The Effect of Vitamin D Fortification of Bread and Milk in Danish Families (VitMaD)
This study has been completed.
Sponsor:
Technical University of Denmark
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
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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 May 23, 2013