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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01184716
First Posted: August 19, 2010
Last Update Posted: May 9, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Technical University of Denmark
  Purpose
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.

Condition Intervention
Healthy Other: Vitamin D fortification

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effect of Vitamin D Fortification of Bread and Milk in Danish Families

Resource links provided by NLM:


Further study details as provided by Technical University of Denmark:

Primary Outcome Measures:
  • 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


Enrollment: 782
Study Start Date: September 2010
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01184716


Locations
Denmark
Division of Nutrition, National Food Institute, Technical University of Denmark
Søborg, Denmark, 2860
Sponsors and Collaborators
Technical University of Denmark
Investigators
Principal Investigator: Lone B Rasmussen, M.Sc., Ph.D. National Food Institute, DTU
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Lone Banke Rasmussen, National Food Institute, Technical University of Denmark
ClinicalTrials.gov Identifier: NCT01184716     History of Changes
Other Study ID Numbers: 12394
First Submitted: August 17, 2010
First Posted: August 19, 2010
Last Update Posted: May 9, 2011
Last Verified: May 2011

Keywords provided by Technical University of Denmark:
Vitamin D status (serum 25-hydroxyvitamin D)

Additional relevant MeSH terms:
Vitamins
Vitamin D
Ergocalciferols
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents