The Absorption of Vitamin B12 Among Healthy Pregnant Women
This study has been completed.
Sponsor:
University of Aarhus
Information provided by:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00730093
First received: July 11, 2008
Last updated: August 5, 2009
Last verified: August 2009
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | July 11, 2008 | ||||
| Last Updated Date | August 5, 2009 | ||||
| Start Date ICMJE | August 2008 | ||||
| Primary Completion Date | July 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Change in vitamin B12 absorption during pregnancy, measured with CobaSorb. [ Time Frame: 9 month ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00730093 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE |
Difference in vitamin B12 absorption, measured with CobaSorb, between pregnant healthy women and non-pregnant healthy women [ Time Frame: 6 month ] [ Designated as safety issue: No ] | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | The Absorption of Vitamin B12 Among Healthy Pregnant Women | ||||
| Official Title ICMJE | The Absorption of Vitamin B12 Among Healthy Pregnant Women | ||||
| 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. . |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Bio-availability Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Supportive Care |
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| Condition ICMJE | Pregnancy | ||||
| Intervention ICMJE | Dietary Supplement: B12 vitamin (Cyanocobalamin)
Arm A: B12 vitamin (Cyanocobalamin) |
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| Study Arm (s) | A
Intervention: Dietary Supplement: B12 vitamin (Cyanocobalamin) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 27 | ||||
| Completion Date | August 2009 | ||||
| Primary Completion Date | July 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | 20 Years to 40 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Denmark | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00730093 | ||||
| Other Study ID Numbers ICMJE | BH12008 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Professor, md, Ebba Nexø, Klinisk Biokemisk Afd., Århus Universitetshospital, Århus Sygehus, | ||||
| Study Sponsor ICMJE | University of Aarhus | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University of Aarhus | ||||
| Verification Date | August 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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