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Completed

NCT Number: NCT00353353

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 this fortification strategy on markers of folate and vitamin B12 status.

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Key information

Conditions

Healthy

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wageningen University

Wageningen, 6700HD, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

consumption of fortified bread

Procedure

Primary outcomes

  1. serum B12 status

  2. serum folate status

Secondary outcomes

  1. erythrocyte folate;

  2. homocysteine;

  3. MMA;

  4. holoTC

Sponsors and collaborators

Lead sponsor

Wageningen Centre for Food Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2006
Study completion
2006
First posted
Jul 18, 2006
Registry last updated
Jul 9, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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