Cobalamin Absorption From Fortified Food

Achlorhydria Clinical Trial

— FL-72  

Official title:

Cobalamin Absorption From Fortified Food in Older Adults With and Without Proton Pump Inhibitor Induced Achlorhydria

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01399164
• Other study ID #: WHNRC 242621-1
• Status: Completed
• Phase: N/A
• First received: July 19, 2011
• Last updated: October 21, 2013
• Start date: January 2010
• Est. completion date: September 2013

Study information

• Verified date: October 2013
• Source: USDA, Western Human Nutrition Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

To determine B12 bioavailability from 14C-B12 fortified bread in healthy subjects and in subjects with proton pump inhibitor induced achlorhydria.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 60 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Achlorhydria
• Vitamin B 12 Deficiency
• Vitamin B-12 Deficiency

Intervention

Other:
• 14C-B12 fortified bread
A single serving of 14C-B12 fortified bread

Locations

Country	Name	City	State
United States	Western Human Nutrition Center, University of California Davis	Davis	California

Sponsors (1)

Lead Sponsor	Collaborator
USDA, Western Human Nutrition Research Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	B12 bioavailability	B12 bioavailability from 14C-B12 fortified bread	8 Days	No