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FL-72: Cobalamin Absorption From Fortified Food

Sponsor
USDA, Western Human Nutrition Research Center (U.S. Fed)
Overall Status
Completed
CT.gov ID
NCT01399164
Collaborator
(none)
6
Enrollment
1
Location
1
Arm
44
Duration (Months)
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Other: 14C-B12 fortified bread
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
6 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Cobalamin Absorption From Fortified Food in Older Adults With and Without Proton Pump Inhibitor Induced Achlorhydria
Study Start Date :
Jan 1, 2010
Actual Primary Completion Date :
Sep 1, 2013
Actual Study Completion Date :
Sep 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: Fortified Bread

A single serving of 14C-B12 fortified bread

Other: 14C-B12 fortified bread
A single serving of 14C-B12 fortified bread

Outcome Measures

Primary Outcome Measures

  1. B12 bioavailability [8 Days]

    B12 bioavailability from 14C-B12 fortified bread

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Western Human Nutrition Center, University of California Davis Davis California United States 95616

Sponsors and Collaborators

  • USDA, Western Human Nutrition Research Center

Investigators

  • Principal Investigator: Lindsay Allen, PhD, WHNRC, ARS, University of California Davis

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
USDA, Western Human Nutrition Research Center
ClinicalTrials.gov Identifier:
NCT01399164
Other Study ID Numbers:
  • WHNRC 242621-1
First Posted:
Jul 21, 2011
Last Update Posted:
Oct 22, 2013
Last Verified:
Oct 1, 2013
Keywords provided by USDA, Western Human Nutrition Research Center
Vitamin B-12
Additional relevant MeSH terms:
Achlorhydria
Vitamin B 12 Deficiency

Study Results

No Results Posted as of Oct 22, 2013