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Micronutrient Status During Pregnancy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03272022
Recruitment Status : Active, not recruiting
First Posted : September 5, 2017
Last Update Posted : August 25, 2021
Sponsor:
Information provided by (Responsible Party):
Haukeland University Hospital

Study Description
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Brief Summary:

An adequate micronutrient status during fetal life and infancy is important for optimal development. Dietary practices during pregnancy, lactation and infancy vary among populations and there is today no clear agreement on what constitutes the best diet, including micronutrient supplementation, during this period. There is consequently no clear agreement on what constitutes an optimal biochemical micronutrient status in mothers and infants. Due to substantial physiological changes in plasma volume, hormones, transport proteins and organ function during these periods, the ordinary reference levels or cut off levels used for biochemical assessment of micronutrient status are unsuited to these groups of patients.

The objective of the study is to establish cut off levels for important vitamins and trace elements during pregnancy, lactation and infancy in order to ensure an optimal infant neurodevelopment and to study how micronutrient status influence the immunosystem.


Condition or disease
Deficiency Vitamins

Detailed Description:
The investigators have analyzed micronutrients, including all vitamins and trace elements and related aminoacids and markers of cellular immunoactivation in 160 fertile, unpregnant women, 115 pregnant women from pregnancy week 18, throughout pregnancy and the first 6 postpartum months and their infant at 6 months. Infant gross motor development is associated with micronutrient status, so the investigators will relate gross motor development at 6 months to maternal micronutrient status during pregnancy and postpartum, in order to establish relevant cut off levels for micronutrients and related biomarkers.
Study Design
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Study Type : Observational
Actual Enrollment : 272 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Micronutrient Status in Pregnant and Lactating Women and Their Infants
Actual Study Start Date : December 14, 2011
Estimated Primary Completion Date : February 8, 2025
Estimated Study Completion Date : February 8, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pregnancy

Groups and Cohorts
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Group/Cohort
women
never-pregnant women
pregnant women
pregnant


Outcome Measures
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Primary Outcome Measures :
  1. Change in micronutrient status during pregnancy and lactation [ Time Frame: The investigators will study change in micronutrients during pregnancy and lactation ]
    Determine adequate vitamin levels in pregnancy and lactation


Biospecimen Retention:   Samples Without DNA
Serum and plasma from never-pregnant, pregnant and lactating women and infants aged six months

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   pregnant women and never-pregnant women
Sampling Method:   Non-Probability Sample
Study Population
healthy never-pregnant (n =158) and pregnant women (n=114) and their infants (n=114)
Criteria

Inclusion Criteria:

  • healthy never-pregnant and pregnant women

Exclusion Criteria:

chronic illness-

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03272022


Sponsors and Collaborators
Haukeland University Hospital
Investigators
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Study Director: Gunnar Mellgren, MD, PhD Haukeland University Hospital
More Information
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Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Haukeland University Hospital
ClinicalTrials.gov Identifier: NCT03272022    
Other Study ID Numbers: 2011/2447
First Posted: September 5, 2017    Key Record Dates
Last Update Posted: August 25, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Haukeland University Hospital:
cobalamin, folate
Additional relevant MeSH terms:
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Vitamin A Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders