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

NCT01184716 | Completed

• 1 other identifier: 12394
• Study Type: interventional
• Target: 782
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Keywords

Vitamin D status (serum 25-hydroxyvitamin D)

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Vitamin D fortified bread and milk

ACTIVE COMPARATOR

Other: Vitamin D fortification

Non-fortified bread and milk

NO INTERVENTION

Interventions

Vitamin D fortification OTHER

Bread and milk fortified with vitamin D3

Vitamin D fortified bread and milk

Eligibility Criteria

• Age: 4 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Use of medication (including dietary supplements with high levels of vitamin D)
• Diseases which influence vitamin D metabolism
• Pregnancy

Sponsors & Collaborators

• Technical University of Denmark: lead

Study Sites (1)

Division of Nutrition, National Food Institute, Technical University of Denmark

Søborg, 2860, Denmark

Location

Related Publications (1)

• Nissen J, Vogel U, Ravn-Haren G, Andersen EW, Madsen KH, Nexo BA, Andersen R, Mejborn H, Bjerrum PJ, Rasmussen LB, Wulf HC. Common variants in CYP2R1 and GC genes are both determinants of serum 25-hydroxyvitamin D concentrations after UVB irradiation and after consumption of vitamin D(3)-fortified bread and milk during winter in Denmark. Am J Clin Nutr. 2015 Jan;101(1):218-27. doi: 10.3945/ajcn.114.092148. Epub 2014 Nov 5.

  PMID: 25527766 DERIVED

Study Officials

• Lone B Rasmussen, M.Sc., Ph.D.

  National Food Institute, DTU

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 17, 2010
• First Posted: August 19, 2010
• Study Start: September 1, 2010
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: May 9, 2011

Record last verified: 2011-05

Locations

DK (1)