<?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>IRCT2014111519951N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-02-12</date_registration>
      <primary_sponsor>Nutrition Department of Ministry of Health and Medical  Education</primary_sponsor>
      <public_title>Efficacy of zinc supplementation among 6 months to 2 years old children on height and prevention of infectious diseases</public_title>
      <acronym></acronym>
      <scientific_title>Evaluating the feasibility and effectiveness of zinc supplementation on height, weight and serum Ferritin amongst children aged 6-24 months in Pishva/Varamin and Damavand</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-08-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>880</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/17712</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Health service research.</study_design>
      <phase>N/A</phase>
      <hc_freetext>zinc deficiency.</hc_freetext>
      <i_freetext>Intervention 1: zinc sulfate suspension 60 ML. Intervention 2: placebo suspension 60 ML.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary>Background: Zinc is one of the vital minerals which are found naturally in many foods. Zinc deficiency may cause organs dysfunctions. Zinc deficiency in infancy and childhood when the growth velocity is high may lead to some irreversible outcomes. One of the problems in many developing countries including Iran is failure to thrive. Some national studies showed 15% of failure to thrive occurrence in Iran. As the zinc deficiency is remarkable among children in Iran it probably contributes to the prevalence of failure to thrive. Therefore, present study aimed to evaluate the feasibility and effectiveness of zinc supplementation on height, weight growth and serum levels of zinc as well as determining the interaction between zinc and iron amongst children aged 6-24 months in Pishva, Varamin and Damavand.&lt;br /&gt;&#13;
&lt;br /&gt;&#13;
Methods: Present study is an effectiveness trial which has been conducted in 25 rural health care offices in Pishva, Damavand and Varamin randomly assigned to zinc and placebo syrup. 839 children aged 6-24 months were screened of whom 570 started the trial. The health officers and the families were blinded to the type of the syrup. Before the study, the protocol and side effects of zinc syrup including nausea, vomiting and abdominal pain was explained for mothers of children. Children were categorized randomly into two groups, case (receiving 5 ml of zinc syrup containing 5 mg elemental zinc =272) and control (receiving 5 ml of placebo syrup=308). Children were followed up for 6 month and received zinc syrup or placebo daily. The anthropometric measurements including height and weight were measured monthly. 200 children were selected randomly (100 from case and 100 from control group) to determine their dietary patterns using 3 days food recalls. Blood samples were drawn from these 200 children in order to measure the serum levels of zinc and Ferritin and hs-CRP. HAZ and HWZ were calculated for all the participants based on the WHO standards. &lt;br /&gt;&#13;
&lt;br /&gt;&#13;
Results: The mean age of case and control groups was almost similar (15.5 ± 5.3 vs 16.3 ± 5.1 month). 49.1% of participants were girl and 50.9 % were boys of whom 15.6% were categorized into the age range of 6-12months, 38.6% into 12-18 months and 35.6% into 18-24 months. No significant differences were observed in age and height of children between two groups at baseline and end of the study. The height differences were significantly different between intervention and control group (5.79 ± 2.18 vs 5.23 ± 2.19 cm, respectively). After 6 month of supplementation, no significant differences in terms of zinc, ferritin and hs-CRP level between two groups were observed. The occurrence of zinc deficiency among the supplemented groups was lower at the end of the study compared with baseline. Besides, results of the present study showed no interaction between zinc and ferritin levels as well as differences in dietary pattern between two groups. No major complications were observed. The compliance of the mothers and their children was very good.&lt;br /&gt;&#13;
&lt;br /&gt;&#13;
Conclusion: Incorporating zinc supplementation in routine care of the children by the health system is feasible and is effective in terms of height growth. &lt;br /&gt;&#13;
&lt;br /&gt;&#13;
Key words: zinc supplement, ferritin, children growth &lt;br /&gt;&#13;
            </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>Dr.Morteza Abdollahi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.7, West Arghavan st., Farahzadi Blvd., Qarb, Tehran-Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 912 148 0902</telephone>
        <email>Morabd@yahoo.com</email>
        <affiliation>Faculty Of Nutrition Science And Food Technology  Shahid Beheshti University Of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr.Morteza Abdollahi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.7, West Arghavan st., Farahzadi Blvd., Qarb, Tehran-Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 912 147 0902</telephone>
        <email>morabd@yahoo.com</email>
        <affiliation>Faculty Of Nutrition Sciences And Food Technology Shahid Beheshti University Of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>inclusion criteria: age range 6-24 months; apparently healthy; agreement for participate in the study&#13;
&#13;
exclusion criteria: with severe disease; rejection of the supplement</inclusion_criteria>
      <agemin>6 months</agemin>
      <agemax>1 year</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E60</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Dietary zinc deficiency</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>zinc sulfate suspension 60 ML.</i_keyword>
      <i_keyword>placebo suspension 60 ML</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Zinc level. Timepoint: at beginning and end of the intervention. Method of measurement: in percentage of mg in taken blood sample.</prim_outcome>
      <prim_outcome>Ferritin level. Timepoint: at beginning and end of the intervention. Method of measurement: in percentage of mg in taken blood sample.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Height. Timepoint: monthly from beginning to end of the intervention. Method of measurement: in Cm measured by stadiometer.</sec_outcome>
      <sec_outcome>Weight. Timepoint: monthly from beginning to end of the intervention. Method of measurement: In Kg measured by special weighing scale.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name>Unicef</sponsor_name>
      <sponsor_name>National Nutrition And Food Technology Research Institute</sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Nutrition Department of Ministry of Health and Medical  Education</source_name>
      <source_name>Unicef</source_name>
      <source_name>National Nutrition And Food Technology Research Institute</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-10-07</approval_date>
        <contact_name>Ethics Committee of National Nutrition and Food Technology Research Institute</contact_name>
        <contact_address>No.7, West Arghavan st., Farahzadi Blvd., Qarb, Tehran-Iran Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
