xml: <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/NCT05973552</url>
    </required_header>
    <id_info>
      <org_study_id>PILLAR_II</org_study_id>
      <nct_id>NCT05973552</nct_id>
    </id_info>
    <brief_title>Iron Absorption and Requirements in Pregnancy and Lactation</brief_title>
    <acronym>PILLAR_II</acronym>
    <official_title>Assessment of Iron Absorption and Requirements During Pregnancy and Lactation in Kenyan Women</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Oxford</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Columbia University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Jomo Kenyatta University of Agriculture and Technology</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Msambweni County Referral Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>ETH Zurich</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Oxford</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>
        Iron requirements increase significantly during pregnancy. Current recommendations for iron&#xD;
        intake in pregnant and lactating women (PLW) are mainly based on factorial estimates and&#xD;
        extrapolated from non-PLW. High-quality quantitative data on iron requirements in PLW are&#xD;
        lacking, particularly in Sub- Saharan Africa where anaemia and infections are common.&#xD;
  &#xD;
        The primary objective of this study is to use the stable iron isotope technique to determine&#xD;
        iron requirements and assess iron absorption and losses in PLW living in Kenya.&#xD;
  &#xD;
        In this prospective observational study, we will enrol pregnant women in the first trimester&#xD;
        (n = 250) from a previous study cohort (n=1000) who participated in an iron absorption study&#xD;
        at least 12 months ago and received the stable iron (Fe) isotope 57Fe. This 57Fe has now&#xD;
        distributed and equilibrated throughout the women's body iron. Once enrolled in the present&#xD;
        study, following Kenyan guidelines, women will receive standard prenatal care, including&#xD;
        routine daily iron and folate supplementation. We will collect venous blood samples in each&#xD;
        trimester and at delivery, and during the first 6 months of lactation in the mothers and&#xD;
        infants (heel prick samples). To directly assess dietary iron absorption, in a randomly&#xD;
        selected subset of women (n=35), oral and intravenous stable iron isotope tracers (54Fe,&#xD;
        58Fe) will be administered in the 2nd and 3rd trimesters.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">July 31, 2023</start_date>
    <completion_date type="Anticipated">September 1, 2026</completion_date>
    <primary_completion_date type="Anticipated">June 30, 2026</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>Iron absorbed, lossed and gained in the first trimester</measure>
      <time_frame>Change in 57Fe tracer abundance between gestational age 6, 10 and 15 weeks</time_frame>
      <description>isotope dilution</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Iron absorbed, lossed and gained in the second trimester</measure>
      <time_frame>Change in 57Fe tracer abundance between gestational age 15, 20 and 25 weeks</time_frame>
      <description>isotope dilution</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Iron absorbed, lossed and gained in the third trimester</measure>
      <time_frame>Change in 57Fe tracer abundance between gestational age 25, 30 and 35 weeks</time_frame>
      <description>isotope dilution</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Iron absorbed, lossed and gained throughout pregnancy</measure>
      <time_frame>Change in 57Fe tracer abundance between gestational age 6, 10, 15, 20, 25, 30 and 35 weeks</time_frame>
      <description>isotope dilution</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Iron absorbed, lossed and gained in lactating women</measure>
      <time_frame>Change in 57Fe tracer abundance between 6, 14 and 24 weeks postpartum</time_frame>
      <description>isotope dilution</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Iron absorbed, lossed and gained in infancy</measure>
      <time_frame>Change in 57Fe tracer abundance between age 6, 14 and 24 weeks</time_frame>
      <description>isotope dilution</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Fractional iron absorption (%) in the second trimester</measure>
      <time_frame>gestational age 20 weeks</time_frame>
      <description>shift in iron isotopic ratios</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Fractional iron absorption (%) in the third trimester</measure>
      <time_frame>gestational age 30 weeks</time_frame>
      <description>shift in iron isotopic ratios</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Erythrocyte iron incorporation (%) in the second trimester</measure>
      <time_frame>gestational age 20 weeks</time_frame>
      <description>shift in iron isotopic ratios</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Erythrocyte iron incorporation (%) in the third trimester</measure>
      <time_frame>gestational age 30 weeks</time_frame>
      <description>shift in iron isotopic ratios</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hemoglobin concentration (g/dl)</measure>
      <time_frame>gestational age 6 weeks</time_frame>
      <description>Hb</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hemoglobin concentration (g/dl)</measure>
      <time_frame>gestational age 10 weeks</time_frame>
      <description>Hb</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hemoglobin concentration (g/dl)</measure>
      <time_frame>gestational age 15 weeks</time_frame>
      <description>Hb</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hemoglobin concentration (g/dl)</measure>
      <time_frame>gestational age 20 weeks</time_frame>
      <description>Hb</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hemoglobin concentration (g/dl)</measure>
      <time_frame>gestational age 25 weeks</time_frame>
      <description>Hb</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hemoglobin concentration (g/dl)</measure>
      <time_frame>gestational age 30 weeks</time_frame>
      <description>Hb</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hemoglobin concentration (g/dl)</measure>
      <time_frame>gestational age 36 weeks</time_frame>
      <description>Hb</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hemoglobin concentration (g/dl)</measure>
      <time_frame>6 weeks postpartum</time_frame>
      <description>mother</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hemoglobin concentration (g/dl)</measure>
      <time_frame>age 6 weeks</time_frame>
      <description>infant</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hemoglobin concentration (g/dl)</measure>
      <time_frame>14 weeks postpartum</time_frame>
      <description>mother</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hemoglobin concentration (g/dl)</measure>
      <time_frame>age 14 weeks</time_frame>
      <description>infant</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hemoglobin concentration (g/dl)</measure>
      <time_frame>24 weeks postpartum</time_frame>
      <description>mother</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hemoglobin concentration (g/dl)</measure>
      <time_frame>age 24 weeks</time_frame>
      <description>infant</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mean corpuscular volume (fl)</measure>
      <time_frame>gestational age 6 weeks</time_frame>
      <description>MCV</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mean corpuscular volume (fl)</measure>
      <time_frame>gestational age 10 weeks</time_frame>
      <description>MCV</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mean corpuscular volume (fl)</measure>
      <time_frame>gestational age 20 weeks</time_frame>
      <description>MCV</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mean corpuscular volume (fl)</measure>
      <time_frame>gestational age 30 weeks</time_frame>
      <description>MCV</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mean corpuscular volume (fl)</measure>
      <time_frame>6 weeks postpartum</time_frame>
      <description>mother</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mean corpuscular volume (fl)</measure>
      <time_frame>age 6 weeks</time_frame>
      <description>infant</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mean corpuscular volume (fl)</measure>
      <time_frame>14 weeks postpartum</time_frame>
      <description>mother</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mean corpuscular volume (fl)</measure>
      <time_frame>age 14 weeks</time_frame>
      <description>infant</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mean corpuscular volume (fl)</measure>
      <time_frame>24 weeks postpartum</time_frame>
      <description>mother</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mean corpuscular volume (fl)</measure>
      <time_frame>age 24 weeks</time_frame>
      <description>infant</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Erythropoietin concentration (mU/ml)</measure>
      <time_frame>gestational age 10 weeks</time_frame>
      <description>EPO</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Erythropoietin concentration (mU/ml)</measure>
      <time_frame>gestational age 20 weeks</time_frame>
      <description>EPO</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Erythropoietin concentration (mU/ml)</measure>
      <time_frame>gestational age 30 weeks</time_frame>
      <description>EPO</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Erythropoietin concentration (mU/ml)</measure>
      <time_frame>6 weeks postpartum</time_frame>
      <description>EPO</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Erythropoietin concentration (mU/ml)</measure>
      <time_frame>14 weeks postpartum</time_frame>
      <description>EPO</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Erythropoietin concentration (mU/ml)</measure>
      <time_frame>24 weeks postpartum</time_frame>
      <description>EPO</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Erythroferrone concentration (ng/ml)</measure>
      <time_frame>gestational age 10 weeks</time_frame>
      <description>ERFE</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Erythroferrone concentration (ng/ml)</measure>
      <time_frame>gestational age 20 weeks</time_frame>
      <description>ERFE</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Erythroferrone concentration (ng/ml)</measure>
      <time_frame>gestational age 30 weeks</time_frame>
      <description>ERFE</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Erythroferrone concentration (ng/ml)</measure>
      <time_frame>6 weeks postpartum</time_frame>
      <description>ERFE</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Erythroferrone concentration (ng/ml)</measure>
      <time_frame>14 weeks postpartum</time_frame>
      <description>ERFE</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Erythroferrone concentration (ng/ml)</measure>
      <time_frame>24 weeks postpartum</time_frame>
      <description>ERFE</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hepcidin concentration (ng/ml)</measure>
      <time_frame>gestational age 10 weeks</time_frame>
      <description>Hep</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hepcidin concentration (ng/ml)</measure>
      <time_frame>gestational age 20 weeks</time_frame>
      <description>Hep</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hepcidin concentration (ng/ml)</measure>
      <time_frame>gestational age 30 weeks</time_frame>
      <description>Hep</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hepcidin concentration (ng/ml)</measure>
      <time_frame>6 weeks postpartum</time_frame>
      <description>Hep</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hepcidin concentration (ng/ml)</measure>
      <time_frame>14 weeks postpartum</time_frame>
      <description>Hep</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hepcidin concentration (ng/ml)</measure>
      <time_frame>24 weeks postpartum</time_frame>
      <description>Hep</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Serum ferritin concentration (ug/l)</measure>
      <time_frame>gestational age 10 weeks</time_frame>
      <description>SF</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Serum ferritin concentration (ug/l)</measure>
      <time_frame>gestational age 20 weeks</time_frame>
      <description>SF</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Serum ferritin concentration (ug/l)</measure>
      <time_frame>gestational age 30 weeks</time_frame>
      <description>SF</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Serum ferritin concentration (ug/l)</measure>
      <time_frame>6 weeks postpartum</time_frame>
      <description>mother</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Serum ferritin concentration (ug/l)</measure>
      <time_frame>age 6 weeks</time_frame>
      <description>infant</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Serum ferritin concentration (ug/l)</measure>
      <time_frame>14 weeks postpartum</time_frame>
      <description>mother</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Serum ferritin concentration (ug/l)</measure>
      <time_frame>age 14 weeks</time_frame>
      <description>infant</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Serum ferritin concentration (ug/l)</measure>
      <time_frame>24 weeks postpartum</time_frame>
      <description>mother</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Serum ferritin concentration (ug/l)</measure>
      <time_frame>age 24 weeks</time_frame>
      <description>infant</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Soluble transferrin receptor concentration (ul/l)</measure>
      <time_frame>gestational age 10 weeks</time_frame>
      <description>sTfR</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Soluble transferrin receptor concentration (ul/l)</measure>
      <time_frame>gestational age 20 weeks</time_frame>
      <description>sTfR</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Soluble transferrin receptor concentration (ul/l)</measure>
      <time_frame>gestational age 30 weeks</time_frame>
      <description>sTfR</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Soluble transferrin receptor concentration (ul/l)</measure>
      <time_frame>6 weeks postpartum</time_frame>
      <description>mother</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Soluble transferrin receptor concentration (ul/l)</measure>
      <time_frame>age 6 weeks</time_frame>
      <description>infant</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Soluble transferrin receptor concentration (ul/l)</measure>
      <time_frame>14 weeks postpartum</time_frame>
      <description>mother</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Soluble transferrin receptor concentration (ul/l)</measure>
      <time_frame>age 14 weeks</time_frame>
      <description>infant</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Soluble transferrin receptor concentration (ul/l)</measure>
      <time_frame>24 weeks postpartum</time_frame>
      <description>mother</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Soluble transferrin receptor concentration (ul/l)</measure>
      <time_frame>age 24 weeks</time_frame>
      <description>infant</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>C-reactive protein concentration (mg/l)</measure>
      <time_frame>gestational age 10 weeks</time_frame>
      <description>CRP</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>C-reactive protein concentration (mg/l)</measure>
      <time_frame>gestational age 20 weeks</time_frame>
      <description>CRP</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>C-reactive protein concentration (mg/l)</measure>
      <time_frame>gestational age 30 weeks</time_frame>
      <description>CRP</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>C-reactive protein concentration (mg/l)</measure>
      <time_frame>6 weeks postpartum</time_frame>
      <description>mother</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>C-reactive protein concentration (mg/l)</measure>
      <time_frame>age 6 weeks</time_frame>
      <description>infant</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>C-reactive protein concentration (mg/l)</measure>
      <time_frame>14 weeks postpartum</time_frame>
      <description>mother</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>C-reactive protein concentration (mg/l)</measure>
      <time_frame>age 14 weeks</time_frame>
      <description>infant</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>C-reactive protein concentration (mg/l)</measure>
      <time_frame>24 weeks postpartum</time_frame>
      <description>mother</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>C-reactive protein concentration (mg/l)</measure>
      <time_frame>age 24 weeks</time_frame>
      <description>infant</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>alpha-glycoprotein concentration (mg/dl)</measure>
      <time_frame>gestational age 10 weeks</time_frame>
      <description>AGP</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>alpha-glycoprotein concentration (mg/dl)</measure>
      <time_frame>gestational age 20 weeks</time_frame>
      <description>AGP</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>alpha-glycoprotein concentration (mg/dl)</measure>
      <time_frame>gestational age 30 weeks</time_frame>
      <description>AGP</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>alpha-glycoprotein concentration (mg/dl)</measure>
      <time_frame>6 weeks postpartum</time_frame>
      <description>mother</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>alpha-glycoprotein concentration (mg/dl)</measure>
      <time_frame>age 6 weeks</time_frame>
      <description>infant</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>alpha-glycoprotein concentration (mg/dl)</measure>
      <time_frame>14 weeks postpartum</time_frame>
      <description>mother</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>alpha-glycoprotein concentration (mg/dl)</measure>
      <time_frame>age 14 weeks</time_frame>
      <description>infant</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>alpha-glycoprotein concentration (mg/dl)</measure>
      <time_frame>24 weeks postpartum</time_frame>
      <description>mother</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>alpha-glycoprotein concentration (mg/dl)</measure>
      <time_frame>age 24 weeks</time_frame>
      <description>infant</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Blood volume (l)</measure>
      <time_frame>gestational age 10 weeks</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Blood volume (l)</measure>
      <time_frame>gestational age 20 weeks</time_frame>
      <description>BV</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Blood volume (l)</measure>
      <time_frame>gestational age 30 weeks</time_frame>
      <description>BV</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Blood volume (l)</measure>
      <time_frame>6 weeks postpartum</time_frame>
      <description>BV</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Blood volume (l)</measure>
      <time_frame>14 weeks postpartum</time_frame>
      <description>BV</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Blood volume (l)</measure>
      <time_frame>24 weeks postpartum</time_frame>
      <description>BV</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Intestinal fatty acid binding protein</measure>
      <time_frame>gestational age 10 weeks</time_frame>
      <description>I-FABP</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Intestinal fatty acid binding protein</measure>
      <time_frame>gestational age 20 weeks</time_frame>
      <description>I-FABP</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Intestinal fatty acid binding protein</measure>
      <time_frame>gestational age 30 weeks</time_frame>
      <description>I-FABP</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Retinol binding protein</measure>
      <time_frame>gestational age 10 weeks</time_frame>
      <description>RBP</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Retinol binding protein</measure>
      <time_frame>gestational age 20 weeks</time_frame>
      <description>RBP</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Retinol binding protein</measure>
      <time_frame>gestational age 30 weeks</time_frame>
      <description>RBP</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>soluble CD14</measure>
      <time_frame>gestational age 10 weeks</time_frame>
      <description>sCD14</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>soluble CD14</measure>
      <time_frame>gestational age 20 weeks</time_frame>
      <description>sCD14</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>soluble CD14</measure>
      <time_frame>gestational age 30 weeks</time_frame>
      <description>sCD14</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Insulin-like growth factor 1</measure>
      <time_frame>gestational age 10 weeks</time_frame>
      <description>IGF-1</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Insulin-like growth factor 1</measure>
      <time_frame>gestational age 20 weeks</time_frame>
      <description>IGF-1</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Insulin-like growth factor 1</measure>
      <time_frame>gestational age 30 weeks</time_frame>
      <description>IGF-1</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Fibroblast growth factor 21</measure>
      <time_frame>gestational age 10 weeks</time_frame>
      <description>FGF21</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Fibroblast growth factor 21</measure>
      <time_frame>gestational age 20 weeks</time_frame>
      <description>FGF21</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Fibroblast growth factor 21</measure>
      <time_frame>gestational age 30 weeks</time_frame>
      <description>FGF21</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">250</enrollment>
    <condition>Iron Requirements</condition>
    <condition>Pregnancy</condition>
    <condition>Lactation</condition>
    <condition>Infancy</condition>
    <condition>Iron Absorption</condition>
    <arm_group>
      <arm_group_label>All participants</arm_group_label>
      <description>Women (n=250), are followed throughout their pregnancy. Mother-infant pairs are followed throughout the first 6-months postpartum. Women receive daily oral iron supplementation during pregnancy in accordance with local standards of care. Using the stable iron isotopes dilution methodology, concentration of the stable iron isotope tracer (57Fe) in circulation will be measured throughout pregnancy and up to 6 months postpartum in both, mother and infant.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Randomly selected sub-group</arm_group_label>
      <description>To directly assess dietary iron absorption, in a randomly selected subset of women (n=35), oral and intravenous stable iron isotope tracers (54Fe, 58Fe) will be administered. Oral iron absorption and erythrocyte iron incorporation will be measured 14 days after tracer administration.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>CO-rebreathing</intervention_name>
      <description>In the CO-rebreathing method, a dedicated apparatus is used for inhaling and rebreathing a very small bolus of CO through a spirometer for ~2 min, which is absorbed through the lungs and binds to Hb, and then the increase of HbCO content of blood is measured 8 min after the CO inhalation. The increase of COHb in blood samples can then be used to precisely calculate Hb mass and blood volume</description>
      <arm_group_label>All participants</arm_group_label>
      <arm_group_label>Randomly selected sub-group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Oral iron isotope administration (54Fe)</intervention_name>
      <description>Participants randomly assigned to the sub-group, will receive 54Fe with a test meal in the second and third trimester for assessment of dietary iron absorption</description>
      <arm_group_label>Randomly selected sub-group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Intravenous iron isotope administration (58Fe)</intervention_name>
      <description>Participants randomly assigned to the sub-group, will receive intravenous 58Fe in the second and third trimester for assessment of erythrocyte iron incorporation</description>
      <arm_group_label>Randomly selected sub-group</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          This study will recruit 250 pregnant women in the first trimester who previously&#xD;
          participated in a stable iron isotope study (Clinical Trial ID: NCT05266703) and received&#xD;
          15 mg of the stable iron isotope 57Fe as an oral dose of ferrous sulphate at least 12&#xD;
          months before being enrolled in this trial.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Providing consent to the informed consent form&#xD;
  &#xD;
            -  Participation in a previous stable isotope absorption study and having received an&#xD;
               oral dose of 15 mg 57Fe at least 12 months prior to the date of inclusion in the study&#xD;
  &#xD;
            -  Positive pregnancy test and gestational age &lt;10 weeks based on history of last&#xD;
               menstrual period&#xD;
  &#xD;
            -  Permanent residence in the study area, and not expected to leave the study site for&#xD;
               more than 4 weeks over the following 16 months&#xD;
  &#xD;
            -  Assessment of good health by professional staff at Msambweni Hospital&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Pre-pregnancy body mass index &gt;30 kg/m2&#xD;
  &#xD;
            -  Blood transfusion or intravenous iron treatment within 4 months of study start&#xD;
  &#xD;
            -  Major chronic infectious disease (e.g., tuberculosis, HIV+, hepatitis)&#xD;
  &#xD;
            -  Major chronic non-infectious disease (e.g., Type 1 or 2 diabetes, cancer)&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>45 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Nicole Stoffel, PhD</last_name>
      <phone>+41446328393</phone>
      <email>nicole.stoffel@rdm.ox.ac.uk</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Joyce Wali, BSc</last_name>
      <phone>+254704862877</phone>
      <email>stellawali507@gmail.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Msambweni Referral Hospital</name>
        <address>
          <city>Msambweni</city>
          <country>Kenya</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Edith Mwasi, MD</last_name>
      </contact>
    </location>
    <location_countries>
      <country>Kenya</country>
    </location_countries>
    <verification_date>June 2023</verification_date>
    <study_first_submitted>July 18, 2023</study_first_submitted>
    <study_first_submitted_qc>July 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 3, 2023</study_first_posted>
    <last_update_submitted>July 31, 2023</last_update_submitted>
    <last_update_submitted_qc>July 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 3, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Iron</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05973552
  org study id: PILLAR_II
  nct id: NCT05973552
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Iron requirements increase significantly during pregnancy. Current recommendations for iron
        intake in pregnant and lactating women (PLW) are mainly based on factorial estimates and
        extrapolated from non-PLW. High-quality quantitative data on iron requirements in PLW are
        lacking, particularly in Sub- Saharan Africa where anaemia and infections are common.
  
        The primary objective of this study is to use the stable iron isotope technique to determine
        iron requirements and assess iron absorption and losses in PLW living in Kenya.
  
        In this prospective observational study, we will enrol pregnant women in the first trimester
        (n = 250) from a previous study cohort (n=1000) who participated in an iron absorption study
        at least 12 months ago and received the stable iron (Fe) isotope 57Fe. This 57Fe has now
        distributed and equilibrated throughout the women's body iron. Once enrolled in the present
        study, following Kenyan guidelines, women will receive standard prenatal care, including
        routine daily iron and folate supplementation. We will collect venous blood samples in each
        trimester and at delivery, and during the first 6 months of lactation in the mothers and
        infants (heel prick samples). To directly assess dietary iron absorption, in a randomly
        selected subset of women (n=35), oral and intravenous stable iron isotope tracers (54Fe,
        58Fe) will be administered in the 2nd and 3rd trimesters.
  observational model: Cohort
  time perspective: Prospective
  measure: Iron absorbed, lossed and gained in the first trimester
  time frame: Change in 57Fe tracer abundance between gestational age 6, 10 and 15 weeks
  description: isotope dilution
  measure: Iron absorbed, lossed and gained in the second trimester
  time frame: Change in 57Fe tracer abundance between gestational age 15, 20 and 25 weeks
  description: isotope dilution
  measure: Iron absorbed, lossed and gained in the third trimester
  time frame: Change in 57Fe tracer abundance between gestational age 25, 30 and 35 weeks
  description: isotope dilution
  measure: Iron absorbed, lossed and gained throughout pregnancy
  time frame: Change in 57Fe tracer abundance between gestational age 6, 10, 15, 20, 25, 30 and 35 weeks
  description: isotope dilution
  measure: Iron absorbed, lossed and gained in lactating women
  time frame: Change in 57Fe tracer abundance between 6, 14 and 24 weeks postpartum
  description: isotope dilution
  measure: Iron absorbed, lossed and gained in infancy
  time frame: Change in 57Fe tracer abundance between age 6, 14 and 24 weeks
  description: isotope dilution
  measure: Fractional iron absorption (%) in the second trimester
  time frame: gestational age 20 weeks
  description: shift in iron isotopic ratios
  measure: Fractional iron absorption (%) in the third trimester
  time frame: gestational age 30 weeks
  description: shift in iron isotopic ratios
  measure: Erythrocyte iron incorporation (%) in the second trimester
  time frame: gestational age 20 weeks
  description: shift in iron isotopic ratios
  measure: Erythrocyte iron incorporation (%) in the third trimester
  time frame: gestational age 30 weeks
  description: shift in iron isotopic ratios
  measure: Hemoglobin concentration (g/dl)
  time frame: gestational age 6 weeks
  description: Hb
  measure: Hemoglobin concentration (g/dl)
  time frame: gestational age 10 weeks
  description: Hb
  measure: Hemoglobin concentration (g/dl)
  time frame: gestational age 15 weeks
  description: Hb
  measure: Hemoglobin concentration (g/dl)
  time frame: gestational age 20 weeks
  description: Hb
  measure: Hemoglobin concentration (g/dl)
  time frame: gestational age 25 weeks
  description: Hb
  measure: Hemoglobin concentration (g/dl)
  time frame: gestational age 30 weeks
  description: Hb
  measure: Hemoglobin concentration (g/dl)
  time frame: gestational age 36 weeks
  description: Hb
  measure: Hemoglobin concentration (g/dl)
  time frame: 6 weeks postpartum
  description: mother
  measure: Hemoglobin concentration (g/dl)
  time frame: age 6 weeks
  description: infant
  measure: Hemoglobin concentration (g/dl)
  time frame: 14 weeks postpartum
  description: mother
  measure: Hemoglobin concentration (g/dl)
  time frame: age 14 weeks
  description: infant
  measure: Hemoglobin concentration (g/dl)
  time frame: 24 weeks postpartum
  description: mother
  measure: Hemoglobin concentration (g/dl)
  time frame: age 24 weeks
  description: infant
  measure: Mean corpuscular volume (fl)
  time frame: gestational age 6 weeks
  description: MCV
  measure: Mean corpuscular volume (fl)
  time frame: gestational age 10 weeks
  description: MCV
  measure: Mean corpuscular volume (fl)
  time frame: gestational age 20 weeks
  description: MCV
  measure: Mean corpuscular volume (fl)
  time frame: gestational age 30 weeks
  description: MCV
  measure: Mean corpuscular volume (fl)
  time frame: 6 weeks postpartum
  description: mother
  measure: Mean corpuscular volume (fl)
  time frame: age 6 weeks
  description: infant
  measure: Mean corpuscular volume (fl)
  time frame: 14 weeks postpartum
  description: mother
  measure: Mean corpuscular volume (fl)
  time frame: age 14 weeks
  description: infant
  measure: Mean corpuscular volume (fl)
  time frame: 24 weeks postpartum
  description: mother
  measure: Mean corpuscular volume (fl)
  time frame: age 24 weeks
  description: infant
  measure: Erythropoietin concentration (mU/ml)
  time frame: gestational age 10 weeks
  description: EPO
  measure: Erythropoietin concentration (mU/ml)
  time frame: gestational age 20 weeks
  description: EPO
  measure: Erythropoietin concentration (mU/ml)
  time frame: gestational age 30 weeks
  description: EPO
  measure: Erythropoietin concentration (mU/ml)
  time frame: 6 weeks postpartum
  description: EPO
  measure: Erythropoietin concentration (mU/ml)
  time frame: 14 weeks postpartum
  description: EPO
  measure: Erythropoietin concentration (mU/ml)
  time frame: 24 weeks postpartum
  description: EPO
  measure: Erythroferrone concentration (ng/ml)
  time frame: gestational age 10 weeks
  description: ERFE
  measure: Erythroferrone concentration (ng/ml)
  time frame: gestational age 20 weeks
  description: ERFE
  measure: Erythroferrone concentration (ng/ml)
  time frame: gestational age 30 weeks
  description: ERFE
  measure: Erythroferrone concentration (ng/ml)
  time frame: 6 weeks postpartum
  description: ERFE
  measure: Erythroferrone concentration (ng/ml)
  time frame: 14 weeks postpartum
  description: ERFE
  measure: Erythroferrone concentration (ng/ml)
  time frame: 24 weeks postpartum
  description: ERFE
  measure: Hepcidin concentration (ng/ml)
  time frame: gestational age 10 weeks
  description: Hep
  measure: Hepcidin concentration (ng/ml)
  time frame: gestational age 20 weeks
  description: Hep
  measure: Hepcidin concentration (ng/ml)
  time frame: gestational age 30 weeks
  description: Hep
  measure: Hepcidin concentration (ng/ml)
  time frame: 6 weeks postpartum
  description: Hep
  measure: Hepcidin concentration (ng/ml)
  time frame: 14 weeks postpartum
  description: Hep
  measure: Hepcidin concentration (ng/ml)
  time frame: 24 weeks postpartum
  description: Hep
  measure: Serum ferritin concentration (ug/l)
  time frame: gestational age 10 weeks
  description: SF
  measure: Serum ferritin concentration (ug/l)
  time frame: gestational age 20 weeks
  description: SF
  measure: Serum ferritin concentration (ug/l)
  time frame: gestational age 30 weeks
  description: SF
  measure: Serum ferritin concentration (ug/l)
  time frame: 6 weeks postpartum
  description: mother
  measure: Serum ferritin concentration (ug/l)
  time frame: age 6 weeks
  description: infant
  measure: Serum ferritin concentration (ug/l)
  time frame: 14 weeks postpartum
  description: mother
  measure: Serum ferritin concentration (ug/l)
  time frame: age 14 weeks
  description: infant
  measure: Serum ferritin concentration (ug/l)
  time frame: 24 weeks postpartum
  description: mother
  measure: Serum ferritin concentration (ug/l)
  time frame: age 24 weeks
  description: infant
  measure: Soluble transferrin receptor concentration (ul/l)
  time frame: gestational age 10 weeks
  description: sTfR
  measure: Soluble transferrin receptor concentration (ul/l)
  time frame: gestational age 20 weeks
  description: sTfR
  measure: Soluble transferrin receptor concentration (ul/l)
  time frame: gestational age 30 weeks
  description: sTfR
  measure: Soluble transferrin receptor concentration (ul/l)
  time frame: 6 weeks postpartum
  description: mother
  measure: Soluble transferrin receptor concentration (ul/l)
  time frame: age 6 weeks
  description: infant
  measure: Soluble transferrin receptor concentration (ul/l)
  time frame: 14 weeks postpartum
  description: mother
  measure: Soluble transferrin receptor concentration (ul/l)
  time frame: age 14 weeks
  description: infant
  measure: Soluble transferrin receptor concentration (ul/l)
  time frame: 24 weeks postpartum
  description: mother
  measure: Soluble transferrin receptor concentration (ul/l)
  time frame: age 24 weeks
  description: infant
  measure: C-reactive protein concentration (mg/l)
  time frame: gestational age 10 weeks
  description: CRP
  measure: C-reactive protein concentration (mg/l)
  time frame: gestational age 20 weeks
  description: CRP
  measure: C-reactive protein concentration (mg/l)
  time frame: gestational age 30 weeks
  description: CRP
  measure: C-reactive protein concentration (mg/l)
  time frame: 6 weeks postpartum
  description: mother
  measure: C-reactive protein concentration (mg/l)
  time frame: age 6 weeks
  description: infant
  measure: C-reactive protein concentration (mg/l)
  time frame: 14 weeks postpartum
  description: mother
  measure: C-reactive protein concentration (mg/l)
  time frame: age 14 weeks
  description: infant
  measure: C-reactive protein concentration (mg/l)
  time frame: 24 weeks postpartum
  description: mother
  measure: C-reactive protein concentration (mg/l)
  time frame: age 24 weeks
  description: infant
  measure: alpha-glycoprotein concentration (mg/dl)
  time frame: gestational age 10 weeks
  description: AGP
  measure: alpha-glycoprotein concentration (mg/dl)
  time frame: gestational age 20 weeks
  description: AGP
  measure: alpha-glycoprotein concentration (mg/dl)
  time frame: gestational age 30 weeks
  description: AGP
  measure: alpha-glycoprotein concentration (mg/dl)
  time frame: 6 weeks postpartum
  description: mother
  measure: alpha-glycoprotein concentration (mg/dl)
  time frame: age 6 weeks
  description: infant
  measure: alpha-glycoprotein concentration (mg/dl)
  time frame: 14 weeks postpartum
  description: mother
  measure: alpha-glycoprotein concentration (mg/dl)
  time frame: age 14 weeks
  description: infant
  measure: alpha-glycoprotein concentration (mg/dl)
  time frame: 24 weeks postpartum
  description: mother
  measure: alpha-glycoprotein concentration (mg/dl)
  time frame: age 24 weeks
  description: infant
  measure: Blood volume (l)
  time frame: gestational age 10 weeks
  measure: Blood volume (l)
  time frame: gestational age 20 weeks
  description: BV
  measure: Blood volume (l)
  time frame: gestational age 30 weeks
  description: BV
  measure: Blood volume (l)
  time frame: 6 weeks postpartum
  description: BV
  measure: Blood volume (l)
  time frame: 14 weeks postpartum
  description: BV
  measure: Blood volume (l)
  time frame: 24 weeks postpartum
  description: BV
  measure: Intestinal fatty acid binding protein
  time frame: gestational age 10 weeks
  description: I-FABP
  measure: Intestinal fatty acid binding protein
  time frame: gestational age 20 weeks
  description: I-FABP
  measure: Intestinal fatty acid binding protein
  time frame: gestational age 30 weeks
  description: I-FABP
  measure: Retinol binding protein
  time frame: gestational age 10 weeks
  description: RBP
  measure: Retinol binding protein
  time frame: gestational age 20 weeks
  description: RBP
  measure: Retinol binding protein
  time frame: gestational age 30 weeks
  description: RBP
  measure: soluble CD14
  time frame: gestational age 10 weeks
  description: sCD14
  measure: soluble CD14
  time frame: gestational age 20 weeks
  description: sCD14
  measure: soluble CD14
  time frame: gestational age 30 weeks
  description: sCD14
  measure: Insulin-like growth factor 1
  time frame: gestational age 10 weeks
  description: IGF-1
  measure: Insulin-like growth factor 1
  time frame: gestational age 20 weeks
  description: IGF-1
  measure: Insulin-like growth factor 1
  time frame: gestational age 30 weeks
  description: IGF-1
  measure: Fibroblast growth factor 21
  time frame: gestational age 10 weeks
  description: FGF21
  measure: Fibroblast growth factor 21
  time frame: gestational age 20 weeks
  description: FGF21
  measure: Fibroblast growth factor 21
  time frame: gestational age 30 weeks
  description: FGF21
  arm group label: All participants
  description: Women (n=250), are followed throughout their pregnancy. Mother-infant pairs are followed throughout the first 6-months postpartum. Women receive daily oral iron supplementation during pregnancy in accordance with local standards of care. Using the stable iron isotopes dilution methodology, concentration of the stable iron isotope tracer (57Fe) in circulation will be measured throughout pregnancy and up to 6 months postpartum in both, mother and infant.
  arm group label: Randomly selected sub-group
  description: To directly assess dietary iron absorption, in a randomly selected subset of women (n=35), oral and intravenous stable iron isotope tracers (54Fe, 58Fe) will be administered. Oral iron absorption and erythrocyte iron incorporation will be measured 14 days after tracer administration.
  intervention type: Other
  intervention name: CO-rebreathing
  description: In the CO-rebreathing method, a dedicated apparatus is used for inhaling and rebreathing a very small bolus of CO through a spirometer for ~2 min, which is absorbed through the lungs and binds to Hb, and then the increase of HbCO content of blood is measured 8 min after the CO inhalation. The increase of COHb in blood samples can then be used to precisely calculate Hb mass and blood volume
  arm group label: All participants
  arm group label: Randomly selected sub-group
  intervention type: Other
  intervention name: Oral iron isotope administration (54Fe)
  description: Participants randomly assigned to the sub-group, will receive 54Fe with a test meal in the second and third trimester for assessment of dietary iron absorption
  arm group label: Randomly selected sub-group
  intervention type: Other
  intervention name: Intravenous iron isotope administration (58Fe)
  description: Participants randomly assigned to the sub-group, will receive intravenous 58Fe in the second and third trimester for assessment of erythrocyte iron incorporation
  arm group label: Randomly selected sub-group
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: 45 Years
  healthy volunteers: No
  last name: Nicole Stoffel, PhD
  phone: +41446328393
  email: nicole.stoffel@rdm.ox.ac.uk
  last name: Joyce Wali, BSc
  phone: +254704862877
  email: stellawali507@gmail.com
  facility: 
  status: Recruiting
  contact: 
  country: Kenya
  responsible party type: Sponsor
  mesh term: Iron
  sharing ipd: No