Trials / Completed
CompletedNCT03272022
Micronutrient Status During Pregnancy
Micronutrient Status in Pregnant and Lactating Women and Their Infants
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 272 (actual)
- Sponsor
- Haukeland University Hospital · Academic / Other
- Sex
- Female
- Age
- 18 Years – 40 Years
- Healthy volunteers
- —
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.
Conditions
Timeline
- Start date
- 2011-12-14
- Primary completion
- 2016-02-08
- Completion
- 2016-02-08
- First posted
- 2017-09-05
- Last updated
- 2023-03-01
Source: ClinicalTrials.gov record NCT03272022. Inclusion in this directory is not an endorsement.