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

This study has been completed.

Sponsor:

Information provided by:

Wageningen University

ClinicalTrials.gov Identifier:

NCT00353353

First received: July 17, 2006

Last updated: July 6, 2007

Last verified: July 2007

History of Changes

Tracking Information

First Received Date ^ICMJE

July 17, 2006

Last Updated Date

July 6, 2007

Start Date ^ICMJE

July 2006

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

serum B12 status
serum folate status

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00353353 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

erythrocyte folate;
homocysteine;
MMA;
holoTC

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Original Other Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

The Bread Trial: a Demonstration Trial to Show Effects of Fortification of Food With Both Folic Acid and Vitamin B12

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.

Detailed Description

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.

Study Type ^ICMJE

Interventional

Study Phase

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention

Condition ^ICMJE

Healthy

Intervention ^ICMJE

Procedure: consumption of fortified bread

Study Arm (s)

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

150

Completion Date

December 2006

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

50 Years to 75 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Netherlands

Administrative Information

NCT Number ^ICMJE

NCT00353353

Other Study ID Numbers ^ICMJE

06/02

Has Data Monitoring Committee

Responsible Party

Study Sponsor ^ICMJE

Wageningen Centre for Food Sciences

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:	Petra Verhoef, PhD	Wageningen University
Principal Investigator:	Ingeborg Brouwer, PhD	Wageningen University
Principal Investigator:	Martijn Katan, Professor	Wageningen University

Information Provided By

Wageningen University

Verification Date

July 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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