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Holotranscobalamin Remains Unchanged During Pregnancy

This study has been completed.
Sponsor:
Collaborator:
University of Copenhagen
Information provided by:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00467623
First received: April 27, 2007
Last updated: October 16, 2008
Last verified: April 2007
History of Changes
  Purpose

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.


Condition
Vitamin B12 Deficiency

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Holotranscobalamin Remains Unchanged During Pregnancy. Longitudinal Changes of Cobalamins and Its Binding Proteins During Pregnancy and Postpartum

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Aarhus:

Estimated Enrollment: 150
Study Start Date: January 1995
Study Completion Date: December 1997
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • >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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00467623

Locations
Denmark
Nils Milman
Copenhagen, Denmark, 2100
Sponsors and Collaborators
University of Aarhus
University of Copenhagen
Investigators
Principal Investigator: Nils Milman, MD University of Copenhagen
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00467623     History of Changes
Other Study ID Numbers: KA-93140
Study First Received: April 27, 2007
Last Updated: October 16, 2008
Health Authority: Denmark: Ethics Committee

Keywords provided by University of Aarhus:
Pregnancy
holotranscobalamin
cobalamin
vitamin B12 analogues
reference interval

Additional relevant MeSH terms:
Vitamin B 12 Deficiency
Vitamin B Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamin B 12
 Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013