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Cobalamin Absorption From Fortified Food (FL-72)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01399164
First Posted: July 21, 2011
Last Update Posted: October 22, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
USDA, Western Human Nutrition Research Center
  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
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

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01399164


Locations
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
Investigators
Principal Investigator: Lindsay Allen, PhD WHNRC, ARS, University of California Davis
  More Information

Responsible Party: USDA, Western Human Nutrition Research Center
ClinicalTrials.gov Identifier: NCT01399164     History of Changes
Other Study ID Numbers: WHNRC 242621-1
First Submitted: July 19, 2011
First Posted: July 21, 2011
Last Update Posted: October 22, 2013
Last Verified: October 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
Hydroxocobalamin
Vitamin B Complex
Vitamins
Achlorhydria
Avitaminosis
Malnutrition
Nutrition Disorders
Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases
Acid-Base Imbalance
Metabolic Diseases
Micronutrients
Growth Substances
Physiological Effects of Drugs
Hematinics