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NCT00730093 Clinical Trial

The Absorption of Vitamin B12 Among Healthy Pregnant Women

Pregnancy Clinical Trial

Official title:
The Absorption of Vitamin B12 Among Healthy Pregnant Women

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00730093
Other study ID # BH12008
Secondary ID
Status Completed
Phase N/A
First received July 11, 2008
Last updated August 5, 2009
Start date August 2008
Est. completion date August 2009

Study information
Verified date August 2009
Source University of Aarhus
Contact n/a
Is FDA regulated No
Health authority Denmark: Ethics CommitteeDenmark: Danish Dataprotection Agency
Study type Interventional

Clinical 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 27
Est. completion date August 2009
Est. primary completion date July 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 20 Years to 40 Years
Eligibility Inclusion Criteria:

- the 13 week of gestation +/- 1 week (only fore pregnant women)

- Between 20- 40 years

- Northern European

- abel to read and understand danish

Exclusion Criteria:

- 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• B12 vitamin (Cyanocobalamin)
Arm A: B12 vitamin (Cyanocobalamin)

Locations
Country Name City State
Denmark Aarhus Universitetshospital, Skejby Skejby Jylland

Sponsors (1)
Lead Sponsor Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in vitamin B12 absorption during pregnancy, measured with CobaSorb. 9 month No
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