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The Absorption of Vitamin B12 Among Healthy Pregnant Women

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00730093
First Posted: August 8, 2008
Last Update Posted: August 6, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Aarhus
  Purpose

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.


Condition Intervention
Pregnancy Dietary Supplement: B12 vitamin (Cyanocobalamin)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The Absorption of Vitamin B12 Among Healthy Pregnant Women

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Change in vitamin B12 absorption during pregnancy, measured with CobaSorb. [ Time Frame: 9 month ]

Enrollment: 27
Study Start Date: August 2008
Study Completion Date: August 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A Dietary Supplement: B12 vitamin (Cyanocobalamin)
Arm A: B12 vitamin (Cyanocobalamin)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00730093


Locations
Denmark
Aarhus Universitetshospital, Skejby
Skejby, Jylland, Denmark, 8200
Sponsors and Collaborators
University of Aarhus
Investigators
Study Chair: Ebba Nexø, Professor Aarhus Universitetshospital, Aarhus Sygehus
  More Information

Responsible Party: Professor, md, Ebba Nexø, Klinisk Biokemisk Afd., Århus Universitetshospital, Århus Sygehus,
ClinicalTrials.gov Identifier: NCT00730093     History of Changes
Other Study ID Numbers: BH12008
First Submitted: July 11, 2008
First Posted: August 8, 2008
Last Update Posted: August 6, 2009
Last Verified: August 2009

Keywords provided by University of Aarhus:
Vitamin B12 absorption
Pregnancy

Additional relevant MeSH terms:
Vitamins
Vitamin B 12
Hydroxocobalamin
Vitamin B Complex
Micronutrients
Growth Substances
Physiological Effects of Drugs
Hematinics