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Mozzarella Cheese Vitamin D and Bioavailability

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ClinicalTrials.gov Identifier: NCT01919905
Recruitment Status : Completed
First Posted : August 9, 2013
Last Update Posted : August 9, 2013
Sponsor:
Collaborators:
Ryerson University
George Brown College
Information provided by (Responsible Party):
Reinhold Vieth, University of Toronto

Brief 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.

Condition or disease Intervention/treatment Phase
Change in Serum 25 Hydroxyvitamin D Levels Dietary Supplement: Vitamin D Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Official Title: Fortification of Mozzarella Cheese With Vitamin D3: Effect of High Temperature Cooking and Bioavailability of Vitamin D3
Study Start Date : January 2012
Actual Primary Completion Date : April 2012
Actual Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D
Drug Information available for: Vitamin D

Arm Intervention/treatment
Active Comparator: High dose
High dose vitamin D group receiving Mozzarella cheese/pizza with 28000 IU vitD/serving once a week
Dietary Supplement: Vitamin D
High dose group receive 28000 IU vitamin D once a week Low dose group receive 200 IU vitamin D once a week

Placebo Comparator: Low dose
Low dose vitamin D group receiving Mozzarella cheese/pizza with 200 IU vitD/serving once a week
Dietary Supplement: Vitamin D
High dose group receive 28000 IU vitamin D once a week Low dose group receive 200 IU vitamin D once a week




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Monitoring dose safety [ Time Frame: 2 months ]
    Monitor serum calcium, phosphate, creatinine, parathyroid hormone (PTH), as well as urine calcium, phosphate, and creatinine.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy males and females between ages 18-70 years

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01919905


Locations
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Canada, Ontario
George Brown College
Toronto, Ontario, Canada, M5T 2T9
Sponsors and Collaborators
University of Toronto
Ryerson University
George Brown College
Investigators
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Principal Investigator: Reinhold Vieth, Phd Mount Sinai Hospital, Canada
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Responsible Party: Reinhold Vieth, Clinical Biochemist, University of Toronto
ClinicalTrials.gov Identifier: NCT01919905    
Other Study ID Numbers: M2326
First Posted: August 9, 2013    Key Record Dates
Last Update Posted: August 9, 2013
Last Verified: August 2013
Keywords provided by Reinhold Vieth, University of Toronto:
Mozzarella cheese fortification
Bioavailability of Vitamin D
Additional relevant MeSH terms:
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Vitamin D
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents