NCT00353353

Brief Summary

In the Netherlands fortification of food products is not yet mandatory. One of the major arguments of the Dutch Health Council to advise against mandatory fortification is the possibility of masking of a vitamin B12 deficiency. A possible solution to overcome the possibility of masking is: fortification of foods with both folic acid and vitamin B12. In this study we want to assess the effects of this fortification strategy on markers of folate and vitamin B12 status.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Jul 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

July 17, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 18, 2006

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

July 9, 2007

Status Verified

July 1, 2007

First QC Date

July 17, 2006

Last Update Submit

July 6, 2007

Conditions

Healthy

Keywords

no specific conditions

Outcome Measures

Primary Outcomes (2)

  • serum B12 status

  • serum folate status

Secondary Outcomes (4)

  • erythrocyte folate;

  • homocysteine;

  • MMA;

  • holoTC

Interventions

consumption of fortified breadPROCEDURE

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age 50-75y

You may not qualify if:

  • consumption of \< 3 slices of bread/day
  • use of B-vitamins in the period three months prior to the study
  • treatment with B12-injections in the last 5y
  • illness or use of medication interfering with folate or vitamin B12 metabolism

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wageningen University

Wageningen, 6700HD, Netherlands

Location

Related Publications (1)

  • Winkels RM, Brouwer IA, Clarke R, Katan MB, Verhoef P. Bread cofortified with folic acid and vitamin B-12 improves the folate and vitamin B-12 status of healthy older people: a randomized controlled trial. Am J Clin Nutr. 2008 Aug;88(2):348-55. doi: 10.1093/ajcn/88.2.348.

    PMID: 18689370DERIVED

Study Officials

  • Petra Verhoef, PhD

    Wageningen University

    PRINCIPAL INVESTIGATOR

  • Ingeborg Brouwer, PhD

    Wageningen University

    PRINCIPAL INVESTIGATOR

  • Martijn Katan, Professor

    Wageningen University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 17, 2006

First Posted

July 18, 2006

Study Start

July 1, 2006

Study Completion

December 1, 2006

Last Updated

July 9, 2007

Record last verified: 2007-07

Locations

NL(1)