Micronutrient Status During Pregnancy

Deficiency Vitamins Clinical Trial

Official title:

Micronutrient Status in Pregnant and Lactating Women and Their Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03272022
• Other study ID #: 2011/2447
• Status: Completed
• Start date: December 14, 2011
• Est. completion date: February 8, 2016

Study information

• Verified date: February 2023
• Source: Haukeland University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 272
• Est. completion date: February 8, 2016
• Est. primary completion date: February 8, 2016
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• healthy never-pregnant and pregnant women

Exclusion Criteria:

chronic illness-

Related Conditions & MeSH terms

• Avitaminosis
• Deficiency Vitamins
• Vitamin A Deficiency

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Haukeland University Hospital

References & Publications (5)

Bjorke Monsen AL, Ueland PM, Vollset SE, Guttormsen AB, Markestad T, Solheim E, Refsum H. Determinants of cobalamin status in newborns. Pediatrics. 2001 Sep;108(3):624-30. doi: 10.1542/peds.108.3.624. Erratum In: Pediatrics 2002 Oct;110(4):853. — View Citation

Bjorke-Monsen AL, Torsvik I, Saetran H, Markestad T, Ueland PM. Common metabolic profile in infants indicating impaired cobalamin status responds to cobalamin supplementation. Pediatrics. 2008 Jul;122(1):83-91. doi: 10.1542/peds.2007-2716. — View Citation

Green R, Allen LH, Bjorke-Monsen AL, Brito A, Gueant JL, Miller JW, Molloy AM, Nexo E, Stabler S, Toh BH, Ueland PM, Yajnik C. Vitamin B12 deficiency. Nat Rev Dis Primers. 2017 Jun 29;3:17040. doi: 10.1038/nrdp.2017.40. Erratum In: Nat Rev Dis Primers. 20 — View Citation

Torsvik I, Ueland PM, Markestad T, Bjorke-Monsen AL. Cobalamin supplementation improves motor development and regurgitations in infants: results from a randomized intervention study. Am J Clin Nutr. 2013 Nov;98(5):1233-40. doi: 10.3945/ajcn.113.061549. Ep — View Citation

Torsvik IK, Ueland PM, Markestad T, Midttun O, Bjorke Monsen AL. Motor development related to duration of exclusive breastfeeding, B vitamin status and B12 supplementation in infants with a birth weight between 2000-3000 g, results from a randomized inter — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in micronutrient status during pregnancy and lactation	Determine adequate vitamin levels in pregnancy and lactation	The investigators will study change in micronutrients during pregnancy and lactation