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Sponsored by: |
Wageningen Centre for Food Sciences |
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Information provided by: | Wageningen University |
ClinicalTrials.gov Identifier: | NCT00353353 |
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 | Intervention |
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Healthy |
Procedure: consumption of fortified bread |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment |
Official Title: | The Bread Trial: a Demonstration Trial to Show Effects of Fortification of Food With Both Folic Acid and Vitamin B12 |
Estimated Enrollment: | 150 |
Study Start Date: | July 2006 |
Study Completion Date: | December 2006 |
During a 12 week period subjects will consume
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.
Ages Eligible for Study: | 50 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Netherlands | |
Wageningen University | |
Wageningen, Netherlands, 6700HD |
Principal Investigator: | Petra Verhoef, PhD | Wageningen University |
Principal Investigator: | Ingeborg Brouwer, PhD | Wageningen University |
Principal Investigator: | Martijn Katan, Professor | Wageningen University |
Study ID Numbers: | 06/02 |
Study First Received: | July 17, 2006 |
Last Updated: | July 6, 2007 |
ClinicalTrials.gov Identifier: | NCT00353353 |
Health Authority: | Netherlands: Medical Ethics Review Committee (METC) |
no specific conditions |
Folic Acid Hydroxocobalamin Vitamin B 12 Healthy |
Vitamin B Complex Growth Substances Vitamins |
Physiological Effects of Drugs Micronutrients Pharmacologic Actions |