The Bread Trial: Effects of Bread Fortified With Folic Acid and Vitamin B12 - Full Text View

Sponsored by:	Wageningen Centre for Food Sciences
Information provided by:	Wageningen University
ClinicalTrials.gov Identifier:	NCT00353353

Purpose

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.

Condition	Intervention
Healthy	Procedure: consumption of fortified bread

Drug Information available for: Folic acid Vitamin B 12 Hydroxocobalamin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment
Official Title:	The Bread Trial: a Demonstration Trial to Show Effects of Fortification of Food With Both Folic Acid and Vitamin B12

Further study details as provided by Wageningen University:

Primary Outcome Measures:

serum B12 status
serum folate status

Secondary Outcome Measures:

erythrocyte folate;
homocysteine;
MMA;
holoTC

Estimated Enrollment:	150
Study Start Date:	July 2006
Study Completion Date:	December 2006

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.

Eligibility

Ages Eligible for Study:	50 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00353353

Locations

Netherlands
Wageningen University
Wageningen, Netherlands, 6700HD

Sponsors and Collaborators

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

More Information

Study ID Numbers:	06/02
Study First Received:	July 17, 2006
Last Updated:	July 6, 2007
ClinicalTrials.gov Identifier:	NCT00353353
Health Authority:	Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Wageningen University:

no specific conditions

Study placed in the following topic categories:

Folic Acid
Hydroxocobalamin
Vitamin B 12
Healthy

Additional relevant MeSH terms:

Vitamin B Complex
Growth Substances
Vitamins

Physiological Effects of Drugs
Micronutrients
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009