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The Absorption of Vitamin B12 Among Healthy Pregnant Women

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ClinicalTrials.gov Identifier: NCT00730093
Recruitment Status : Completed
First Posted : August 8, 2008
Last Update Posted : August 6, 2009
Sponsor:
Information provided by:
University of Aarhus

Brief 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.


Condition or disease Intervention/treatment
Pregnancy Dietary Supplement: B12 vitamin (Cyanocobalamin)

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
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
Study Start Date : August 2008
Primary Completion Date : July 2009
Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: B Vitamins
U.S. FDA Resources

Arm Intervention/treatment
A Dietary Supplement: B12 vitamin (Cyanocobalamin)
Arm A: B12 vitamin (Cyanocobalamin)



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


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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

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

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 Posted: August 8, 2008    Key Record Dates
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