Cobalamin Absorption From Fortified Food

Not Applicable

Completed

• Conditions: Vitamin B-12 Deficiency; Achlorhydria
• Interventions: Other: 14C-B12 fortified bread

• Registration Number: NCT01399164
• Lead Sponsor: USDA, Western Human Nutrition Research Center

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.

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2011-07-19
• Study First Submitted QC: 2011-07-19
• Study First Posted: 2011-07-21
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-21
• Last Update Posted: 2013-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Fortified Bread	14C-B12 fortified bread	A single serving of 14C-B12 fortified bread

Primary Outcome Measures

Name	Time	Method
B12 bioavailability	8 Days	B12 bioavailability from 14C-B12 fortified bread

Trial Locations

Locations (1)

Western Human Nutrition Center, University of California Davis; 🇺🇸 Davis, California, United States