The Absorption of Vitamin B12 Among Healthy Pregnant Women | NCT00730093

Studies
The Absorption of Vitamin B12 Among Healthy Pregnant Women

NCT00730093

Sponsor

University of Aarhus

Status

Completed

Last Update Posted

Aug 6, 2009Estimated

Enrollment

27Actual

Phase

Not Applicable

Conditions

Pregnancy

Interventions

B12 vitamin (Cyanocobalamin)

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2008

Primary Completion Date

Jul 2009Actual

Completion Date

Aug 2009Actual

First Submitted Date

Jul 11, 2008

First Submission Date that Met QC Criteria

Aug 7, 2008

First Posted Date

Aug 8, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 5, 2009

Last Update Posted Date

Aug 6, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

27Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Other		Dietary Supplement: B12 vitamin (Cyanocobalamin)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
B12 vitamin (Cyanocobalamin)	Dietary Supplement	Arm A: B12 vitamin (Cyanocobalamin)	A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in vitamin B12 absorption during pregnancy, measured with CobaSorb.		9 month

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ebba Nexø, Professor	Aarhus Universitetshospital, Aarhus Sygehus	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Aarhus Universitetshospital, Skejby		Skejby	Jylland	8200	Denmark

Intervention Browse Module

MeSH Terms

ID	Term
D014805	Vitamin B 12

Ancestor Terms

ID	Term
D045728	Corrinoids
D045725	Tetrapyrroles
D011758	Pyrroles
D001393	Azoles
D006573

Browse Leaves

Not provided

Browse Branches

Not provided