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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00353353
Recruitment Status : Completed
First Posted : July 18, 2006
Last Update Posted : July 9, 2007
Sponsor:
Information provided by:
Wageningen University

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.

Condition or disease Intervention/treatment Phase
Healthy Procedure: consumption of fortified bread Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: The Bread Trial: a Demonstration Trial to Show Effects of Fortification of Food With Both Folic Acid and Vitamin B12
Study Start Date : July 2006
Actual Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Folic acid




Primary Outcome Measures :
  1. serum B12 status
  2. serum folate status

Secondary Outcome Measures :
  1. erythrocyte folate;
  2. homocysteine;
  3. MMA;
  4. holoTC


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00353353


Locations
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Netherlands
Wageningen University
Wageningen, Netherlands, 6700HD
Sponsors and Collaborators
Wageningen Centre for Food Sciences
Investigators
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Principal Investigator: Petra Verhoef, PhD Wageningen University
Principal Investigator: Ingeborg Brouwer, PhD Wageningen University
Principal Investigator: Martijn Katan, Professor Wageningen University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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ClinicalTrials.gov Identifier: NCT00353353     History of Changes
Other Study ID Numbers: 06/02
First Posted: July 18, 2006    Key Record Dates
Last Update Posted: July 9, 2007
Last Verified: July 2007

Keywords provided by Wageningen University:
no specific conditions

Additional relevant MeSH terms:
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Folic Acid
Hydroxocobalamin
Vitamin B Complex
Vitamin B 12
Hematinics
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs