- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01399164
Cobalamin Absorption From Fortified Food (FL-72)
October 21, 2013 updated by: USDA, Western Human Nutrition Research Center
Cobalamin Absorption From Fortified Food in Older Adults With and Without Proton Pump Inhibitor Induced Achlorhydria
To determine B12 bioavailability from 14C-B12 fortified bread in healthy subjects and in subjects with proton pump inhibitor induced achlorhydria.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
6
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Davis, California, United States, 95616
- Western Human Nutrition Center, University of California Davis
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Fortified Bread
A single serving of 14C-B12 fortified bread
|
A single serving of 14C-B12 fortified bread
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
B12 bioavailability
Time Frame: 8 Days
|
B12 bioavailability from 14C-B12 fortified bread
|
8 Days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Lindsay Allen, PhD, WHNRC, ARS, University of California Davis
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2010
Primary Completion (Actual)
September 1, 2013
Study Completion (Actual)
September 1, 2013
Study Registration Dates
First Submitted
July 19, 2011
First Submitted That Met QC Criteria
July 19, 2011
First Posted (Estimate)
July 21, 2011
Study Record Updates
Last Update Posted (Estimate)
October 22, 2013
Last Update Submitted That Met QC Criteria
October 21, 2013
Last Verified
October 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- WHNRC 242621-1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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