Cobalamin Absorption From Fortified Food (FL-72)
Primary Purpose
Vitamin B-12 Deficiency, Achlorhydria
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
14C-B12 fortified bread
Sponsored by
About this trial
This is an interventional basic science trial for Vitamin B-12 Deficiency focused on measuring Vitamin B-12
Eligibility 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
Sites / Locations
- Western Human Nutrition Center, University of California Davis
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Fortified Bread
Arm Description
A single serving of 14C-B12 fortified bread
Outcomes
Primary Outcome Measures
B12 bioavailability
B12 bioavailability from 14C-B12 fortified bread
Secondary Outcome Measures
Full Information
NCT ID
NCT01399164
First Posted
July 19, 2011
Last Updated
October 21, 2013
Sponsor
USDA, Western Human Nutrition Research Center
1. Study Identification
Unique Protocol Identification Number
NCT01399164
Brief Title
Cobalamin Absorption From Fortified Food
Acronym
FL-72
Official Title
Cobalamin Absorption From Fortified Food in Older Adults With and Without Proton Pump Inhibitor Induced Achlorhydria
Study Type
Interventional
2. Study Status
Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
USDA, Western Human Nutrition Research Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To determine B12 bioavailability from 14C-B12 fortified bread in healthy subjects and in subjects with proton pump inhibitor induced achlorhydria.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin B-12 Deficiency, Achlorhydria
Keywords
Vitamin B-12
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fortified Bread
Arm Type
Experimental
Arm Description
A single serving of 14C-B12 fortified bread
Intervention Type
Other
Intervention Name(s)
14C-B12 fortified bread
Intervention Description
A single serving of 14C-B12 fortified bread
Primary Outcome Measure Information:
Title
B12 bioavailability
Description
B12 bioavailability from 14C-B12 fortified bread
Time Frame
8 Days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lindsay Allen, PhD
Organizational Affiliation
WHNRC, ARS, University of California Davis
Official's Role
Principal Investigator
Facility Information:
Facility Name
Western Human Nutrition Center, University of California Davis
City
Davis
State/Province
California
ZIP/Postal Code
95616
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Cobalamin Absorption From Fortified Food
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