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

Technical University of Denmark

Status: Completed

Conditions: Healthy

Treatments: Other: Vitamin D fortification

Study type: Interventional

Funder types: Other

Identifiers

NCT01184716

12394

Details and patient eligibility

About

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.

Enrollment: 782 patients

Sex: All

Ages: 4 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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782 participants in 2 patient groups

Vitamin D fortified bread and milk

Active Comparator group

Treatment:

Other: Vitamin D fortification

Non-fortified bread and milk

No Intervention group