Micronutrient Status During Pregnancy

Completed

• Conditions: Deficiency Vitamins

• Registration Number: NCT03272022
• Lead Sponsor: Haukeland University Hospital

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.

Study Timeline

• Study Start: 2011-12-14
• Primary Completion: 2016-02-08
• Study Completion: 2016-02-08
• Study First Submitted: 2017-08-30
• Study First Submitted QC: 2017-09-01
• Study First Posted: 2017-09-05
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-28
• Last Update Posted: 2023-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 272

Inclusion Criteria

• healthy never-pregnant and pregnant women

Exclusion Criteria

chronic illness-

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in micronutrient status during pregnancy and lactation	The investigators will study change in micronutrients during pregnancy and lactation	Determine adequate vitamin levels in pregnancy and lactation