Viewing Study NCT00353353



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Study NCT ID: NCT00353353
Status: COMPLETED
Last Update Posted: 2007-07-09
First Post: 2006-07-17

Brief Title: The Bread Trial Effects of Bread Fortified With Folic Acid and Vitamin B12
Sponsor: Wageningen Centre for Food Sciences
Organization: Wageningen University

Study Overview

Official Title: The Bread Trial a Demonstration Trial to Show Effects of Fortification of Food With Both Folic Acid and Vitamin B12
Status: COMPLETED
Status Verified Date: 2007-07
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None