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
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ 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


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

Ages Eligible for Study:   4 Years to 60 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

Additional Information:
No publications provided

Responsible Party: Lone Banke Rasmussen, National Food Institute, Technical University of Denmark
ClinicalTrials.gov Identifier: NCT01184716     History of Changes
Other Study ID Numbers: 12394
Study First Received: August 17, 2010
Last Updated: May 6, 2011
Health Authority: Denmark: Ethics Committee
Denmark: Danish Dataprotection Agency

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

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

ClinicalTrials.gov processed this record on April 17, 2014