<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT2017021315536N6</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-04-07</date_registration>
      <primary_sponsor>Vice Chancellor for research of Tehran University of Medical Sciences</primary_sponsor>
      <public_title>The Ready-to-Use Supplementary Food 's impact on indicators of Children malnutrition</public_title>
      <acronym></acronym>
      <scientific_title>The Ready-to-Use Supplementary Food 's impact on indicators of malnutrition in Mild and Moderately Wasted Children: a randomized controlled trial.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-02-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>106</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/14787</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Children will be numbered, and randomly will be assigned into two groups (Control and Intervention groups) by random number tables.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: moderate malnutrition. Condition 2: mild malnutrition.</hc_freetext>
      <i_freetext>Intervention 1: Control group: before and during intervention, in four half-hour sessions, caregivers will be trained about Childhood nutrition by face to face method.  The subjects of education sessions will be the adequacy of feeding; the correct number of meals; type and amount of food each meal should have, based on the child's age; sensory characteristics and diversity of food; hygiene; and how to prepare energetic nutritious foods. Intervention 2: Intervention group: The Ready-to-Use Supplementary Food, which contains whey protein, egg white, soy, palm, starch, honey, sugar, oil and natural flavorings will be given to children as daily snacks for eight weeks. On average, each of them should consume one to three packs (100 grams), daily. Like control group, before and during intervention, caregivers will be trained about Childhood nutrition by face to face education. The subjects of education sessions will be the adequacy of feeding; the correct number of meals; type and amount of food each meal should have, based on the child's age; sensory characteristics and diversity of food; hygiene; and how to prepare energetic nutritious foods.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohamad Javad Hosseinzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 44, Hojat Dust aven, Naderi street, Keshavarz bolivar</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 8895 5975</telephone>
        <email>hosseinzadeh.md.phd@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences Department of Nutrition and Dietetic</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad Javad Hosseinzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 44, Hojatdoost st, Naderi Ave, Keshavarz Blv</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 218893059</telephone>
        <email>mhosseinzadeh@tums.ac.ir</email>
        <affiliation>School of Nutritional sciences and dietetics TUMS</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Having age 24 to 59 months; Mild and moderate malnutrition without edema (Anthropometric index of weight for height between the -1 and -3 z-score); Filling a consent form.&#13;
Exclusion criteria: Being twins; Food allergies and intolerance; Severe anemia; Liver-kidney disease; Malabsorption syndrome; Lack of cooperation.</inclusion_criteria>
      <agemin>2 years</agemin>
      <agemax>4 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E44.0</hc_code>
      <hc_code>E44.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Moderate protein-energy malnutrition</hc_keyword>
      <hc_keyword>Mild protein-energy malnutrition</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: before and during intervention, in four half-hour sessions, caregivers will be trained about Childhood nutrition by face to face method.  The subjects of education sessions will be the adequacy of feeding; the correct number of meals; type and amount of food each meal should have, based on the child's age; sensory characteristics and diversity of food; hygiene; and how to prepare energetic nutritious foods.</i_keyword>
      <i_keyword>Intervention group: The Ready-to-Use Supplementary Food, which contains whey protein, egg white, soy, palm, starch, honey, sugar, oil and natural flavorings will be given to children as daily snacks for eight weeks. On average, each of them should consume one to three packs (100 grams), daily. Like control group, before and during intervention, caregivers will be trained about Childhood nutrition by face to face education. The subjects of education sessions will be the adequacy of feeding; the correct number of meals; type and amount of food each meal should have, based on the child's age; sensory characteristics and diversity of food; hygiene; and how to prepare energetic nutritious foods.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Recovery. Timepoint: Every two weeks after intervention. Method of measurement: Increase children's weight for height anthropometric index z-score to the top of -1 in weight-for-height tables Children's World Health Organization, Weight will be measured with scale, and height will be measured with meter.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Weight gain. Timepoint: two month after intervention. Method of measurement: difference between New weight at the end of intervention and children's initial weight. Weight will be measured with scale.</sec_outcome>
      <sec_outcome>Height gain. Timepoint: two month after intervention. Method of measurement: difference between New height at the end of intervention and children's initial height. height will be measured with meter.</sec_outcome>
      <sec_outcome>Fever. Timepoint: two month after intervention. Method of measurement: Counting the number of days of fever from the beginning to the end of the study. method of measurement is With question.</sec_outcome>
      <sec_outcome>Diarrhea. Timepoint: two month after intervention. Method of measurement: Counting the number of days of Diarrhea from the beginning to the end of the study. . method of measurement is With question.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Vice Chancellor for research of Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-07-25</approval_date>
        <contact_name>Ethics Committee of Tehran University of Medical Sciences</contact_name>
        <contact_address>6th floor, Central Tehran University, Ghods street, Keshavarz Bolivar. Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
