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

Healthy Clinical Trial

— VitMaD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01184716
• Other study ID #: 12394
• Status: Completed
• Phase: N/A
• First received: August 17, 2010
• Last updated: May 6, 2011
• Start date: September 2010
• Est. completion date: April 2011

Study information

• Verified date: May 2011
• Source: Technical University of Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics CommitteeDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 782
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 4 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• Vitamin D fortification
Bread and milk fortified with vitamin D3

Locations

Country	Name	City	State
Denmark	Division of Nutrition, National Food Institute, Technical University of Denmark	Søborg

Sponsors (1)

Lead Sponsor	Collaborator
Technical University of Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	serum 25-hydroxyvitamin D	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	No