The Bread Trial: Effects of Bread Fortified With 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...
Brief Summary
Official Title: “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 Type: Interventional
- Study Design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
Detailed Clinical Trial 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.
Intervention(s) in this Clinical Trial
- Procedure: consumption of fortified bread
Outcome Measures for this Clinical Trial
Primary Measures
- serum B12 status
- serum folate status
Secondary Measures
- erythrocyte folate;
- homocysteine;
- MMA;
- holoTC
Criteria for Participation in this Clinical Trial
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 Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 50 Years
Maximum Age for this Clinical Trial: 75 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers
Clinical Trial Investigator Information
Lead Investigator: Wageningen Centre for Food Sciences Other
Overall Clinical Trial Officials and Contacts
Petra Verhoef, PhD Principal Investigator Wageningen University
Additional Information
Information obtained from ClinicalTrials.gov on February 09, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00353353
Study ID Number: 06/02
ClinicalTrials.gov Identifier: NCT00353353
Health Authority: Netherlands: Medical Ethics Review Committee (METC)
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00353353
