The Absorption of Vitamin B12 Among Healthy Pregnant Women

This study has been completed.
Sponsor:
Information provided by:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00730093
First received: July 11, 2008
Last updated: August 5, 2009
Last verified: August 2009
  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.

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Condition Intervention
Pregnancy
Dietary Supplement: B12 vitamin (Cyanocobalamin)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   20 Years to 40 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: July 11, 2008
Last Updated: August 5, 2009
Health Authority: Denmark: Ethics Committee
Denmark: Danish Dataprotection Agency

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
Pharmacologic Actions
Hematinics
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014