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Cobalamin Absorption From Fortified Food

NCT ID: NCT01399164

Last Updated: 2013-10-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2013-09-30

Brief Summary

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

Detailed Description

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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

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Vitamin B-12 Deficiency Achlorhydria

Keywords

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Vitamin B-12

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Fortified Bread

A single serving of 14C-B12 fortified bread

Group Type EXPERIMENTAL

14C-B12 fortified bread

Intervention Type OTHER

A single serving of 14C-B12 fortified bread

Interventions

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14C-B12 fortified bread

A single serving of 14C-B12 fortified bread

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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USDA, Western Human Nutrition Research Center

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lindsay Allen, PhD

Role: PRINCIPAL_INVESTIGATOR

WHNRC, ARS, University of California Davis

Locations

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Western Human Nutrition Center, University of California Davis

Davis, California, United States

Site Status

Countries

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United States

Other Identifiers

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WHNRC 242621-1

Identifier Type: -

Identifier Source: org_study_id