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OpenTrials
Completed

NCT Number: NCT03272022

Micronutrient Status During Pregnancy

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.

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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • healthy never-pregnant and pregnant women

Exclusion criteria

chronic illness-

Treatment and study plan

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Haukeland University Hospital

Other

Registry information

Official study title

Micronutrient Status in Pregnant and Lactating Women and Their Infants

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
Sep 5, 2017
Registry last updated
Mar 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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