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Clinical Trials/NCT03272022
NCT03272022
Completed
Not Applicable

Micronutrient Status in Pregnant and Lactating Women and Their Infants

Haukeland University Hospital0 sites272 target enrollmentDecember 14, 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Deficiency Vitamins
Sponsor
Haukeland University Hospital
Enrollment
272
Primary Endpoint
Change in micronutrient status during pregnancy and lactation
Status
Completed
Last Updated
3 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
December 14, 2011
End Date
February 8, 2016
Last Updated
3 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
Haukeland University Hospital
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • healthy never-pregnant and pregnant women

Exclusion Criteria

  • chronic illness-

Outcomes

Primary Outcomes

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

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