Mozzarella Cheese Vitamin D and Bioavailability

Change in Serum 25 Hydroxyvitamin D Levels Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01919905
• Other study ID #: M2326
• Status: Completed
• Phase: N/A
• First received: March 9, 2012
• Last updated: August 6, 2013
• Start date: January 2012
• Est. completion date: April 2012

Study information

• Verified date: August 2013
• Source: University of Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Change in Serum 25 Hydroxyvitamin D Levels

Intervention

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

Locations

Country	Name	City	State
Canada	George Brown College	Toronto	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
University of Toronto	George Brown College, Ryerson University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 months	No
Secondary	Monitoring dose safety	Monitor serum calcium, phosphate, creatinine, parathyroid hormone (PTH), as well as urine calcium, phosphate, and creatinine.	2 months	No