Mozzarella Cheese Vitamin D and Bioavailability

Study Overview
=================
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).

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

Conditions
-----------------
Change in Serum 25 Hydroxyvitamin D Levels

Intervention / Treatment
-----------------
* Dietary Supplement: Vitamin D


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: High dose<br>High dose vitamin D group receiving Mozzarella cheese/pizza with 28000 IU vitD/serving once a week | Dietary Supplement: Vitamin D<br>* High dose group receive 28000 IU vitamin D once a week Low dose group receive 200 IU vitamin D once a week<br>|
| Placebo Comparator: Low dose<br>Low dose vitamin D group receiving Mozzarella cheese/pizza with 200 IU vitD/serving once a week | Dietary Supplement: Vitamin D<br>* High dose group receive 28000 IU vitamin D once a week Low dose group receive 200 IU vitamin D once a week<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mozzarella cheese fortification, Bioavailability of Vitamin D