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CompletedNCT03272022Updated Mar 1, 2023

Micronutrient Status During Pregnancy

An observational study in Deficiency Vitamins, sponsored by Haukeland University Hospital. Completed. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2023-03-01.

Sponsored by Haukeland University Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
272
Ages
18 Years to 40 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Deficiency Vitamins

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Keywords

  • cobalamin, folate
03

In context

Avitaminosis

35 studies on the registry are indexed under Avitaminosis; 3 are open to participants now.

This study's enrollment of 272 is below the median of 327 across 10 observational studies indexed under Avitaminosis.

Browse Avitaminosis studies →

Lead sponsor

Haukeland University Hospital is the lead sponsor of 284 studies on the registry; 59 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Sampling method
Non-probability sample

Study population

healthy never-pregnant (n =158) and pregnant women (n=114) and their infants (n=114)

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • healthy never-pregnant and pregnant women

Exclusion criteria

Exclusion Criteria:

chronic illness-

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
272 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • women

    never-pregnant women

  • pregnant women

    pregnant

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What researchers measure

Primary outcomes

  1. Change in micronutrient status during pregnancy and lactation

    Determine adequate vitamin levels in pregnancy and lactation

    Time frame: The investigators will study change in micronutrients during pregnancy and lactation

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • 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. 2017 Jul 20;3:17054. doi: 10.1038/nrdp.2017.54. PubMed 28660890 ↗
  • 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 intervention trial. BMC Pediatr. 2015 Dec 18;15:218. doi: 10.1186/s12887-015-0533-2. PubMed 26678525 ↗
  • 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. Epub 2013 Sep 11. PubMed 24025626 ↗
  • 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. PubMed 18595990 ↗
  • 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. PubMed 11533328 ↗
  • Bjorke-Monsen AL, Varsi K, Averina M, Brox J, Huber S. Perfluoroalkyl substances (PFASs) and mercury in never-pregnant women of fertile age: association with fish consumption and unfavorable lipid profile. BMJ Nutr Prev Health. 2020 Nov 4;3(2):277-284. doi: 10.1136/bmjnph-2020-000131. eCollection 2020 Dec. PubMed 33521539 ↗
  • Varsi K, Ueland PM, Torsvik IK, Bjorke-Monsen AL. Maternal Serum Cobalamin at 18 Weeks of Pregnancy Predicts Infant Cobalamin Status at 6 Months-A Prospective, Observational Study. J Nutr. 2018 May 1;148(5):738-745. doi: 10.1093/jn/nxy028. PubMed 29947806 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Dec 2011 to primary completion in Feb 2016, 49 months.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 30, 2017
First posted
Sep 5, 2017
StartActual
Dec 14, 2011
Primary completionActual
Feb 8, 2016
CompletionActual
Feb 8, 2016
Last update
Mar 1, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 1, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03272022
Responsible party
Sponsor
First posted
Sep 5, 2017
Start date
Dec 14, 2011
Primary completion
Feb 8, 2016
Completion
Feb 8, 2016
Last update
Mar 1, 2023

Study contacts

Gunnar Mellgren, MD, PhD
study director · Haukeland University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

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