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

This study has been completed.
Sponsor:
Information provided by:
Technical University of Denmark
ClinicalTrials.gov Identifier:
NCT01184716
First received: August 17, 2010
Last updated: May 6, 2011
Last verified: May 2011
History of Changes

August 17, 2010
May 6, 2011
September 2010
April 2011   (final data collection date for primary outcome measure)
serum 25-hydroxyvitamin D [ Time Frame: 6 months ] [ Designated as safety issue: No ]
serum 25-hydroxyvitamin D is measured at the start of the study, after 2-3 months (on adults only) and after approximately 6 months
Same as current
Complete list of historical versions of study NCT01184716 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
The Effect of Vitamin D Fortification of Bread and Milk in Danish Families
The Effect of Vitamin D Fortification of Bread and Milk in Danish Families

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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Healthy
Other: Vitamin D fortification
Bread and milk fortified with vitamin D3
  • Active Comparator: Vitamin D fortified bread and milk
    Intervention: Other: Vitamin D fortification
  • No Intervention: Non-fortified bread and milk
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
782
April 2011
April 2011   (final data collection date for primary outcome measure)

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
Both
4 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01184716
12394
No
Lone Banke Rasmussen, National Food Institute, Technical University of Denmark
Technical University of Denmark
Not Provided
Principal Investigator: Lone B Rasmussen, M.Sc., Ph.D. National Food Institute, DTU
Technical University of Denmark
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP