The Effect of Vitamin D Fortification of Bread and Milk in Danish Families (VitMaD)

May 6, 2011 updated by: Technical University of Denmark
Approximately 200 families corresponding to 800 persons are included in the study. The study investigate the efficacy of vitamin D fortification of bread and milk on vitamin D status in serum. Participants receive milk and bread twice a week. Half of the participants receive vitamin D fortified products and the other half similar non-fortified products. The study starts in September and runs for 6 months during winter, the period where it is not possible to produce vitamin D in the skin through sunlight exposure. The hypothesis is that the usual fall in vitamin D status can be prevented by vitamin D fortified food.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

782

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Søborg, Denmark, 2860
        • Division of Nutrition, National Food Institute, Technical University of Denmark

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 60 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Family with at least one child between the age 4 to 18 years and at least one adult less than 60 years of age
  • Permanent address in a specific geographical region.

Exclusion Criteria:

  • Use of medication (including dietary supplements with high levels of vitamin D)
  • Diseases which influence vitamin D metabolism
  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Vitamin D fortified bread and milk
Other: Vitamin D fortification
Bread and milk fortified with vitamin D3
No Intervention: Non-fortified bread and milk

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
serum 25-hydroxyvitamin D
Time Frame: 6 months
serum 25-hydroxyvitamin D is measured at the start of the study, after 2-3 months (on adults only) and after approximately 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Technical University of Denmark

Investigators

  • Principal Investigator: Lone B Rasmussen, M.Sc., Ph.D., National Food Institute, DTU

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Actual)

April 1, 2011

Study Completion (Actual)

April 1, 2011

Study Registration Dates

First Submitted

August 17, 2010

First Submitted That Met QC Criteria

August 18, 2010

First Posted (Estimate)

August 19, 2010

Study Record Updates

Last Update Posted (Estimate)

May 9, 2011

Last Update Submitted That Met QC Criteria

May 6, 2011

Last Verified

May 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12394

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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