Vitamin B12 DeficiencyNCT00467623
Holotranscobalamin Remains Unchanged During Pregnancy
An observational study of Vitamin B12 Deficiency, run by University of Aarhus at 1 site in Denmark.
Trial summary
Background and objective: Plasma cobalamins decrease during pregnancy but it is not fully elucidated how this is reflected in the total and cobalamin saturated transport proteins, transcobalamin (total TC, holoTC) and haptocorrin (total HC, holoHC). TC transports cobalamin into the cells. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vitamin B12 Deficiency
- How many people
- 150 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 1995to Dec 1997
- 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 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Danish healthy Caucasian women >18 years of age with previous uncomplicated pregnancies and deliveries and presently with a normal pregnancy.
Who cannot join
- >4 cigarettes smoked per day,
- Treatment with vitamin B12, folic acid or acetyl salicylic acid,
- Impaired renal function and clinically significant vaginal haemorrhage before first visit as well as blood haemoglobin <6.4 mmol/L at first visit.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Holotranscobalamin Remains Unchanged During Pregnancy. Longitudinal Changes of Cobalamins and Its Binding Proteins During Pregnancy and Postpartum
Background and objective: Plasma cobalamins decrease during pregnancy but it is not fully elucidated how this is reflected in the total and cobalamin saturated transport proteins, transcobalamin (total TC, holoTC) and haptocorrin (total HC, holoHC). TC transports cobalamin into the cells. The function of HC is unknown, but in contrast to TC it binds both cobalamins and cobalamin analogues.
Design and methods: Healthy pregnant women (N=141) had blood samples drawn at 18th, 32nd, 39th gestation week and 8 weeks postpartum. The protein moiety of TC and HC (total and holo) was measured by in-house ELISA methods.
Read the detailed description
Background and objective: Plasma cobalamins decrease during pregnancy but it is not fully elucidated how this is reflected in the total and cobalamin saturated transport proteins, transcobalamin (total TC, holoTC) and haptocorrin (total HC, holoHC). TC transports cobalamin into the cells. The function of HC is unknown, but in contrast to TC it binds both cobalamins and cobalamin analogues.
Design and methods: Healthy pregnant women (N=141) had blood samples drawn at 18th, 32nd, 39th gestation week and 8 weeks postpartum. The protein moiety of TC and HC (total and holo) was measured by in-house ELISA methods.
- Conditions
- Vitamin B12 Deficiency
- Keywords
- Pregnancy, holotranscobalamin, cobalamin, vitamin B12 analogues, reference interval
- Medical subject headings
- Vitamin B 12 Deficiency
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2007 (estimated)
- Study startJan 1995
- Study completionDec 1997
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin B12 DeficiencyStudies 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 150 participants
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen
- Investigators
- Nils Milman, MD, Principal investigator, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00467623
- Sponsor's protocol ID
- KA-93140
- Status last verified
- Apr 2007
- First submitted
- 27 Apr 2007
- Last updated
- 17 Oct 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Holotranscobalamin Remains Unchanged During Pregnancy. Longitudinal Changes of Cobalamins and Its Binding Proteins During Pregnancy and Postpartum
- ClinicalTrials.gov ID
- NCT00467623
- Acronym / sponsor ID
- KA-93140
- Conditions
- Vitamin B12 Deficiency
- Keywords
- Pregnancy, holotranscobalamin, cobalamin, vitamin B12 analogues, reference interval
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- University of Copenhagen
- Study start
- Jan 1995
- Study completion
- Dec 1997 (actual)
- First posted
- 30 Apr 2007 (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.
Background and objective: Plasma cobalamins decrease during pregnancy but it is not fully elucidated how this is reflected in the total and cobalamin saturated transport proteins, transcobalamin (total TC, holoTC) and haptocorrin (total HC, holoHC). TC transports cobalamin into the cells. The function of HC is unknown, but in contrast to TC it binds both cobalamins and cobalamin analogues.
Design and methods: Healthy pregnant women (N=141) had blood samples drawn at 18th, 32nd, 39th gestation week and 8 weeks postpartum. The protein moiety of TC and HC (total and holo) was measured by in-house ELISA methods.
Detailed description
Background and objective: Plasma cobalamins decrease during pregnancy but it is not fully elucidated how this is reflected in the total and cobalamin saturated transport proteins, transcobalamin (total TC, holoTC) and haptocorrin (total HC, holoHC). TC transports cobalamin into the cells. The function of HC is unknown, but in contrast to TC it binds both cobalamins and cobalamin analogues.
Design and methods: Healthy pregnant women (N=141) had blood samples drawn at 18th, 32nd, 39th gestation week and 8 weeks postpartum. The protein moiety of TC and HC (total and holo) was measured by in-house ELISA methods.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Danish healthy Caucasian women >18 years of age with previous uncomplicated pregnancies and deliveries and presently with a normal pregnancy.
Key exclusion criteria (3 listed)
- >4 cigarettes smoked per day,
- Treatment with vitamin B12, folic acid or acetyl salicylic acid,
- Impaired renal function and clinically significant vaginal haemorrhage before first visit as well as blood haemoglobin <6.4 mmol/L at first visit.
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
Not reported in the source record.
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 17 Oct 2008.
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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.
Nils Milman, MD principal investigator
University of Copenhagen
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 Vitamin B12 Deficiency, 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 1 inclusion and 3 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 17 Oct 2008. 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.
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 17 Oct 2008.