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Cobalamin Absorption From Fortified Food (FL-72)

This study is currently recruiting participants.
Verified March 2013 by USDA, Western Human Nutrition Research Center
Sponsor:
Information provided by (Responsible Party):
USDA, Western Human Nutrition Research Center
ClinicalTrials.gov Identifier:
NCT01399164
First received: July 19, 2011
Last updated: March 21, 2013
Last verified: March 2013
History of Changes
  Purpose

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
Achlorhydria
 Other: 14C-B12 fortified bread

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
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:

MedlinePlus related topics: B Vitamins
U.S. FDA Resources

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

Primary Outcome Measures:
  • B12 bioavailability [ Time Frame: 8 Days ] [ Designated as safety issue: No ]
    B12 bioavailability from 14C-B12 fortified bread


Estimated Enrollment: 10
Study Start Date: January 2010
Estimated Study Completion Date: September 2013
Estimated 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.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01399164

Contacts
Contact: Mary Ellen Rivera (530) 754-5248 maryellen.rivera@ars.usda.gov

Locations
United States, California
Western Human Nutrition Center, University of California Davis Recruiting
Davis, California, United States, 95616
Contact: Ellen Bonnel     530-752-4184     ellen.bonnel@ars.usda.gov    
Principal Investigator: Lindsay Allen, PhD            
Sponsors and Collaborators
USDA, Western Human Nutrition Research Center
Investigators
Principal Investigator: Lindsay Allen, PhD WHNRC, ARS, University of California Davis
  More Information

No publications provided

Responsible Party: USDA, Western Human Nutrition Research Center
ClinicalTrials.gov Identifier: NCT01399164     History of Changes
Other Study ID Numbers: WHNRC 242621-1
Study First Received: July 19, 2011
Last Updated: March 21, 2013
Health Authority: United States: Federal Government
United States: Food and Drug Administration
United States: Institutional Review Board

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

Additional relevant MeSH terms:
Achlorhydria
Vitamin B 12 Deficiency
Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases
Acid-Base Imbalance
Metabolic Diseases
Vitamin B Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
 Nutrition Disorders
Vitamin B 12
Proton Pump Inhibitors
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 19, 2013