Cobalamin Absorption From Fortified Food

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01399164

Acronym

FL-72

Enrollment

Registered

2011-07-21

Start date

2010-01-31

Completion date

2013-09-30

Last updated

2013-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Achlorhydria, Vitamin B-12 Deficiency

Keywords

Vitamin B-12

Brief 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.

Interventions

OTHER14C-B12 fortified bread

A single serving of 14C-B12 fortified bread

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

60 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
B12 bioavailability	8 Days	B12 bioavailability from 14C-B12 fortified bread

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026