of the study receives a higher dose of the vitamin D fortified cheese (28,000IU/ 50g of cheddar cheese eaten once a week).
Reference doseDietary supplement
This arm of the study receives a lower dose of the vitamin D fortified cheese (200IU/ 50g of cheddar cheese eaten once a week).
| Study group | Role | What they receive |
|---|---|---|
| High dose | Active comparator | Not described Receives: Dietary Supplement: High dose |
| Reference dose | Active comparator | Not described Receives: Dietary Supplement: Reference dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
The bioavailability of vitamin D from cheddar cheese fortified with vitamin D, in older institutionalized adults
We are adminstering 2 doses of vitamin D fortified cheese. One cheese contains a higher 28,000 IU/week dose that we expect to see health benefits with. The other cheese contains a 200IU/week dose that is similar to the current milk fortification practice in Canada (100IU per serving).
Measured: 2 months
Secondary outcomes (1)
A change in wellbeing scores using an SF-36 survey in the older institutionalized adults
We have previously shown that a group of adults showed an improvement in their wellbeing scores after the consumption of 28,000 IU/week of vitamin D during the winter months. Therefore, we will assess whether well-being changes in older institutionalized adults after the consumption of the vitamin D fortifed cheese, by using an SF-36 well-being survey.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2012 (estimated)
- Study startFeb 2012
- Primary completionApr 2012 (estimated)
- Study completionApr 2012 (estimated)
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 The Focus is to Assess 25-hydroxyvitamin D Levels and Well-beingStudies 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 N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reinhold Vieth, University of Toronto
- Investigators
- Reinhold Vieth, PhD,FCACB, Principal investigator, U of Toronto, Mount Sinai HospitalPierre Geoffroy, MD, Principal investigator, Aurora Retirement Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01555424
- Sponsor's protocol ID
- M2327
- Status last verified
- Mar 2012
- First submitted
- 13 Mar 2012
- Last updated
- 15 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Wagner D, Sidhom G, Whiting SJ, Rousseau D, Vieth R. The bioavailability of vitamin D from fortified cheeses and supplements is equivalent in adults. J Nutr. 2008 Jul;138(7):1365-71. doi: 10.1093/jn/138.7.1365.
PubMed 18567762Vieth R, Kimball S, Hu A, Walfish PG. Randomized comparison of the effects of the vitamin D3 adequate intake versus 100 mcg (4000 IU) per day on biochemical responses and the wellbeing of patients. Nutr J. 2004 Jul 19;3:8. doi: 10.1186/1475-2891-3-8.
PubMed 15260882
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioavailability of Casein-bound Vitamin D From Fortified Cheese and Its Effects on the Well-being of the Institutionalized Elderly
- ClinicalTrials.gov ID
- NCT01555424
- Acronym / sponsor ID
- M2327
- Keywords
- 25-hydroxyvitamin D, Institutionalized seniors, SF-36 survey, Winter
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Apr 2012 (estimated)
- Study completion
- Apr 2012 (estimated)
- First posted
- 15 Mar 2012 (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.
The investigators hypotheses is that the consumption of the investigators vitamin D fortified cheese will result in an increase in serum 25-hydroxy vitamin D levels in older institutionalized adults. Also, the consumption of the cheese with the higher amount of vitamin D will result in an improvement in wellbeing scores.
Detailed description
The institute of medicine increased the dietary reference intakes of vitamin D for all of the age groups. The Recommended Daily Allowance (RDA) is now 800 IU for older adults over the age of 70, and the Tolerable Upper Level (UL) is 4000 IU daily. Canadians are known to have an inadequate vitamin D status, and older institutionalized adults are particularly susceptible to this. One strategy to correct this is to fortify more kinds of foods with vitamin D. We have already demonstrated that we can get vitamin D into cheddar cheese and it is as biologically available as vitamin D in the liquid supplement.
This new project aims to optimize the fortification process and deliver all of the vitamin D into cheddar cheese, and to measure its bioavailability and related changes in well-being during winter. We will assess the well being of the older institutionalized adults by administering the SF-36v2 health survey.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High dose | Active comparator | Dietary Supplement: High dose |
| Reference dose | Active comparator | Dietary Supplement: Reference dose |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Lactose intolerance
- Generally "Healthy", unless disease status deemed clinically significant and unable to participate by the attending physician.
Key exclusion criteria (3 listed)
- Hypercalcemia/hypercalciuria
- Interfering medications
- Significant sun exposure in the months before and during the study
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 |
|---|---|---|
| High doseThis arm of the study receives a higher dose of the vitamin D fortified cheese (28,000IU/ 50g of cheddar cheese eaten once a week). | Dietary supplement | High dose |
| Reference doseThis arm of the study receives a lower dose of the vitamin D fortified cheese (200IU/ 50g of cheddar cheese eaten once a week). | Dietary supplement | Reference dose |
Primary outcome
The bioavailability of vitamin D from cheddar cheese fortified with vitamin D, in older institutionalized adults
Time frame: 2 months
We are adminstering 2 doses of vitamin D fortified cheese. One cheese contains a higher 28,000 IU/week dose that we expect to see health benefits with. The other cheese contains a 200IU/week dose that is similar to the current milk fortification practice in Canada (100IU per serving).
1 secondary outcome
A change in wellbeing scores using an SF-36 survey in the older institutionalized adults
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2012.
- Background: PubMed 18567762Wagner D, Sidhom G, Whiting SJ, Rousseau D, Vieth R. The bioavailability of vitamin D from fortified cheeses and supplements is equivalent in adults. J Nutr. 2008 Jul;138(7):1365-71. doi: 10.1093/jn/138.7.1365.
- Background: PubMed 15260882Vieth R, Kimball S, Hu A, Walfish PG. Randomized comparison of the effects of the vitamin D3 adequate intake versus 100 mcg (4000 IU) per day on biochemical responses and the wellbeing of patients. Nutr J. 2004 Jul 19;3:8. doi: 10.1186/1475-2891-3-8.
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.
Reinhold Vieth, PhD,FCACB principal investigator
U of Toronto, Mount Sinai Hospital
Pierre Geoffroy, MD principal investigator
Aurora Retirement Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High dose and Reference dose in people with The Focus is to Assess 25-hydroxyvitamin D Levels and Well-being, run by University of Toronto at 1 site in Canada.
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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 15 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
Results are not available in the source record.
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?
The bioavailability of vitamin D from cheddar cheese fortified with vitamin D, in older institutionalized adults (time frame: 2 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 NCT01555424, 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 15 Mar 2012.