<?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>IRCT20201124049481N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-08-12</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the effect of high protein diet in people at risk of premature menopause</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of three high  animal protein diet , high  plant protein and common protein on indicators related to ovarian aging (premature menopause) in people at risk of premature ovarian failure: a clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/52562</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Prevention, Randomization description: Sampling will be done in a stratified manner using random permutation blocks. For this purpose, first individuals are classified based on body mass index and then for each category using random block method of individuals in two groups of intervention and a control Will be appointed. The randomization unit is individual. Statistical software is used for randomization.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Premature menopause.</hc_freetext>
      <i_freetext>Intervention 1: Group 1: Animal high protein diet. Intervention 2: Intervention group: Intervention group: high protein plant diet.</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:
========

When:
Up to two months after the end of the intervention

To whom:
Professors and students in the field of nutrition

Conditions:
or more extensive research on this disease

Where to obtain:
To Shahid Beheshti School of Nutrition, Dr. Mirmiran

How to obtain:
Must be approved by the supervisor Dr. Mirmiran

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Marjan bedakhanian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 7, Hafezi St., Shahid Farahzadi Blvd., Ghods Town (West), Tehran, Iran Institute of Nutrition and Food Industry Research</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1981619573</zip>
        <telephone>0000000</telephone>
        <email>marjanbadakhanian@ymail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Marjan bedakhanian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 7, Hafezi St., Shahid Farahzadi Blvd., Ghods Town (West), Tehran, Iran Institute of Nutrition and Food Industry Research</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1981619573</zip>
        <telephone>00000000</telephone>
        <email>marjanbadakhanian@ymail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Women in their 20s and 40s who have stopped menstruating or two to three periods a year and have Anti Mullerian hormone level as defined in the scientific definitions and FSH level above 10 IU / L.   are at risk for premature menopause
Normal creatine or GFR levels above 70
No change in supplements (antioxidants)
Informed consent to participate in the study</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>40 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Having a history of radiotherapy
Having a history of ovarian surgery</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E28.31</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Premature menopause</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Group 1: Animal high protein diet</i_keyword>
      <i_keyword>Intervention group: Intervention group: high protein plant diet</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Serum level of Anti Mullerian Hormone. Timepoint: It will be measured at the beginning and end of the study. Method of measurement: It will be measured by ELISA method.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Premature menopause. Timepoint: Not applicable. Method of measurement: Based on the AMH level according to the table mentioned in the.</sec_outcome>
      <sec_outcome>Serum level of Estrogen. Timepoint: At the beginning and 6 months after starting the diet. Method of measurement: It will be measured by ELISA method.</sec_outcome>
      <sec_outcome>Serum level of Progestron. Timepoint: At the beginning and 6 months after starting the diet. Method of measurement: It will be measured by ELISA method.</sec_outcome>
      <sec_outcome>Serum level of Follicle-stimulating hormone (FSH). Timepoint: At the beginning and 6 months after starting the diet. Method of measurement: It will be measured by ELISA method.</sec_outcome>
      <sec_outcome>Serum level of  Luteinizing Hormone (LH). Timepoint: At the beginning and 6 months after starting the diet. Method of measurement: It will be measured by ELISA method.</sec_outcome>
      <sec_outcome>Serum level of Inhibin A. Timepoint: At the beginning and 6 months after starting the diet. Method of measurement: It will be measured by ELISA method.</sec_outcome>
      <sec_outcome>Serum level of Inhibin B. Timepoint: At the beginning and 6 months after starting the diet. Method of measurement: It will be measured by ELISA method.</sec_outcome>
      <sec_outcome>Serum level of C-Reactive Protein. Timepoint: At the beginning and 6 months after starting the diet. Method of measurement: It will be measured by ELISA method.</sec_outcome>
      <sec_outcome>Sonography. Timepoint: At the beginning and end of the study in terms of ovarian volume, number of antral follicles, antral thickness. Method of measurement: Ultrasound device.</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>Shahid Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-05-12</approval_date>
        <contact_name>Institute of Nutrition and Food Industry</contact_name>
        <contact_address>No. 7, Shahid Hafezi St. (West Purple), Shahid Farahzadi Blvd. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
