NCT00467623

Brief Summary

Background and objective: Plasma cobalamins decrease during pregnancy but it is not fully elucidated how this is reflected in the total and cobalamin saturated transport proteins, transcobalamin (total TC, holoTC) and haptocorrin (total HC, holoHC). TC transports cobalamin into the cells. The function of HC is unknown, but in contrast to TC it binds both cobalamins and cobalamin analogues. Design and methods: Healthy pregnant women (N=141) had blood samples drawn at 18th, 32nd, 39th gestation week and 8 weeks postpartum. The protein moiety of TC and HC (total and holo) was measured by in-house ELISA methods.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 1995

Typical duration for all trials

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

Study Start

First participant enrolled

January 1, 1995

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 1997

Completed
9.4 years until next milestone

First Submitted

Initial submission to the registry

April 27, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 30, 2007

Completed
Last Updated

October 17, 2008

Status Verified

April 1, 2007

First QC Date

April 27, 2007

Last Update Submit

October 16, 2008

Conditions

Vitamin B12 Deficiency

Keywords

Pregnancyholotranscobalamincobalaminvitamin B12 analoguesreference interval

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Danish healthy Caucasian women \>18 years of age with previous uncomplicated pregnancies and deliveries and presently with a normal pregnancy.

You may not qualify if:

  • \>4 cigarettes smoked per day,
  • Treatment with vitamin B12, folic acid or acetyl salicylic acid,
  • Impaired renal function and clinically significant vaginal haemorrhage before first visit as well as blood haemoglobin \<6.4 mmol/L at first visit.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nils Milman

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Vitamin B 12 Deficiency

Condition Hierarchy (Ancestors)

Vitamin B DeficiencyAvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Nils Milman, MD

    University of Copenhagen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 27, 2007

First Posted

April 30, 2007

Study Start

January 1, 1995

Study Completion

December 1, 1997

Last Updated

October 17, 2008

Record last verified: 2007-04

Locations

DK(1)