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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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on November 27, 2014