View Clinical Trial (Medical Research Study)
Cobalamin Absorption From Fortified Food in Older Adults With and Without Proton Pump Inhibitor Induced Achlorhydria
| City: |
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Davis |
| State: |
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California |
| Zip Code: |
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95616 |
| Conditions: |
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Vitamin B-12 Deficiency - Achlorhydria |
| Purpose: |
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To determine B12 bioavailability from 14C-B12 fortified bread in healthy subjects and in
subjects with proton pump inhibitor induced achlorhydria.
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| Study Summary: |
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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.
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| Criteria: |
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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
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| NCT ID: |
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NCT01399164 |
| Primary Contact: |
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Principal Investigator
Lindsay Allen, PhD
WHNRC, ARS, University of California Davis
Mary Ellen Rivera
Phone: (530) 754-5248
Email: maryellen.rivera@ars.usda.gov
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| Backup Contact: |
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N/A |
| Location Contact: |
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Davis, California 95616
United States
Ellen Bonnel
Phone: 530-752-4184
Email: ellen.bonnel@ars.usda.gov
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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June 18, 2013 |
| Modifications to this listing: |
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