<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/NCT02203890</url>
  </required_header>
  <id_info>
    <org_study_id>CeSSIAM_02</org_study_id>
    <nct_id>NCT02203890</nct_id>
  </id_info>
  <brief_title>Normative State and Variation in Growth, Hematology, Hydration, Oxidation, Infection, Inflammation, Guatemalan Children</brief_title>
  <official_title>Study on the Normative State and Inter- and Intra-individual Variation in Growth, Hematology, Hydration and Markers of Oxidation, Infection and Inflammation in Preschool Children With a Similar Dietary Intake</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>María José Soto</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Universidad de Granada</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Center for Studies of Sensory Impairment, Aging and Metabolism</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will provide the researchers with an opportunity for the investigation of the&#xD;
      biomarkers and different human biology component variable interactions in children;&#xD;
      information that can generate new correlations between markers not known at the moment.&#xD;
&#xD;
      Regarding their analysis, variation could have multiple connotations. A categorical that&#xD;
      refers to a specific state, established with a diagnostic standard. And a numerical,&#xD;
      referring to a range or the absolute value limits in a continuous spectrum; this research&#xD;
      will allow us to express variability in the distance amplitude of the obtained values level,&#xD;
      as well as classifications or categories previously established in the possible cases.&#xD;
&#xD;
      OBJECTIVES PRINCIPAL OBJECTIVE&#xD;
&#xD;
      To estimate the inter and intra-individual variety in a selected series or biological&#xD;
      variables determinant of growth, body composition, infection, oxidation, inflammation and&#xD;
      hydration, in preschool children sharing the same institutional-based diet.&#xD;
&#xD;
      SPECIFIC OBJECTIVES&#xD;
&#xD;
        -  To determine the inter and intra-individual variation of growth in preschool children,&#xD;
           with a similar diet, who attend Secretariat of Beneficial Works of the First Lady system&#xD;
           daycare centers and to compare between semi-urban and rural.&#xD;
&#xD;
        -  To describe the inter-individual variation of the red blood cells circulating mass in&#xD;
           preschool children, with a similar diet, who attend day care centers and to compare&#xD;
           between semi-urban and rural.&#xD;
&#xD;
        -  To determine the inter-individual variation of systemic and intraintestinal oxidation in&#xD;
           preschool children, with a similar diet, who attend daycare centers and to compare&#xD;
           between semi-urban and rural.&#xD;
&#xD;
        -  To describe the inter-individual variation of systemic and intraintestinal inflammation&#xD;
           in preschool children, with a similar diet, who attend daycare centers and to compare&#xD;
           between semi-urban and rural.&#xD;
&#xD;
        -  To determine the inter and/or intra-individual variation of urinary tract infection and&#xD;
           gastrointestinal parasite infestation in preschool children, with a similar diet, who&#xD;
           attend daycare centers and to compare between semi-urban and rural.&#xD;
&#xD;
        -  To describe the inter and intra-individual variation of the hydration status in&#xD;
           preschool children, with a similar diet, who attend daycare centers and to compare&#xD;
           between semi-urban and rural.&#xD;
&#xD;
        -  To explore intra-individual associations in variables of the same research component or&#xD;
           different component variables.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Please note protocol is also available in Spanish.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2012</start_date>
  <completion_date type="Actual">November 2012</completion_date>
  <primary_completion_date type="Actual">November 2012</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Weight</measure>
    <time_frame>7th week of observation</time_frame>
    <description>Growth, measured trough weight (kg)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Hemoglobin</measure>
    <time_frame>8th week of observation</time_frame>
    <description>Hemoglobin (mg/dl) measured in Biochemistry Laboratory in La Democracia Hospital, Quetzaltenango, Guatemala.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Urine Osmolality-1</measure>
    <time_frame>6th week of observation</time_frame>
    <description>Hydration Status= measured in 24-h urine through urine volume and osmolality in osmometer Model Löser 815. Results in mOsm/kg.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Height</measure>
    <time_frame>7th week of observation</time_frame>
    <description>Growth, measured trough height (cm).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Urine Osmolality-2</measure>
    <time_frame>7th week of observation</time_frame>
    <description>Hydration Status= measured in 24-h urine through urine volume and osmolality Osmometer Model Löser 815. Results in mOsm/kg.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Urine Osmolality-3</measure>
    <time_frame>8th week of observation</time_frame>
    <description>Hydration Status= measured in 24-h urine through urine volume and osmolality in two different osmometers (Löser 815 and Osmomat 030). Results in mOsm/kg.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Urine Urea</measure>
    <time_frame>8th week of oservation</time_frame>
    <description>Urine solutes measured by the Scientific Instrumentation Center from the Granada University, Spain:&#xD;
urea (mg/l)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Urine Uric Acid</measure>
    <time_frame>8th week of oservation</time_frame>
    <description>Urine solutes measured by the Scientific Instrumentation Center from the Granada University, Spain:&#xD;
uric acid (mg/l)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Urine Sodium</measure>
    <time_frame>8th week of oservation</time_frame>
    <description>Urine solutes measured by the Scientific Instrumentation Center from the Granada University, Spain:&#xD;
sodium (mg/l)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Urine Potassium</measure>
    <time_frame>8th week of oservation</time_frame>
    <description>Urine solutes measured by the Scientific Instrumentation Center from the Granada University, Spain:&#xD;
potassium (mg/l)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Urine Calcium</measure>
    <time_frame>8th week of oservation</time_frame>
    <description>Urine solutes measured by the Scientific Instrumentation Center from the Granada University, Spain:&#xD;
calcium (mg/l)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Urine Magnesium</measure>
    <time_frame>8th week of oservation</time_frame>
    <description>Urine solutes measured by the Scientific Instrumentation Center from the Granada University, Spain:&#xD;
magnesium (mg/l)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Urine Phosphorus</measure>
    <time_frame>8th week of oservation</time_frame>
    <description>Urine solutes measured by the Scientific Instrumentation Center from the Granada University, Spain:&#xD;
inorganic phosphorus (mg/l)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Urine 15-f2t-Isoprostanes</measure>
    <time_frame>8th week of observation</time_frame>
    <description>Urine Oxidation biomarkers:&#xD;
15-f2t-Isoprostanes (ng/mL) Measured at the Institute of Nutrition and Food Technology, Center of Biomedical Research, University of Granada using ELISA assay kit (Oxford Biomedical Research, Inc., Catalog # EA84.102606, Michigan, USA)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Urine 8-Hydroxydeoxyguanosine</measure>
    <time_frame>8th week of observation</time_frame>
    <description>Urine Oxidation biomarkers:&#xD;
8-Hydroxydeoxyguanosine (ng/mL) Measured at the Institute of Nutrition and Food Technology, Center of Biomedical Research, University of Granada using ELISA assay kits (JaICA, Nikken SEIL Co., Ltd, Catalog# IM-KOGHS 040914E, Shizouka, Japan).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Catalase Activity</measure>
    <time_frame>8th week of observation</time_frame>
    <description>Activity of antioxidant enzymes in red blood cells; measured at the Institute of Nutrition and Food Technology, Center of Biomedical Research, University of Granada, using ELISA system:&#xD;
Catalase Activity (nmol/seg/g Hb)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Superoxide Dismutase Activity</measure>
    <time_frame>8th week of observation</time_frame>
    <description>Activity of antioxidant enzymes in red blood cells; measured at the Institute of Nutrition and Food Technology, Center of Biomedical Research, University of Granada, using ELISA system Superoxide Dismutase Activity (U/g Hb)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Gluthathione Reductase</measure>
    <time_frame>8th week of observation</time_frame>
    <description>Activity of antioxidant enzymes in red blood cells; measured at the Institute of Nutrition and Food Technology, Center of Biomedical Research, University of Granada, using ELISA system Gluthathione Reductase Activity (umol/min/g Hb)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Gluthathione Peroxidase</measure>
    <time_frame>8th week of observation</time_frame>
    <description>Activity of antioxidant enzymes in red blood cells; measured at the Institute of Nutrition and Food Technology, Center of Biomedical Research, University of Granada, using ELISA system Gluthathione Peroxidase Activity (uU/g Hb)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Retinol</measure>
    <time_frame>8th week of observation</time_frame>
    <description>Content of antioxidant compounds in plasma; Scientific Instrumentation Center, University of Granada.&#xD;
Retinol (mg/dl)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Alpha-tocopherol</measure>
    <time_frame>8th week of observation</time_frame>
    <description>Content of antioxidant compounds in plasma; Scientific Instrumentation Center, University of Granada.&#xD;
Alpha-tocopherol (mg/l)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Beta-Carotenes</measure>
    <time_frame>8th week of observation</time_frame>
    <description>Content of antioxidant compounds in plasma; Scientific Instrumentation Center, University of Granada.&#xD;
Beta-carotenes (mg/l)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Coenzyme Q9</measure>
    <time_frame>8th week of observation</time_frame>
    <description>Content of antioxidant compounds in plasma; Scientific Instrumentation Center, University of Granada.&#xD;
Coenzyme Q9 (mg/l)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Coenzyme Q10</measure>
    <time_frame>8th week of observation</time_frame>
    <description>Content of antioxidant compounds in plasma; Scientific Instrumentation Center, University of Granada.&#xD;
Coenzyme Q10 (mg/l)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Plasma Interleukin-1B</measure>
    <time_frame>8th week of observation</time_frame>
    <description>Plasma Interleukines; measured at the Institute of Nutrition and Food Technology, Center of Biomedical Research, University of Granada, using the Luminex system:&#xD;
Plasma IL-1B (pg/ml)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Plasma Interleukin-6</measure>
    <time_frame>8th week of observation</time_frame>
    <description>Plasma Interleukines; measured at the Institute of Nutrition and Food Technology, Center of Biomedical Research, University of Granada, using the Luminex system:&#xD;
Plasma IL-6 (pg/ml)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Plasma Interleukin-8</measure>
    <time_frame>8th week of observation</time_frame>
    <description>Plasma Interleukines; measured at the Institute of Nutrition and Food Technology, Center of Biomedical Research, University of Granada, using the Luminex system:&#xD;
Plasma IL-8 (pg/ml)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Plasma Interleukin-10</measure>
    <time_frame>8th week of observation</time_frame>
    <description>Plasma Interleukines; measured at the Institute of Nutrition and Food Technology, Center of Biomedical Research, University of Granada, using the Luminex system:&#xD;
Plasma IL-10 (pg/ml)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Plasma Tumor Necrosis Factor-Alpha</measure>
    <time_frame>8th week of observation</time_frame>
    <description>Plasma Interleukines; measured at the Institute of Nutrition and Food Technology, Center of Biomedical Research, University of Granada, using the Luminex system:&#xD;
Plasma Tumor Necrosis Factor-Alpha (pg/ml)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Saliva Interleukin-1B</measure>
    <time_frame>8th week of observation</time_frame>
    <description>Saliva Interleukines; measured at the Institute of Nutrition and Food Technology, Center of Biomedical Research, University of Granada, using the Luminex system: Saliva IL-1B (pg/ml)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Saliva Interleukin-6</measure>
    <time_frame>8th week of observation</time_frame>
    <description>Saliva Interleukines; measured at the Institute of Nutrition and Food Technology, Center of Biomedical Research, University of Granada, using the Luminex system: Saliva IL-6 (pg/ml)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Saliva Interleukin-8</measure>
    <time_frame>8th week of observation</time_frame>
    <description>Saliva Interleukines; measured at the Institute of Nutrition and Food Technology, Center of Biomedical Research, University of Granada, using the Luminex system: Saliva IL-8 (pg/ml)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Saliva Interleukin-10</measure>
    <time_frame>8th week of observation</time_frame>
    <description>Saliva Interleukines; measured at the Institute of Nutrition and Food Technology, Center of Biomedical Research, University of Granada, using the Luminex system Saliva IL-10 (pg/ml)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Saliva Tumor Necrosis Factor-Alpha</measure>
    <time_frame>8th week of observation</time_frame>
    <description>Saliva Interleukines; measured at the Institute of Nutrition and Food Technology, Center of Biomedical Research, University of Granada, using the Luminex system:&#xD;
Saliva Tumor Necrosis Factor-Alpha (pg/ml)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fecal Calprotectin</measure>
    <time_frame>8th week of observation</time_frame>
    <description>Fecal Calprotectin (mg/kg) measured using the ELISA assay kit from Calpro-Lab (Catalog # CAL0100).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Intestinal Parasitosis</measure>
    <time_frame>8th week of observation</time_frame>
    <description>Intestinal Parasitosis, measured by Biochemistry Laboratory, La Democracia Hospital, Quetzaltenango, Guatemala. Parasite cysts presence in feces.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Giardiasis Infection Presence-1</measure>
    <time_frame>7th week of observation</time_frame>
    <description>Analyses done by ELISA assay kit (ProSpecT Giardia EZ, catalog #R2458596), absorbance (O.D)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Giardiasis Infection Presence-2</measure>
    <time_frame>8th week of observation</time_frame>
    <description>Analyses done by ELISA assay kit (ProSpecT Giardia EZ, catalog #R2458596), absorbance (O.D)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>White Urine Cell Count</measure>
    <time_frame>8th week of observation</time_frame>
    <description>White urine cell count (per field), to be determined in Biochemistry Laboratory in La Democracia Hospital, Quetzaltenango Guatemala.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>White Blood Cell Count</measure>
    <time_frame>8th week of observation</time_frame>
    <description>White blood cell count (cells/ul), to be determined in Biochemistry Laboratory in La Democracia Hospital, Quetzaltenango Guatemala.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">91</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Apparently Healthy</arm_group_label>
    <description>Apparently healthy preschool children who attend 3 daycare centers of the Secretariat of Beneficials Works of the First Lady in Guatemalan Western Highlands</description>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Urine, feces, saliva and blood&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Apparently healthy children who attend 3 daycare centers (one semi-urban, one&#xD;
        urban-marginal and one rural) from the Secretariat of Beneficial Works of the First Lady&#xD;
        (SOSEP) system in the Western Highlands in Quetzaltenango, Guatemala.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  To be attending one of the SOSEP systems assigned daycare centers&#xD;
&#xD;
          -  To maintain an attendance of 80% during the 8 weeks of the fieldwork&#xD;
&#xD;
          -  Aged 23 to 84 months&#xD;
&#xD;
          -  Being apparently healthy and with no dietary restrictions related to the foods offered&#xD;
             with the SOSEP menu.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Children whose parents of caregivers did not sign a consent form&#xD;
&#xD;
          -  Children who refused to participate in the study&#xD;
&#xD;
          -  Children who refused to adhere to the collections routines.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>23 Months</minimum_age>
    <maximum_age>84 Months</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Maria J. Soto-Méndez, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Center for Studies of Sensory Impairment, Aging and Metabolism</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Center for Studies of Sensory Impairment Aging and Metabolism</name>
      <address>
        <city>Guatemala</city>
        <state>Quetzaltenango</state>
        <zip>09001</zip>
        <country>Guatemala</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Guatemala</country>
  </location_countries>
  <results_reference>
    <citation>Soto-Méndez M, Campos-Oliva R, Aguilera C, Solomons N, Schümann K, Gil A. Urinary osmolality of preschool children with a largely common weekday meal offering, from the western highlands of Guatemala. Spanish J Community Nutr. 20:13-9, 2014.</citation>
  </results_reference>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 25, 2014</study_first_submitted>
  <study_first_submitted_qc>July 28, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 30, 2014</study_first_posted>
  <last_update_submitted>July 28, 2014</last_update_submitted>
  <last_update_submitted_qc>July 28, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 30, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Center for Studies of Sensory Impairment, Aging and Metabolism</investigator_affiliation>
    <investigator_full_name>María José Soto</investigator_full_name>
    <investigator_title>PhD student and nutrition researcher</investigator_title>
  </responsible_party>
  <keyword>Growth</keyword>
  <keyword>Hematology</keyword>
  <keyword>Hydration</keyword>
  <keyword>Oxidation</keyword>
  <keyword>Infection</keyword>
  <keyword>Inflammation</keyword>
  <keyword>Guatemalan children</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Inflammation</mesh_term>
  </condition_browse>
  <!-- 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/NCT02203890
org study id: CeSSIAM_02
nct id: NCT02203890
lead sponsor: 
collaborator: 
has dmc: No
This study will provide the researchers with an opportunity for the investigation of the
      biomarkers and different human biology component variable interactions in children;
      information that can generate new correlations between markers not known at the moment.

      Regarding their analysis, variation could have multiple connotations. A categorical that
      refers to a specific state, established with a diagnostic standard. And a numerical,
      referring to a range or the absolute value limits in a continuous spectrum; this research
      will allow us to express variability in the distance amplitude of the obtained values level,
      as well as classifications or categories previously established in the possible cases.

      OBJECTIVES PRINCIPAL OBJECTIVE

      To estimate the inter and intra-individual variety in a selected series or biological
      variables determinant of growth, body composition, infection, oxidation, inflammation and
      hydration, in preschool children sharing the same institutional-based diet.

      SPECIFIC OBJECTIVES

        -  To determine the inter and intra-individual variation of growth in preschool children,
           with a similar diet, who attend Secretariat of Beneficial Works of the First Lady system
           daycare centers and to compare between semi-urban and rural.

        -  To describe the inter-individual variation of the red blood cells circulating mass in
           preschool children, with a similar diet, who attend day care centers and to compare
           between semi-urban and rural.

        -  To determine the inter-individual variation of systemic and intraintestinal oxidation in
           preschool children, with a similar diet, who attend daycare centers and to compare
           between semi-urban and rural.

        -  To describe the inter-individual variation of systemic and intraintestinal inflammation
           in preschool children, with a similar diet, who attend daycare centers and to compare
           between semi-urban and rural.

        -  To determine the inter and/or intra-individual variation of urinary tract infection and
           gastrointestinal parasite infestation in preschool children, with a similar diet, who
           attend daycare centers and to compare between semi-urban and rural.

        -  To describe the inter and intra-individual variation of the hydration status in
           preschool children, with a similar diet, who attend daycare centers and to compare
           between semi-urban and rural.

        -  To explore intra-individual associations in variables of the same research component or
           different component variables.
Please note protocol is also available in Spanish.
observational model: Cohort
time perspective: Cross-Sectional
measure: Weight
time frame: 7th week of observation
description: Growth, measured trough weight (kg)
measure: Hemoglobin
time frame: 8th week of observation
description: Hemoglobin (mg/dl) measured in Biochemistry Laboratory in La Democracia Hospital, Quetzaltenango, Guatemala.
measure: Urine Osmolality-1
time frame: 6th week of observation
description: Hydration Status= measured in 24-h urine through urine volume and osmolality in osmometer Model Löser 815. Results in mOsm/kg.
measure: Height
time frame: 7th week of observation
description: Growth, measured trough height (cm).
measure: Urine Osmolality-2
time frame: 7th week of observation
description: Hydration Status= measured in 24-h urine through urine volume and osmolality Osmometer Model Löser 815. Results in mOsm/kg.
measure: Urine Osmolality-3
time frame: 8th week of observation
description: Hydration Status= measured in 24-h urine through urine volume and osmolality in two different osmometers (Löser 815 and Osmomat 030). Results in mOsm/kg.
measure: Urine Urea
time frame: 8th week of oservation
description: Urine solutes measured by the Scientific Instrumentation Center from the Granada University, Spain:
urea (mg/l)
measure: Urine Uric Acid
time frame: 8th week of oservation
description: Urine solutes measured by the Scientific Instrumentation Center from the Granada University, Spain:
uric acid (mg/l)
measure: Urine Sodium
time frame: 8th week of oservation
description: Urine solutes measured by the Scientific Instrumentation Center from the Granada University, Spain:
sodium (mg/l)
measure: Urine Potassium
time frame: 8th week of oservation
description: Urine solutes measured by the Scientific Instrumentation Center from the Granada University, Spain:
potassium (mg/l)
measure: Urine Calcium
time frame: 8th week of oservation
description: Urine solutes measured by the Scientific Instrumentation Center from the Granada University, Spain:
calcium (mg/l)
measure: Urine Magnesium
time frame: 8th week of oservation
description: Urine solutes measured by the Scientific Instrumentation Center from the Granada University, Spain:
magnesium (mg/l)
measure: Urine Phosphorus
time frame: 8th week of oservation
description: Urine solutes measured by the Scientific Instrumentation Center from the Granada University, Spain:
inorganic phosphorus (mg/l)
measure: Urine 15-f2t-Isoprostanes
time frame: 8th week of observation
description: Urine Oxidation biomarkers:
15-f2t-Isoprostanes (ng/mL) Measured at the Institute of Nutrition and Food Technology, Center of Biomedical Research, University of Granada using ELISA assay kit (Oxford Biomedical Research, Inc., Catalog # EA84.102606, Michigan, USA)
measure: Urine 8-Hydroxydeoxyguanosine
time frame: 8th week of observation
description: Urine Oxidation biomarkers:
8-Hydroxydeoxyguanosine (ng/mL) Measured at the Institute of Nutrition and Food Technology, Center of Biomedical Research, University of Granada using ELISA assay kits (JaICA, Nikken SEIL Co., Ltd, Catalog# IM-KOGHS 040914E, Shizouka, Japan).
measure: Catalase Activity
time frame: 8th week of observation
description: Activity of antioxidant enzymes in red blood cells; measured at the Institute of Nutrition and Food Technology, Center of Biomedical Research, University of Granada, using ELISA system:
Catalase Activity (nmol/seg/g Hb)
measure: Superoxide Dismutase Activity
time frame: 8th week of observation
description: Activity of antioxidant enzymes in red blood cells; measured at the Institute of Nutrition and Food Technology, Center of Biomedical Research, University of Granada, using ELISA system Superoxide Dismutase Activity (U/g Hb)
measure: Gluthathione Reductase
time frame: 8th week of observation
description: Activity of antioxidant enzymes in red blood cells; measured at the Institute of Nutrition and Food Technology, Center of Biomedical Research, University of Granada, using ELISA system Gluthathione Reductase Activity (umol/min/g Hb)
measure: Gluthathione Peroxidase
time frame: 8th week of observation
description: Activity of antioxidant enzymes in red blood cells; measured at the Institute of Nutrition and Food Technology, Center of Biomedical Research, University of Granada, using ELISA system Gluthathione Peroxidase Activity (uU/g Hb)
measure: Retinol
time frame: 8th week of observation
description: Content of antioxidant compounds in plasma; Scientific Instrumentation Center, University of Granada.
Retinol (mg/dl)
measure: Alpha-tocopherol
time frame: 8th week of observation
description: Content of antioxidant compounds in plasma; Scientific Instrumentation Center, University of Granada.
Alpha-tocopherol (mg/l)
measure: Beta-Carotenes
time frame: 8th week of observation
description: Content of antioxidant compounds in plasma; Scientific Instrumentation Center, University of Granada.
Beta-carotenes (mg/l)
measure: Coenzyme Q9
time frame: 8th week of observation
description: Content of antioxidant compounds in plasma; Scientific Instrumentation Center, University of Granada.
Coenzyme Q9 (mg/l)
measure: Coenzyme Q10
time frame: 8th week of observation
description: Content of antioxidant compounds in plasma; Scientific Instrumentation Center, University of Granada.
Coenzyme Q10 (mg/l)
measure: Plasma Interleukin-1B
time frame: 8th week of observation
description: Plasma Interleukines; measured at the Institute of Nutrition and Food Technology, Center of Biomedical Research, University of Granada, using the Luminex system:
Plasma IL-1B (pg/ml)
measure: Plasma Interleukin-6
time frame: 8th week of observation
description: Plasma Interleukines; measured at the Institute of Nutrition and Food Technology, Center of Biomedical Research, University of Granada, using the Luminex system:
Plasma IL-6 (pg/ml)
measure: Plasma Interleukin-8
time frame: 8th week of observation
description: Plasma Interleukines; measured at the Institute of Nutrition and Food Technology, Center of Biomedical Research, University of Granada, using the Luminex system:
Plasma IL-8 (pg/ml)
measure: Plasma Interleukin-10
time frame: 8th week of observation
description: Plasma Interleukines; measured at the Institute of Nutrition and Food Technology, Center of Biomedical Research, University of Granada, using the Luminex system:
Plasma IL-10 (pg/ml)
measure: Plasma Tumor Necrosis Factor-Alpha
time frame: 8th week of observation
description: Plasma Interleukines; measured at the Institute of Nutrition and Food Technology, Center of Biomedical Research, University of Granada, using the Luminex system:
Plasma Tumor Necrosis Factor-Alpha (pg/ml)
measure: Saliva Interleukin-1B
time frame: 8th week of observation
description: Saliva Interleukines; measured at the Institute of Nutrition and Food Technology, Center of Biomedical Research, University of Granada, using the Luminex system: Saliva IL-1B (pg/ml)
measure: Saliva Interleukin-6
time frame: 8th week of observation
description: Saliva Interleukines; measured at the Institute of Nutrition and Food Technology, Center of Biomedical Research, University of Granada, using the Luminex system: Saliva IL-6 (pg/ml)
measure: Saliva Interleukin-8
time frame: 8th week of observation
description: Saliva Interleukines; measured at the Institute of Nutrition and Food Technology, Center of Biomedical Research, University of Granada, using the Luminex system: Saliva IL-8 (pg/ml)
measure: Saliva Interleukin-10
time frame: 8th week of observation
description: Saliva Interleukines; measured at the Institute of Nutrition and Food Technology, Center of Biomedical Research, University of Granada, using the Luminex system Saliva IL-10 (pg/ml)
measure: Saliva Tumor Necrosis Factor-Alpha
time frame: 8th week of observation
description: Saliva Interleukines; measured at the Institute of Nutrition and Food Technology, Center of Biomedical Research, University of Granada, using the Luminex system:
Saliva Tumor Necrosis Factor-Alpha (pg/ml)
measure: Fecal Calprotectin
time frame: 8th week of observation
description: Fecal Calprotectin (mg/kg) measured using the ELISA assay kit from Calpro-Lab (Catalog # CAL0100).
measure: Intestinal Parasitosis
time frame: 8th week of observation
description: Intestinal Parasitosis, measured by Biochemistry Laboratory, La Democracia Hospital, Quetzaltenango, Guatemala. Parasite cysts presence in feces.
measure: Giardiasis Infection Presence-1
time frame: 7th week of observation
description: Analyses done by ELISA assay kit (ProSpecT Giardia EZ, catalog #R2458596), absorbance (O.D)
measure: Giardiasis Infection Presence-2
time frame: 8th week of observation
description: Analyses done by ELISA assay kit (ProSpecT Giardia EZ, catalog #R2458596), absorbance (O.D)
measure: White Urine Cell Count
time frame: 8th week of observation
description: White urine cell count (per field), to be determined in Biochemistry Laboratory in La Democracia Hospital, Quetzaltenango Guatemala.
measure: White Blood Cell Count
time frame: 8th week of observation
description: White blood cell count (cells/ul), to be determined in Biochemistry Laboratory in La Democracia Hospital, Quetzaltenango Guatemala.
arm group label: Apparently Healthy
description: Apparently healthy preschool children who attend 3 daycare centers of the Secretariat of Beneficials Works of the First Lady in Guatemalan Western Highlands
Urine, feces, saliva and blood
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 23 Months
maximum age: 84 Months
healthy volunteers: Accepts Healthy Volunteers
last name: Maria J. Soto-Méndez, MSc
role: Principal Investigator
affiliation: Center for Studies of Sensory Impairment, Aging and Metabolism
facility: 
country: Guatemala
citation: Soto-Méndez M, Campos-Oliva R, Aguilera C, Solomons N, Schümann K, Gil A. Urinary osmolality of preschool children with a largely common weekday meal offering, from the western highlands of Guatemala. Spanish J Community Nutr. 20:13-9, 2014.
responsible party type: Sponsor-Investigator
investigator affiliation: Center for Studies of Sensory Impairment, Aging and Metabolism
investigator full name: María José Soto
investigator title: PhD student and nutrition researcher
mesh term: Infections
mesh term: Inflammation