Change in Serum 25 Hydroxyvitamin D LevelsNCT01919905
Mozzarella Cheese Vitamin D and Bioavailability
A study testing Vitamin D in people with Change in Serum 25 Hydroxyvitamin D Levels, run by University of Toronto at 1 site in Canada.
Trial summary
The purpose of this study is to evaluate the effect of heat on the bioavailability of vitamin D in industrially fortified mozzarella cheese baked with pizza. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Change in Serum 25 Hydroxyvitamin D Levels
- What is being tested?
- Vitamin D
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- Jan 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy males and females between ages 18-70 years
Who cannot join
- Use of vitamin D supplements in excess of 1000 IU/day
- A history of any medical disorder that might effect vitamin D or mineral metabolism
- Use of medications that could interfere with vitamin D metabolism
- Potential for sun exposure ( i.e travel to a sunny destination of use of tanning beds) within the month prior to or during the study
- History of hypercalcemia
- Unwillingness to return for follow up
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fortification of Mozzarella Cheese With Vitamin D3: Effect of High Temperature Cooking and Bioavailability of Vitamin D3
The purpose of this study is to evaluate the effect of heat on the bioavailability of vitamin D in industrially fortified mozzarella cheese baked with pizza.
Read the detailed description
With a growing body of evidence, the Institute of Medicine (IOM) conducted a thorough review of all available evidence to publish a report on Dietary Reference Intakes (DRIs) for calcium and vitamin D. In the absence of adequate sun exposure, acquiring the new RDA of 600-800 IU/d for vitamin D through diet alone is difficult. There is a need to increase dietary sources of vitamin D for Canadians.
In a double blind, randomized trial, our objective was to assess the effect of high temperature pizza baking on the bioavailability of vitamin D3 fortified Mozzarella cheese. We tested the following hypotheses, set a priori: 1) vitamin D3 is bioavailable from pizza baked with fortified Mozzarella cheese and heat does not significantly break down vitamin D3; and 2) the change in serum 25(OH)D (from baseline to 10 wk) will be significantly greater in the high-dose vitamin D treated group (28000 IU/wk) compared to the low dose vitamin D-treated group (200 IU/wk).
- Being tested
- Vitamin D
- Keywords
- Mozzarella cheese fortification, Bioavailability of Vitamin D
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DDietary supplement
High dose group receive 28000 IU vitamin D once a week Low dose group receive 200 IU vitamin D once a week
| Study group | Role | What they receive |
|---|---|---|
| High dose | Active comparator | High dose vitamin D group receiving Mozzarella cheese/pizza with 28000 IU vitD/serving once a week Receives: Dietary Supplement: Vitamin D |
| Low dose | Placebo comparator | Low dose vitamin D group receiving Mozzarella cheese/pizza with 200 IU vitD/serving once a week Receives: Dietary Supplement: Vitamin D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioavailability of vitamin D fortified Mozzarella cheese after pizza baking
Blood 25(OH)D levels will be measured at baseline and at the end of the study between low dose vs. high dose vitamin D group.
Measured: 2 months
Secondary outcomes (1)
Monitoring dose safety
Monitor serum calcium, phosphate, creatinine, parathyroid hormone (PTH), as well as urine calcium, phosphate, and creatinine.
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 posted9 Aug 2013 (estimated)
- Study startJan 2012
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Change in Serum 25 Hydroxyvitamin D LevelsStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Toronto Metropolitan University, George Brown College
- Responsible party
- Principal investigator, Reinhold Vieth, University of Toronto
- Investigators
- Reinhold Vieth, Phd, Principal investigator, Mount Sinai Hospital, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01919905
- Sponsor's protocol ID
- M2326
- Status last verified
- Aug 2013
- First submitted
- 9 Mar 2012
- Last updated
- 9 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fortification of Mozzarella Cheese With Vitamin D3: Effect of High Temperature Cooking and Bioavailability of Vitamin D3
- ClinicalTrials.gov ID
- NCT01919905
- Acronym / sponsor ID
- M2326
- Keywords
- Mozzarella cheese fortification, Bioavailability of Vitamin D
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Collaborators
- Toronto Metropolitan University, George Brown College
- Study start
- Jan 2012
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 9 Aug 2013 (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 purpose of this study is to evaluate the effect of heat on the bioavailability of vitamin D in industrially fortified mozzarella cheese baked with pizza.
Detailed description
With a growing body of evidence, the Institute of Medicine (IOM) conducted a thorough review of all available evidence to publish a report on Dietary Reference Intakes (DRIs) for calcium and vitamin D. In the absence of adequate sun exposure, acquiring the new RDA of 600-800 IU/d for vitamin D through diet alone is difficult. There is a need to increase dietary sources of vitamin D for Canadians.
In a double blind, randomized trial, our objective was to assess the effect of high temperature pizza baking on the bioavailability of vitamin D3 fortified Mozzarella cheese. We tested the following hypotheses, set a priori: 1) vitamin D3 is bioavailable from pizza baked with fortified Mozzarella cheese and heat does not significantly break down vitamin D3; and 2) the change in serum 25(OH)D (from baseline to 10 wk) will be significantly greater in the high-dose vitamin D treated group (28000 IU/wk) compared to the low dose vitamin D-treated group (200 IU/wk).
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High dose | Active comparator | Dietary Supplement: Vitamin DHigh dose vitamin D group receiving Mozzarella cheese/pizza with 28000 IU vitD/serving once a week |
| Low dose | Placebo comparator | Dietary Supplement: Vitamin DLow dose vitamin D group receiving Mozzarella cheese/pizza with 200 IU vitD/serving once a week |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy males and females between ages 18-70 years
Key exclusion criteria (6 listed)
- Use of vitamin D supplements in excess of 1000 IU/day
- A history of any medical disorder that might effect vitamin D or mineral metabolism
- Use of medications that could interfere with vitamin D metabolism
- Potential for sun exposure ( i.e travel to a sunny destination of use of tanning beds) within the month prior to or during the study
- History of hypercalcemia
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 |
|---|---|---|
| Vitamin DHigh dose group receive 28000 IU vitamin D once a week Low dose group receive 200 IU vitamin D once a week | Dietary supplement | High dose, Low dose |
Primary outcome
Bioavailability of vitamin D fortified Mozzarella cheese after pizza baking
Time frame: 2 months
Blood 25(OH)D levels will be measured at baseline and at the end of the study between low dose vs. high dose vitamin D group.
1 secondary outcome
Monitoring dose safety
Time frame: 2 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 9 Aug 2013.
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 principal investigator
Mount Sinai Hospital, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D in people with Change in Serum 25 Hydroxyvitamin D Levels, 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 1 inclusion and 6 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 9 Aug 2013. 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. Some participants in this study may receive a placebo. 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?
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?
Bioavailability of vitamin D fortified Mozzarella cheese after pizza baking (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Aug 2013.