Mozzarella Cheese Vitamin D and Bioavailability

August 6, 2013 updated by: Reinhold Vieth, University of Toronto

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5T 2T9
        • George Brown College

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Monitoring dose safety
Time Frame: 2 months
Monitor serum calcium, phosphate, creatinine, parathyroid hormone (PTH), as well as urine calcium, phosphate, and creatinine.
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Toronto

Collaborators

Ryerson University
George Brown College

Investigators

  • Principal Investigator: Reinhold Vieth, Phd, Mount Sinai Hospital, Canada

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

April 1, 2012

Study Completion (Actual)

April 1, 2012

Study Registration Dates

First Submitted

March 9, 2012

First Submitted That Met QC Criteria

August 6, 2013

First Posted (Estimate)

August 9, 2013

Study Record Updates

Last Update Posted (Estimate)

August 9, 2013

Last Update Submitted That Met QC Criteria

August 6, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M2326

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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