NCT01919905

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 9, 2012

Completed
23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
1.4 years until next milestone

First Posted

Study publicly available on registry

August 9, 2013

Completed
Last Updated

August 9, 2013

Status Verified

August 1, 2013

Enrollment Period

3 months

First QC Date

March 9, 2012

Last Update Submit

August 6, 2013

Conditions

Change in Serum 25 Hydroxyvitamin D Levels

Keywords

Mozzarella cheese fortificationBioavailability of Vitamin D

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Monitoring dose safety

    2 months

Study Arms (2)

High dose

ACTIVE COMPARATOR

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

Dietary Supplement: Vitamin D

Low dose

PLACEBO COMPARATOR

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

Dietary Supplement: Vitamin D

Interventions

Vitamin DDIETARY_SUPPLEMENT

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

High doseLow dose

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy males and females between ages 18-70 years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

George Brown College

Toronto, Ontario, M5T 2T9, Canada

Location

MeSH Terms

Interventions

Vitamin D

Intervention Hierarchy (Ancestors)

SecosteroidsSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Reinhold Vieth, Phd

    Mount Sinai Hospital, Canada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Biochemist

Study Record Dates

First Submitted

March 9, 2012

First Posted

August 9, 2013

Study Start

January 1, 2012

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

August 9, 2013

Record last verified: 2013-08

Locations

CA(1)