Skip to main content
OpenTrials
Completed

NCT Number: NCT01399164

Cobalamin Absorption From Fortified Food

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Western Human Nutrition Center, University of California Davis

Davis, California, 95616, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

14C-B12 fortified bread

Other

A single serving of 14C-B12 fortified bread

Primary outcomes

  1. B12 bioavailability

    Time frame: 8 Days

    B12 bioavailability from 14C-B12 fortified bread

Sponsors and collaborators

Lead sponsor

USDA, Western Human Nutrition Research Center

Fed

Registry information

Official study title

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

Acronym: FL-72

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Jul 21, 2011
Registry last updated
Oct 22, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.