Mozzarella Cheese Vitamin D and Bioavailability

Not Applicable

Completed

• Conditions: Change in Serum 25 Hydroxyvitamin D Levels
• Interventions: Dietary Supplement: Vitamin D

• Registration Number: NCT01919905
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-03-09
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Status Verified: 2013-08
• Study First Submitted QC: 2013-08-06
• Last Update Submitted: 2013-08-06
• Study First Posted: 2013-08-09
• Last Update Posted: 2013-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Healthy males and females between ages 18-70 years

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High dose	Vitamin D	High dose vitamin D group receiving Mozzarella cheese/pizza with 28000 IU vitD/serving once a week
Low dose	Vitamin D	Low dose vitamin D group receiving Mozzarella cheese/pizza with 200 IU vitD/serving once a week

Primary Outcome Measures

Name	Time	Method
Bioavailability of vitamin D fortified Mozzarella cheese after pizza baking	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

Name	Time	Method
Monitoring dose safety	2 months	Monitor serum calcium, phosphate, creatinine, parathyroid hormone (PTH), as well as urine calcium, phosphate, and creatinine.

Trial Locations

Locations (1)

George Brown College; 🇨🇦 Toronto, Ontario, Canada