MedDataX Logo

Mozzarella Cheese Vitamin D and Bioavailability

NCT ID: NCT01919905

Last Updated: 2013-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2012-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Change in Serum 25 Hydroxyvitamin D Levels

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Mozzarella cheese fortification Bioavailability of Vitamin D

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

High dose

High dose vitamin D group receiving Mozzarella cheese/pizza with 28000 IU vitD/serving once a week

Group Type ACTIVE_COMPARATOR

Vitamin D

Intervention Type DIETARY_SUPPLEMENT

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

Low dose

Low dose vitamin D group receiving Mozzarella cheese/pizza with 200 IU vitD/serving once a week

Group Type PLACEBO_COMPARATOR

Vitamin D

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Vitamin D

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Toronto Metropolitan University

OTHER

Sponsor Role collaborator

George Brown College

OTHER

Sponsor Role collaborator

University of Toronto

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Reinhold Vieth

Clinical Biochemist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Reinhold Vieth, Phd

Role: PRINCIPAL_INVESTIGATOR

Mount Sinai Hospital, Canada

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

George Brown College

Toronto, Ontario, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Canada

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

M2326

Identifier Type: -

Identifier Source: org_study_id