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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00353353
Enrollment
150
Registered
2006-07-18
Start date
2006-07-31
Completion date
2006-12-31
Last updated
2007-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

no specific conditions

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.

Interventions

PROCEDUREconsumption of fortified bread

Sponsors

Wageningen Centre for Food Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
50 Years to 75 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
serum B12 status
serum folate status

Secondary

MeasureTime frame
erythrocyte folate;
homocysteine;
MMA;
holoTC

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 5, 2026