PregnancyNCT00730093
The Absorption of Vitamin B12 Among Healthy Pregnant Women
A study testing B12 vitamin (Cyanocobalamin) in people with Pregnancy, run by University of Aarhus at 1 site in Denmark.
Trial summary
During pregnancy the woman uses more vitamin B12, but we do not know, whether it is through increased absorption or it eats into the womans vitamin B12 deposit . Sufficient B-vitamin is crucial for the normal development af foetus during pregnancy. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- What is being tested?
- B12 vitamin (Cyanocobalamin)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2008to Aug 2009
- 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 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- the 13 week of gestation +/- 1 week (only fore pregnant women)
- Between 20- 40 years
- Northern European
- abel to read and understand danish
Who cannot join
- treatment with vitamin B12 within the last 5 years
- daily intake of vitamins that contain more than 1µg vitamin B12
- infectious disease
- systemic disease
- daily use of medicine that interferes with vitamin B12
Trial locations and contacts
1 site in 1 country.
About this study
During pregnancy the woman uses more vitamin B12, but we do not know, whether it is through increased absorption or it eats into the womans vitamin B12 deposit . Sufficient B-vitamin is crucial for the normal development af foetus during pregnancy.
In Denmark the National Board of Health recommend an intake of Folic Acid, from the day the woman wishes to be pregnant and to the 12. week of gestation, but there is no recommendation for vitamin B12. We will measure the vitamin B12 absorption with a new non-radioactive test, CobaSorb.
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- Conditions
- Pregnancy
- Being tested
- B12 vitamin (Cyanocobalamin)
- Keywords
- Vitamin B12 absorption, Pregnancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
B12 vitamin (Cyanocobalamin)Dietary supplement
Arm A: B12 vitamin (Cyanocobalamin)
| Study group | Role | What they receive |
|---|---|---|
| A | Other | Not described Receives: Dietary Supplement: B12 vitamin (Cyanocobalamin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in vitamin B12 absorption during pregnancy, measured with CobaSorb.
Measured: 9 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2008 (estimated)
- Study startAug 2008
- Primary completionJul 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Investigators
- Ebba Nexø, Professor, Study chair, Aarhus Universitetshospital, Aarhus Sygehus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00730093
- Sponsor's protocol ID
- BH12008
- Status last verified
- Aug 2009
- First submitted
- 11 Jul 2008
- Last updated
- 6 Aug 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Absorption of Vitamin B12 Among Healthy Pregnant Women
- ClinicalTrials.gov ID
- NCT00730093
- Acronym / sponsor ID
- BH12008
- Conditions
- Pregnancy
- Keywords
- Vitamin B12 absorption, Pregnancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Jul 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 8 Aug 2008 (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.
During pregnancy the woman uses more vitamin B12, but we do not know, whether it is through increased absorption or it eats into the womans vitamin B12 deposit . Sufficient B-vitamin is crucial for the normal development af foetus during pregnancy.
In Denmark the National Board of Health recommend an intake of Folic Acid, from the day the woman wishes to be pregnant and to the 12. week of gestation, but there is no recommendation for vitamin B12. We will measure the vitamin B12 absorption with a new non-radioactive test, CobaSorb.
.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Other | Dietary Supplement: B12 vitamin (Cyanocobalamin) |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- the 13 week of gestation +/- 1 week (only fore pregnant women)
- Between 20- 40 years
- Northern European
- abel to read and understand danish
Key exclusion criteria (5 listed)
- treatment with vitamin B12 within the last 5 years
- daily intake of vitamins that contain more than 1µg vitamin B12
- infectious disease
- systemic disease
- daily use of medicine that interferes with vitamin B12
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 |
|---|---|---|
| B12 vitamin (Cyanocobalamin)Arm A: B12 vitamin (Cyanocobalamin) | Dietary supplement | A |
Primary outcome
Change in vitamin B12 absorption during pregnancy, measured with CobaSorb.
Time frame: 9 month
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 6 Aug 2009.
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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.
Ebba Nexø, Professor study chair
Aarhus Universitetshospital, Aarhus Sygehus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing B12 vitamin (Cyanocobalamin) in people with Pregnancy, run by University of Aarhus at 1 site in Denmark.
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 4 inclusion and 5 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 6 Aug 2009. 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 Denmark. 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?
Change in vitamin B12 absorption during pregnancy, measured with CobaSorb. (time frame: 9 month). 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 6 Aug 2009.