<?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>IRCT20210730052015N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-09-25</date_registration>
      <primary_sponsor>Arak University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the effectiveness of treatment of iron deficiency anemia with daily vs. every other day oral iron supplementation</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effectiveness of treatment of iron deficiency anemia with daily vs. every other day oral iron supplementation</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-09-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>376</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/58507</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, randomized block method was used for randomization. For this purpose, a block of 4 is used. In such a way that first 4 blocks are prepared as BAAB, BABA, BBAA, AABB, ABAB, ABB and then these blocks are arranged randomly and people are assigned to two groups according to A or B and this work is continuous. Will be repeated to reach the desired sample size, Blinding description: The study is one-sided blind, which means that none of the participants is aware of how individuals are assigned to the groups. Labels A and B are labeled on the packages, but only the researcher knows the true nature of the supplements.</study_design>
      <phase>3</phase>
      <hc_freetext>Iron deficiency anemia.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In one group of patients, 150-200 mg of elemental iron is given daily (in the form of ferrofort tablets of Abidi Pharmaceutical Company twice a day). Intervention 2: Intervention group: In the second group, patients are treated every other daybetween 150-200 mg of elemental iron (in the form of ferrufort tablets of Abidi company twice a day every other day).</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
All data is potentially shareable after unidentified individuals

When:
Access period starts 6 months after the results are published

To whom:
Researchers working in academic and scientific institutions

Conditions:
Students and researchers can use the data of this study.

Where to obtain:
Researchers can contact the study author via email at Drnegar.gheytassi@gmail.com to receive data and information.

How to obtain:
Request information and data to the author via email Drnegar.gheytassi@gmail.com

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Negar Gheytassi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Amir Al-Momenin Hospital, Next to the School of Medicine, Basij Square (Sardasht), Arak</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3848176941</zip>
        <telephone>+98 86 3417 3601</telephone>
        <email>Drnegar.gheytassi@gmail.com</email>
        <affiliation>Arak University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Negar.Gheytassi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Amir Al-Momenin Hospital, Next to the School of Medicine, Basij Square (Sardasht), Arak</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3848176941</zip>
        <telephone>+98 86 3417 3601</telephone>
        <email>Drnegar.gheytassi@gmail.com</email>
        <affiliation>Arak University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age ≥ 15 years and less than 50 years
outpatients Women with iron deficiency  with ferritin less than 30 micrograms per liter
No pregnancy
No breastfeeding right now
Absence of comorbidities (ckd, DM, IHD, etc.)
Lack of known history of inflammatory bowel disease
Lack of known history of celiac disease
No known history or thalassemia
No known hereditary bleeding disorder
Do not take multivitamin and mineral supplements (35 mg or more of essential iron per day) in the 2 weeks prior to randomization.
No allergy to oral iron
Lack of intravenous iron therapy in the last 12 weeks
Do not receive anticoagulants (eg warfarin, apixaban, debigatran, adoxaban, Riveroxban)
Lack of creatinine clearance less than 30 ml per minute
Lack of hemoglobin less than 80 g / l with active bleeding
No chemotherapy planned for the next 12 weeks.
No surgery is scheduled for the next 12 weeks.</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>50 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Intolerance or non-response to oral iron gluconate, sulfate or fumarate in the last 12 weeks
Received frequent anemia treatments and are resistant to anemia treatment.
Dissatisfaction to participate in the study or lack of cooperation and consent to continue treatment</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In one group of patients, 150-200 mg of elemental iron is given daily (in the form of ferrofort tablets of Abidi Pharmaceutical Company twice a day).</i_keyword>
      <i_keyword>Intervention group: In the second group, patients are treated every other daybetween 150-200 mg of elemental iron (in the form of ferrufort tablets of Abidi company twice a day every other day).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Hemoglobin. Timepoint: The beginning of the study, two weeks and a month and a half after the intervention. Method of measurement: Using the device.</prim_outcome>
      <prim_outcome>Ferritin. Timepoint: At the beginning of the study and one and a half months after the intervention. Method of measurement: Using the device.</prim_outcome>
      <prim_outcome>Retic  COUNT. Timepoint: First and two weeks after the intervention. Method of measurement: Using the device.</prim_outcome>
      <prim_outcome>Serum iron levels. Timepoint: At the beginning of the study and one and a half months after the intervention. Method of measurement: Using the device.</prim_outcome>
      <prim_outcome>TIBC. Timepoint: At the beginning of the study and one and a half months after the intervention. Method of measurement: Using the device.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>General clinical symptoms(weakness, fatigue, drowsiness, restlessness, anxiety, etc.). Timepoint: at the beginning and end of the study. Method of measurement: check list.</sec_outcome>
      <sec_outcome>Side effects during the study (nausea and vomiting, black stools / heartburn, etc.). Timepoint: during the study. Method of measurement: check list.</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>Arak University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-06-27</approval_date>
        <contact_name>Ethics committee of Arak University of Medical Sciences</contact_name>
        <contact_address>University of Medical Sciences, Payambar Azam University Complex. Deputy of research and technology Arak Markazi Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
