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Cobalamin Absorption From Fortified Food (FL-72)

This study has been completed.
Information provided by (Responsible Party):
USDA, Western Human Nutrition Research Center Identifier:
First received: July 19, 2011
Last updated: October 21, 2013
Last verified: October 2013
To determine B12 bioavailability from 14C-B12 fortified bread in healthy subjects and in subjects with proton pump inhibitor induced achlorhydria.

Condition Intervention
Vitamin B-12 Deficiency
Other: 14C-B12 fortified bread

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Cobalamin Absorption From Fortified Food in Older Adults With and Without Proton Pump Inhibitor Induced Achlorhydria

Resource links provided by NLM:

Further study details as provided by USDA, Western Human Nutrition Research Center:

Primary Outcome Measures:
  • B12 bioavailability [ Time Frame: 8 Days ]
    B12 bioavailability from 14C-B12 fortified bread

Enrollment: 6
Study Start Date: January 2010
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fortified Bread
A single serving of 14C-B12 fortified bread
Other: 14C-B12 fortified bread
A single serving of 14C-B12 fortified bread

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.

Ages Eligible for Study:   60 Years and older   (Adult, Senior)
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
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Please refer to this study by its identifier: NCT01399164

United States, California
Western Human Nutrition Center, University of California Davis
Davis, California, United States, 95616
Sponsors and Collaborators
USDA, Western Human Nutrition Research Center
Principal Investigator: Lindsay Allen, PhD WHNRC, ARS, University of California Davis
  More Information

Responsible Party: USDA, Western Human Nutrition Research Center Identifier: NCT01399164     History of Changes
Other Study ID Numbers: WHNRC 242621-1
Study First Received: July 19, 2011
Last Updated: October 21, 2013

Keywords provided by USDA, Western Human Nutrition Research Center:
Vitamin B-12

Additional relevant MeSH terms:
Vitamin B 12 Deficiency
Vitamin B Deficiency
Deficiency Diseases
Vitamin B 12
Vitamin B Complex
Nutrition Disorders
Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases
Acid-Base Imbalance
Metabolic Diseases
Growth Substances
Physiological Effects of Drugs
Hematinics processed this record on May 25, 2017