Cobalamin Absorption From Fortified Food (FL-72)

USDA, Western Human Nutrition Research Center

Status

Completed

Conditions

Achlorhydria

Vitamin B-12 Deficiency

Treatments

Other: 14C-B12 fortified bread

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT01399164

WHNRC 242621-1

Details and patient eligibility

About

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

Full 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.

Enrollment

6 patients

Sex

All

Ages

60+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

good overall health
normal absorptive capacity (controls) or with a serum B12 <300 pg/mL and a pepsinogen I level >100 μg/L (ACs).
All subjects must be available to complete the protocol

Exclusion criteria

Any chronic health disorder
Anemia of any kind
Renal insufficiency
excessive alcohol consumption
Prior GI surgery
Use of OTC or prescription drugs that interfere with B-12 absorption or metabolism
Use of vitamin supplements
Pregnancy or lactation