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

July 6, 2007 updated by: Wageningen Centre for Food Sciences

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Wageningen, Netherlands, 6700HD
        • Wageningen University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
serum B12 status
serum folate status

Secondary Outcome Measures

Outcome Measure
erythrocyte folate;
homocysteine;
MMA;
holoTC

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wageningen Centre for Food Sciences

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2006

Study Completion (Actual)

December 1, 2006

Study Registration Dates

First Submitted

July 17, 2006

First Submitted That Met QC Criteria

July 17, 2006

First Posted (Estimate)

July 18, 2006

Study Record Updates

Last Update Posted (Estimate)

July 9, 2007

Last Update Submitted That Met QC Criteria

July 6, 2007

Last Verified

July 1, 2007

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 06/02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Healthy

Clinical Trials on consumption of fortified bread

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Albania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe