<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03272022</url>
  </required_header>
  <id_info>
    <org_study_id>2011/2447</org_study_id>
    <nct_id>NCT03272022</nct_id>
  </id_info>
  <brief_title>Micronutrient Status During Pregnancy</brief_title>
  <official_title>Micronutrient Status in Pregnant and Lactating Women and Their Infants</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Haukeland University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Haukeland University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      An adequate micronutrient status during fetal life and infancy is important for optimal&#xD;
      development. Dietary practices during pregnancy, lactation and infancy vary among populations&#xD;
      and there is today no clear agreement on what constitutes the best diet, including&#xD;
      micronutrient supplementation, during this period. There is consequently no clear agreement&#xD;
      on what constitutes an optimal biochemical micronutrient status in mothers and infants. Due&#xD;
      to substantial physiological changes in plasma volume, hormones, transport proteins and organ&#xD;
      function during these periods, the ordinary reference levels or cut off levels used for&#xD;
      biochemical assessment of micronutrient status are unsuited to these groups of patients.&#xD;
&#xD;
      The objective of the study is to establish cut off levels for important vitamins and trace&#xD;
      elements during pregnancy, lactation and infancy in order to ensure an optimal infant&#xD;
      neurodevelopment and to study how micronutrient status influence the immunosystem.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators have analyzed micronutrients, including all vitamins and trace elements and&#xD;
      related aminoacids and markers of cellular immunoactivation in 160 fertile, unpregnant women,&#xD;
      115 pregnant women from pregnancy week 18, throughout pregnancy and the first 6 postpartum&#xD;
      months and their infant at 6 months. Infant gross motor development is associated with&#xD;
      micronutrient status, so the investigators will relate gross motor development at 6 months to&#xD;
      maternal micronutrient status during pregnancy and postpartum, in order to establish relevant&#xD;
      cut off levels for micronutrients and related biomarkers.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 14, 2011</start_date>
  <completion_date type="Actual">February 8, 2016</completion_date>
  <primary_completion_date type="Actual">February 8, 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change in micronutrient status during pregnancy and lactation</measure>
    <time_frame>The investigators will study change in micronutrients during pregnancy and lactation</time_frame>
    <description>Determine adequate vitamin levels in pregnancy and lactation</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">272</enrollment>
  <condition>Deficiency Vitamins</condition>
  <arm_group>
    <arm_group_label>women</arm_group_label>
    <description>never-pregnant women</description>
  </arm_group>
  <arm_group>
    <arm_group_label>pregnant women</arm_group_label>
    <description>pregnant</description>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Serum and plasma from never-pregnant, pregnant and lactating women and infants aged six&#xD;
      months&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        healthy never-pregnant (n =158) and pregnant women (n=114) and their infants (n=114)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  healthy never-pregnant and pregnant women&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        chronic illness-&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>pregnant women and never-pregnant women</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Gunnar Mellgren, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Haukeland University Hospital</affiliation>
  </overall_official>
  <results_reference>
    <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. 2017 Jul 20;3:17054.</citation>
    <PMID>28660890</PMID>
  </results_reference>
  <results_reference>
    <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 intervention trial. BMC Pediatr. 2015 Dec 18;15:218. doi: 10.1186/s12887-015-0533-2.</citation>
    <PMID>26678525</PMID>
  </results_reference>
  <results_reference>
    <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. Epub 2013 Sep 11.</citation>
    <PMID>24025626</PMID>
  </results_reference>
  <results_reference>
    <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.</citation>
    <PMID>18595990</PMID>
  </results_reference>
  <results_reference>
    <citation>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.</citation>
    <PMID>11533328</PMID>
  </results_reference>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>August 30, 2017</study_first_submitted>
  <study_first_submitted_qc>September 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 5, 2017</study_first_posted>
  <last_update_submitted>February 28, 2023</last_update_submitted>
  <last_update_submitted_qc>February 28, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 1, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>cobalamin, folate</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vitamin A Deficiency</mesh_term>
    <mesh_term>Avitaminosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03272022
org study id: 2011/2447
nct id: NCT03272022
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
observational model: Cohort
time perspective: Prospective
measure: Change in micronutrient status during pregnancy and lactation
time frame: The investigators will study change in micronutrients during pregnancy and lactation
description: Determine adequate vitamin levels in pregnancy and lactation
arm group label: women
description: never-pregnant women
arm group label: pregnant women
description: pregnant
Serum and plasma from never-pregnant, pregnant and lactating women and infants aged six
      months
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
gender based: Yes
gender description: pregnant women and never-pregnant women
minimum age: 18 Years
maximum age: 40 Years
last name: Gunnar Mellgren, MD, PhD
role: Study Director
affiliation: Haukeland University Hospital
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. 2017 Jul 20;3:17054.
PMID: 28660890
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 intervention trial. BMC Pediatr. 2015 Dec 18;15:218. doi: 10.1186/s12887-015-0533-2.
PMID: 26678525
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. Epub 2013 Sep 11.
PMID: 24025626
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.
PMID: 18595990
citation: 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.
PMID: 11533328
responsible party type: Sponsor
mesh term: Vitamin A Deficiency
mesh term: Avitaminosis
sharing ipd: Undecided