Clinical Trial: Cobalamin Absorption From Fortified Food

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Cobalamin Absorption From Fortified Food in Older Adults With and Without Proton Pump Inhibitor Induced Achlorhydria

Brief Summary: To determine B12 bioavailability from 14C-B12 fortified bread in healthy subjects and in subjects with proton pump inhibitor induced achlorhydria.

Detailed Summary: Cobalamin (vitamin B12) deficiency is highly prevalent in the US and worldwide. Deficiency is most common in the elderly, with an average prevalence ≈25% over age 60 y. About 40% of older persons with low serum cobalamin have food cobalamin malabsorption (F-CM), in which gastric atrophy/achlorhydria and/or dysfunction is implicated. Because of the prevalence of deficiency in those over age 60 y, it is generally recommended that the elderly consume a higher proportion of their cobalamin from fortified foods than what is recommended for younger people. However there is considerable debate about whether crystalline cobalamin is absorbed as well by the elderly with F-CM as it is by younger people, especially if it is added as a fortificant to food. The data to be collected in this study will provide information useful to on-going deliberations concerning the future fortification of wheat flour with vitamin B12 in the United States.
Sponsor: USDA, Western Human Nutrition Research Center

Current Primary Outcome: B12 bioavailability [ Time Frame: 8 Days ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: USDA, Western Human Nutrition Research Center

Dates:
Date Received: July 19, 2011
Date Started: January 2010
Date Completion:
Last Updated: October 21, 2013
Last Verified: October 2013