NCT00730093

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. .

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable pregnancy

Timeline
Completed

Started Aug 2008

Shorter than P25 for not_applicable pregnancy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 11, 2008

Completed
21 days until next milestone

Study Start

First participant enrolled

August 1, 2008

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 8, 2008

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

August 6, 2009

Status Verified

August 1, 2009

Enrollment Period

11 months

First QC Date

July 11, 2008

Last Update Submit

August 5, 2009

Conditions

Pregnancy

Keywords

Vitamin B12 absorptionPregnancy

Outcome Measures

Primary Outcomes (1)

  • Change in vitamin B12 absorption during pregnancy, measured with CobaSorb.

    9 month

Study Arms (1)

A

OTHER
Dietary Supplement: B12 vitamin (Cyanocobalamin)

Interventions

B12 vitamin (Cyanocobalamin)DIETARY_SUPPLEMENT

Arm A: B12 vitamin (Cyanocobalamin)

A

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • the 13 week of gestation +/- 1 week (only fore pregnant women)
  • Between 20- 40 years
  • Northern European
  • abel to read and understand danish

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus Universitetshospital, Skejby

Skejby, Jylland, 8200, Denmark

Location

MeSH Terms

Interventions

Vitamin B 12

Intervention Hierarchy (Ancestors)

CorrinoidsTetrapyrrolesPyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingMacrocyclic CompoundsPolycyclic Compounds

Study Officials

  • Ebba Nexø, Professor

    Aarhus Universitetshospital, Aarhus Sygehus

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 11, 2008

First Posted

August 8, 2008

Study Start

August 1, 2008

Primary Completion

July 1, 2009

Study Completion

August 1, 2009

Last Updated

August 6, 2009

Record last verified: 2009-08

Locations

DK(1)