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The Bread Trial: Effects of Bread Fortified With Folic Acid and Vitamin B12

NCT ID: NCT00353353

Last Updated: 2007-07-09

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

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Study Completion Date

2006-12-31

Brief Summary

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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.

Detailed Description

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During a 12 week period subjects will consume

* bread fortified with folic acid and vitamin B12 or
* placebo bread (not fortified)

Bread consumption has to be at least 3 slices per day, fortification level is 100mcg folic acid and 6mcg vitamin B12 per 3 slices.

We will study the effect of this fortification strategy on markers of folate and vitamin B12 status.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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consumption of fortified bread

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* age 50-75y

Exclusion Criteria

* 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
Minimum Eligible Age

50 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Wageningen Centre for Food Sciences

OTHER

Sponsor Role lead

Principal Investigators

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Petra Verhoef, PhD

Role: PRINCIPAL_INVESTIGATOR

Wageningen University

Ingeborg Brouwer, PhD

Role: PRINCIPAL_INVESTIGATOR

Wageningen University

Martijn Katan, Professor

Role: PRINCIPAL_INVESTIGATOR

Wageningen University

Locations

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Wageningen University

Wageningen, , Netherlands

Site Status

Countries

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Netherlands

References

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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.

Reference Type DERIVED
PMID: 18689370 (View on PubMed)

Other Identifiers

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06/02

Identifier Type: -

Identifier Source: org_study_id