Bioavailability of Vitamin B12 From Chicken EggsNCT01366937
Assessment of Vitamin B12 Bioavailability From Egg
An observational study of Bioavailability of Vitamin B12 From Chicken Eggs, run by USDA, Western Human Nutrition Research Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bioavailability of Vitamin B12 From Chicken Eggs
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2007to Sep 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy adults, 18 y or older
Who may be able to join
- normal healthy subjects, adequate B12 status and absorptive capacity and the availability to complete the protocol.
Who cannot join
- any chronic health disorder, anemia of any kind, renal insufficiency, and pregnancy or lactation.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Keywords
- vitamin B12, egg, 14C, fecal excretion
What is being measured
The primary outcome is the main question the study is designed to answer.
Fecal enrichment of 14C
Measured: Over the course of 8 days after dosing with 14C labeled egg
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2011 (estimated)
- Study startAug 2007
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bioavailability of Vitamin B12 From Chicken EggsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- USDA, Western Human Nutrition Research Center
- Sponsor type
- US federal agency
- Investigators
- Linday H Allen, PhD, Principal investigator, ARS, USDA, WHNRCMarjorie G Garrod, PhD, Study chair, ARS, USDA, WHNRC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01366937
- Sponsor's protocol ID
- 200715660-2
- Status last verified
- Aug 2011
- First submitted
- 16 Jan 2009
- Last updated
- 4 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Vitamin B12 Bioavailability From Egg
- ClinicalTrials.gov ID
- NCT01366937
- Acronym / sponsor ID
- 200715660-2
- Keywords
- vitamin B12, egg, 14C, fecal excretion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- USDA, Western Human Nutrition Research CenterUS federal agency
- Study start
- Aug 2007
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 6 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy adults, 18 y or older
Key inclusion criteria (1 listed)
- normal healthy subjects, adequate B12 status and absorptive capacity and the availability to complete the protocol.
Key exclusion criteria (1 listed)
- any chronic health disorder, anemia of any kind, renal insufficiency, and pregnancy or lactation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Fecal enrichment of 14C
Time frame: Over the course of 8 days after dosing with 14C labeled egg
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2011.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Linday H Allen, PhD principal investigator
ARS, USDA, WHNRC
Marjorie G Garrod, PhD study chair
ARS, USDA, WHNRC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bioavailability of Vitamin B12 From Chicken Eggs, run by USDA, Western Human Nutrition Research Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fecal enrichment of 14C (time frame: Over the course of 8 days after dosing with 14C labeled egg). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2011; AzTrials last refreshed its copy on 7 Nov 2026.