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Assessment of Vitamin B12 Bioavailability From Egg

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ClinicalTrials.gov Identifier: NCT01366937
Recruitment Status : Completed
First Posted : June 6, 2011
Last Update Posted : August 4, 2011
Information provided by:
USDA, Western Human Nutrition Research Center

Brief Summary:

The hypothesis of this study is that chicken eggs can be enriched in vivo with 14C-B12 and fed to healthy human subjects to determine B12 bioavailability from eggs.

The goal of this research is to enrich eggs in vivo with radioactively labeled vitamin B12 to a level that allows us to feed the enriched eggs to humans and determine how much of the vitamin B12 is digested and absorbed into the body. This will tell us if eggs are a good dietary source of vitamin B12. Importantly, sensitive technology available at the Lawrence Livermore National Laboratories allows us to measure very low amounts of radioactive vitamin B12. This allows us to do this experiment with a level of radioactive B12 that is not harmful to animals or humans. The results of the investigators first experiment indicate that the investigators can inject radioactively labeled vitamin B12 into a laying hen and detect the radioactive vitamin B12 in the eggs at a level sufficient for feeding to humans in a bioavailability study.

Condition or disease
Bioavailability of Vitamin B12 From Chicken Eggs

Study Type : Observational
Estimated Enrollment : 10 participants
Observational Model: Case-Only
Official Title: Assessment of Vitamin B12 Bioavailability From Egg
Study Start Date : August 2007
Primary Completion Date : September 2009
Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: B Vitamins
U.S. FDA Resources

Primary Outcome Measures :
  1. Fecal enrichment of 14C [ Time Frame: Over the course of 8 days after dosing with 14C labeled egg ]

Biospecimen Retention:   Samples With DNA
Plasma, serum, buffy coat, urine, stool

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy adults, 18 y or older

Inclusion Criteria:

  • normal healthy subjects, adequate B12 status and absorptive capacity and the availability to complete the protocol.

Exclusion Criteria:

  • any chronic health disorder, anemia of any kind, renal insufficiency, and pregnancy or lactation.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01366937

United States, California
Usda, Ars, Whnrc
Davis, California, United States, 95616
Sponsors and Collaborators
USDA, Western Human Nutrition Research Center
Principal Investigator: Linday H Allen, PhD ARS, USDA, WHNRC
Study Chair: Marjorie G Garrod, PhD ARS, USDA, WHNRC

Responsible Party: Lindsay H. Allen, ARS USDA WHNRC
ClinicalTrials.gov Identifier: NCT01366937     History of Changes
Other Study ID Numbers: 200715660-2
First Posted: June 6, 2011    Key Record Dates
Last Update Posted: August 4, 2011
Last Verified: August 2011

Keywords provided by USDA, Western Human Nutrition Research Center:
vitamin B12
fecal excretion

Additional relevant MeSH terms:
Vitamin B 12
Vitamin B Complex
Growth Substances
Physiological Effects of Drugs