Vitamin B-12 DeficiencyFL-72NCT01399164
Cobalamin Absorption From Fortified Food
A study testing 14C-B12 fortified bread in people with Vitamin B-12 Deficiency and Achlorhydria, run by USDA, Western Human Nutrition Research Center at 1 site in United States.
Trial summary
To determine B12 bioavailability from 14C-B12 fortified bread in healthy subjects and in subjects with proton pump inhibitor induced achlorhydria. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vitamin B-12 Deficiency, Achlorhydria
- What is being tested?
- 14C-B12 fortified bread
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Sep 2013
- Phase
- Interventional
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Western Human Nutrition Center, University of California Davis
Davis, California, 95616
About this study
Official title: Cobalamin Absorption From Fortified Food in Older Adults With and Without Proton Pump Inhibitor Induced Achlorhydria
To determine B12 bioavailability from 14C-B12 fortified bread in healthy subjects and in subjects with proton pump inhibitor induced achlorhydria.
Read the detailed 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.
- Conditions
- Vitamin B-12 Deficiency, Achlorhydria
- Being tested
- 14C-B12 fortified bread
- Keywords
- Vitamin B-12
- Medical subject headings
- Vitamin B 12 Deficiency, Achlorhydria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
14C-B12 fortified breadOther
A single serving of 14C-B12 fortified bread
| Study group | Role | What they receive |
|---|---|---|
| Fortified Bread | Experimental | A single serving of 14C-B12 fortified bread Receives: Other: 14C-B12 fortified bread |
What is being measured
The primary outcome is the main question the study is designed to answer.
B12 bioavailability
B12 bioavailability from 14C-B12 fortified bread
Measured: 8 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2011 (estimated)
- Study startJan 2010
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin B-12 DeficiencyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- USDA, Western Human Nutrition Research Center
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Lindsay Allen, PhD, Principal investigator, WHNRC, ARS, University of California Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01399164
- Sponsor's protocol ID
- WHNRC 242621-1
- Acronym
- FL-72
- Status last verified
- Oct 2013
- First submitted
- 19 Jul 2011
- Last updated
- 22 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cobalamin Absorption From Fortified Food in Older Adults With and Without Proton Pump Inhibitor Induced Achlorhydria
- ClinicalTrials.gov ID
- NCT01399164
- Acronym / sponsor ID
- FL-72 / WHNRC 242621-1
- Conditions
- Vitamin B-12 Deficiency, Achlorhydria
- Keywords
- Vitamin B-12
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- USDA, Western Human Nutrition Research CenterUS federal agency
- Study start
- Jan 2010
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 21 Jul 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.
To determine B12 bioavailability from 14C-B12 fortified bread in healthy subjects and in subjects with proton pump inhibitor induced achlorhydria.
Detailed 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fortified Bread | Experimental | Other: 14C-B12 fortified breadA single serving of 14C-B12 fortified bread |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- Any chronic health disorder
- Anemia of any kind
- Renal insufficiency
- excessive alcohol consumption
- Prior GI surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 14C-B12 fortified breadA single serving of 14C-B12 fortified bread | Other | Fortified Bread |
Primary outcome
B12 bioavailability
Time frame: 8 Days
B12 bioavailability from 14C-B12 fortified bread
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 22 Oct 2013.
- USDA Western Human Nutrition Research CenterLink provided by the sponsor.
Related trials for Vitamin B-12 Deficiency
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingObservational study
Clinical and Laboratory Study of Methylmalonic Acidemia
Organic Acidemia, Methylmalonic Acidemia
Active, not recruitingObservational study
Early Check: Expanded Screening in Newborns
Spinal Muscular Atrophy, Fragile X Syndrome
Active, not recruitingPhase 2/3
Vitamin B12 Supplementation During Pregnancy on Cognitive Development
Pregnancy Related, Vitamin B 12 Deficiency
Active, not recruitingPhase 1
Vitamin B12 Dose Escalation Trial in Pregnancy
Vitamin B 12 Deficiency
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.
Lindsay Allen, PhD principal investigator
WHNRC, ARS, University of California Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 14C-B12 fortified bread in people with Vitamin B-12 Deficiency and Achlorhydria, 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 3 inclusion and 8 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 22 Oct 2013. 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?
B12 bioavailability (time frame: 8 Days). 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 22 Oct 2013.