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Completed

NCT Number: NCT01919905

Mozzarella Cheese Vitamin D and Bioavailability

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

George Brown College

Toronto, Ontario, M5T 2T9, Canada

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin D

Dietary Supplement

High dose group receive 28000 IU vitamin D once a week Low dose group receive 200 IU vitamin D once a week

Primary outcomes

  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 outcomes

  1. Monitoring dose safety

    Time frame: 2 months

    Monitor serum calcium, phosphate, creatinine, parathyroid hormone (PTH), as well as urine calcium, phosphate, and creatinine.

Sponsors and collaborators

Lead sponsor

University of Toronto

Other

Collaborators

  • George Brown College
  • Toronto Metropolitan University

Registry information

Official study title

Fortification of Mozzarella Cheese With Vitamin D3: Effect of High Temperature Cooking and Bioavailability of Vitamin D3

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Aug 9, 2013
Registry last updated
Aug 9, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.