Clinical Trials Directory

Trials / Completed

CompletedNCT01399164

Cobalamin Absorption From Fortified Food

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
6 (actual)
Sponsor
USDA, Western Human Nutrition Research Center · Federal
Sex
All
Age
60 Years
Healthy volunteers
Accepted

Summary

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

Detailed description

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.

Conditions

Interventions

TypeNameDescription
OTHER14C-B12 fortified breadA single serving of 14C-B12 fortified bread

Timeline

Start date
2010-01-01
Primary completion
2013-09-01
Completion
2013-09-01
First posted
2011-07-21
Last updated
2013-10-22

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01399164. Inclusion in this directory is not an endorsement.