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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00353353
• Other study ID #: 06/02
• Status: Completed
• Phase: N/A
• First received: July 17, 2006
• Last updated: July 6, 2007
• Start date: July 2006
• Est. completion date: December 2006

Study information

• Verified date: July 2007
• Source: Wageningen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: December 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 75 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Healthy

Intervention

Procedure:
• consumption of fortified bread

Locations

Country	Name	City	State
Netherlands	Wageningen University	Wageningen

Sponsors (1)

Lead Sponsor	Collaborator
Wageningen Centre for Food Sciences

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	serum B12 status
Primary	serum folate status
Secondary	erythrocyte folate;
Secondary	homocysteine;
Secondary	MMA;
Secondary	holoTC