Assessment of Vitamin B12 Bioavailability From Egg

This study has been completed.
Sponsor:
Information provided by:
USDA, Western Human Nutrition Research Center
ClinicalTrials.gov Identifier:
NCT01366937
First received: January 16, 2009
Last updated: August 3, 2011
Last verified: August 2011
  Purpose

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
Bioavailability of Vitamin B12 From Chicken Eggs

Study Type: Observational
Study Design: Observational Model: Case-Only
Official Title: Assessment of Vitamin B12 Bioavailability From Egg

Resource links provided by NLM:


Further study details as provided by USDA, Western Human Nutrition Research Center:

Primary Outcome Measures:
  • Fecal enrichment of 14C [ Time Frame: Over the course of 8 days after dosing with 14C labeled egg ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Plasma, serum, buffy coat, urine, stool


Estimated Enrollment: 10
Study Start Date: August 2007
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Healthy adults, 18 y or older

Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01366937

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

No publications provided

Responsible Party: Lindsay H. Allen, ARS USDA WHNRC
ClinicalTrials.gov Identifier: NCT01366937     History of Changes
Other Study ID Numbers: 200715660-2
Study First Received: January 16, 2009
Last Updated: August 3, 2011
Health Authority: United States: Federal Government

Keywords provided by USDA, Western Human Nutrition Research Center:
vitamin B12
egg
14C
fecal excretion

Additional relevant MeSH terms:
Vitamin B 12
Hydroxocobalamin
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Hematinics
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 01, 2014