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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

782 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2011-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Vitamin D fortified bread and milk

Group Type ACTIVE_COMPARATOR

Vitamin D fortification

Intervention Type OTHER

Bread and milk fortified with vitamin D3

Non-fortified bread and milk

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Vitamin D fortification

Bread and milk fortified with vitamin D3

Intervention Type OTHER

Eligibility Criteria

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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.