Cobalamin Absorption From Fortified Food (FL-72)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

USDA, Western Human Nutrition Research Center

ClinicalTrials.gov Identifier:

NCT01399164

First received: July 19, 2011

Last updated: October 21, 2013

Last verified: October 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 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

Drug Information available for: Cyanocobalamin Cobalamin Hydroxocobalamin

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 ]
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


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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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


Achlorhydria Vitamin B 12 Deficiency Vitamin B Deficiency Avitaminosis Deficiency Diseases Malnutrition Nutrition Disorders Stomach Diseases Gastrointestinal Diseases Digestive System Diseases	Acid-Base Imbalance Metabolic Diseases Vitamin B 12 Hydroxocobalamin Vitamin B Complex Vitamins Micronutrients Growth Substances Physiological Effects of Drugs Hematinics

ClinicalTrials.gov processed this record on July 11, 2017

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