<?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>IRCT20220322054338N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-03-29</date_registration>
      <primary_sponsor>Vice President for Research, University of Sistan and Baluchestan</primary_sponsor>
      <public_title>The effect of vitamin D and calcium supplementation and squat exercises on angiogenesis indices in the elderly</public_title>
      <acronym></acronym>
      <scientific_title>The effect of a course of vitamin D and calcium supplementation along with squat exercises on angiogenesis indices in the elderly</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-04-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>45</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/82109</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Randomization of numbers is done using Random Allocation software and permutation block method. People will be assigned to three groups using ternary permutation blocks. To do this, the letters A, B, and C will be considered for the two intervention and control groups, respectively. The possible states in the ternary block are six states including CAB, BCA, CBA, ACB, BAC, ABC. Each state will be written on a card. The cards will be assigned numbers one to six. Then, one of the six possible states will be selected using dice and based on that, the selected patients will be assigned to three groups. This process will continue until the sample size is completed, Blinding description: Participants in the supplement group will receive 1,000 mg of calcium daily and 50,000 IU of vitamin D weekly. The placebo groups will receive the same number of starch tablets and capsules. Before the study begins, the supplement and placebo packages will be marked by someone other than the researcher so that the researcher and participants are unaware of the type of capsules they are receiving. The supplement and placebo will be administered under the supervision of the same person.</study_design>
      <phase>3</phase>
      <hc_freetext>Elderly.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: 4 weeks of training with supplements, one 1000 mg calcium tablet per day along with one 50000 international units of vitamin D capsule per week and squat exercises 3 sessions a week. Intervention 2: Intervention group: 4 weeks of placebo training, one 1000 mg placebo tablet (containing lactose and edible paraffin) per day, along with one 50,000 IU placebo capsule (corn starch and Avicel) per week, and resistance squat training 3 sessions per week. Intervention 3: Control group: Tracking activities and daily regimen without any interference.</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:
Participants' information will be made available to other researchers after being de-identified

When:
After the publication of the final research report.

To whom:
Researchers

Conditions:
Citing the findings by citing the source

Where to obtain:
Those interested in more information can contact through the email and address below: Mailing address: University of Zabol Email: elhamghasemi@uoz.ac.ir

How to obtain:
Those interested in more information can contact through the email and address below: Mailing address: University of Zabol Email: elhamghasemi@uoz.ac.ir

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Elham Ghasemi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kilometer two of Bonjar road</address>
        <city>zabol</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9861335856</zip>
        <telephone>+98 56 3242 4947</telephone>
        <email>elhamghasemi@uoz.ac.ir</email>
        <affiliation>University of Zabol</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Shila Nayebifar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Daneshgah blvd.</address>
        <city>Zahedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9816745845</zip>
        <telephone>+98 54 3113 6766</telephone>
        <email>shila_nayebifar@ped.usb.ac.ir</email>
        <affiliation>University of Sistan and Baluchestan</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age range is 60-70 years
BMI between 18.5- 25 kg/m2
Inactive lifestyle
Having general physical and mental health</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>70 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Inability to walk
Using the drug
Having chronic diseases, especially cardiovascular diseases</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 - Other</i_code>
      <i_code>Placebo</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: 4 weeks of training with supplements, one 1000 mg calcium tablet per day along with one 50000 international units of vitamin D capsule per week and squat exercises 3 sessions a week.</i_keyword>
      <i_keyword>Intervention group: 4 weeks of placebo training, one 1000 mg placebo tablet (containing lactose and edible paraffin) per day, along with one 50,000 IU placebo capsule (corn starch and Avicel) per week, and resistance squat training 3 sessions per week.</i_keyword>
      <i_keyword>Control group: Tracking activities and daily regimen without any interference</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Fibroblast growth factor. Timepoint: Beginning and end of the intervention. Method of measurement: ELISA.</prim_outcome>
      <prim_outcome>Nitric Oxide. Timepoint: Beginning and end of the intervention. Method of measurement: ELISA.</prim_outcome>
      <prim_outcome>Vascular endothelial growth factor. Timepoint: Beginning and end of the intervention. Method of measurement: ELISA.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Body Mass Index. Timepoint: Beginning and end of the intervention. Method of measurement: Inbody70 body composition analyzer.</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 President for Research, University of Sistan and Baluchestan</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-11-09</approval_date>
        <contact_name>Committee of Ethics in Research of University of Sistan and Baluchistan</contact_name>
        <contact_address>University blvd Zahedan Sistan-va-Balouchestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
