<?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>IRCT20190831044650N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-08-22</date_registration>
      <primary_sponsor>Sari branch, Islamic Azad University</primary_sponsor>
      <public_title>The effect of high intensity interval resistance training and vitamin D intake onvitamin D th and anti inflammatory-oxidative status in overweight women</public_title>
      <acronym></acronym>
      <scientific_title>The effect of high intensity interval resistance training and vitamin D intake on the levels of Sirtuin1, Eotaxin-1 and some anti inflammatory-oxidative markers in overweight women with low vitamin D status.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-08-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>78</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/57005</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: At first, the subjects will be selected using a simple random method. Then, using a table of random numbers, they are divided into six groups: control, resistance interval, running interval, vitamin D, resistance interval+vitamin D and running  interval+ vitamin D. Therefore, each of the candidates will be assigned a two-digit number from 01, 02, …, 10, 11, …, to 52. The same number of digits is determined for the selection of individuals by starting a hand movement from a point in the table of random numbers in the direction of the desired row or column (five-digit numbers whose last two digits are similar to the existing codes) and each is randomly assigned to One of the groups. This will continue until the number of people in each group is completed. Therefore, the researcher will not have the option to change the status of the assignment or predict it. Random disguise will be done by a third party who does not participate in other stages of the intervention, Blinding description: Analysts will be blind. The researcher will administer vitamin D capsules (50,000 units) to vitamin D, resistance interval+ vitamin D, running interval+ vitamin D individuals as well as placebo to control and exercise groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Overweight. Condition 2: Vitamin D deficiency.</hc_freetext>
      <i_freetext>Intervention 1: Control group: There is no intervention in the control group and they are given placebo in a single blind manner. Intervention 2: Intervention group 1: Vitamin D group, who take 50,000 IU of vitamin D capsules once a week for 8 weeks. Intervention 3: Intervention group 2:   resistance interval group will perform 8 weeks and three times a week of high intensity interval resistance training consisting of three sets of 6 repetitions at 70% of 1repetition maximum (RM) and then 20 seconds of rest between repetitions until exhaustion repeated for 3 times with 2 .30” rest between sets. They will also take a placebo capsule containing oral paraffin weekly. Intervention 4: Intervention group 3:  Subjects in this group will have 8 weeks of high intensity interval resistance training similar to the interval resistance group and will consume 50,000 IU of vitamin D capsules once a week. Intervention 5: Intervention group 3: running interval group will perform 8 weeks and three times a week of high intensity interval running training consisting of 12 x 1-min running bouts at 80-90% HRmax interspersed with 1-min active recovery at 50%HRmax. They will also take a placebo capsule containing oral paraffin weekly. Intervention 6: Intervention group 5:  Subjects in this group will have 8 weeks of high intensity interval running training similar to the interval running group and will consume 50,000 IU of vitamin D capsules once a week.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Masoumeh habibian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>7km Allameh Tabarasi street, Qaemshahr Branch, Islamic Azad University, Qaemshahr</address>
        <city>Qaemshahr</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4765161964</zip>
        <telephone>+98 11 4224 1041</telephone>
        <email>habibian_m@yahoo.com</email>
        <affiliation>Qaemshahr branch, Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Masoumeh Habibian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>7 kilometers from Allameh Tabari Street, Islamic Azad University of Ghaemshahr Branch, Ghaemshahr, Iran.</address>
        <city>Ghaemshahr</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4765161964</zip>
        <telephone>+98 11 4224 1041</telephone>
        <email>habibian_m@yahoo.com</email>
        <affiliation>Qaemshahr branch, Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having a body mass index between 25 to 29 kg / m2
Not participating in regular sports activities for the past six months
Not having cardiovascular disease
Not having hypertension
Not having Inflammatory diseases
Serum levels of 25-hydroxyvitamin D less than 30 ng / ml</inclusion_criteria>
      <agemin>23 years</agemin>
      <agemax>29 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Use any specific medications or supplements
Pregnancy
Smoking</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E66.0</hc_code>
      <hc_code>E50.5</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Obesity due to excess calories</hc_keyword>
      <hc_keyword>Vitamin D deficiency</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Placebo</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: There is no intervention in the control group and they are given placebo in a single blind manner</i_keyword>
      <i_keyword>Intervention group 1: Vitamin D group, who take 50,000 IU of vitamin D capsules once a week for 8 weeks.</i_keyword>
      <i_keyword>Intervention group 2:   resistance interval group will perform 8 weeks and three times a week of high intensity interval resistance training consisting of three sets of 6 repetitions at 70% of 1repetition maximum (RM) and then 20 seconds of rest between repetitions until exhaustion repeated for 3 times with 2 .30” rest between sets. They will also take a placebo capsule containing oral paraffin weekly</i_keyword>
      <i_keyword>Intervention group 3:  Subjects in this group will have 8 weeks of high intensity interval resistance training similar to the interval resistance group and will consume 50,000 IU of vitamin D capsules once a week.</i_keyword>
      <i_keyword>Intervention group 3: running interval group will perform 8 weeks and three times a week of high intensity interval running training consisting of 12 x 1-min running bouts at 80-90% HRmax interspersed with 1-min active recovery at 50%HRmax. They will also take a placebo capsule containing oral paraffin weekly.</i_keyword>
      <i_keyword>Intervention group 5:  Subjects in this group will have 8 weeks of high intensity interval running training similar to the interval running group and will consume 50,000 IU of vitamin D capsules once a week.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Eotaxin-1. Timepoint: Before the intervention and 8 weeks after the intervention. Method of measurement: Using the ELISA method.</prim_outcome>
      <prim_outcome>Sirtuin1. Timepoint: Before the intervention and 8 weeks after the intervention. Method of measurement: Using the ELISA method.</prim_outcome>
      <prim_outcome>Interlukin10. Timepoint: Before the intervention and 8 weeks after the intervention. Method of measurement: Using the ELISA method.</prim_outcome>
      <prim_outcome>25- hydroxy vitamin D. Timepoint: Before and after interventions. Method of measurement: Using the ELISA method.</prim_outcome>
      <prim_outcome>Brain-Derived Neurotrophic Factor. Timepoint: Before the intervention and 8 weeks after the intervention. Method of measurement: Using the ELISA method.</prim_outcome>
      <prim_outcome>Superoxide dismutase. Timepoint: Before the intervention and 8 weeks after the intervention. Method of measurement: Laboratory methods.</prim_outcome>
      <prim_outcome>Tumor necrosis factor alpha. Timepoint: Before the intervention and 8 weeks after the intervention. Method of measurement: Using the ELISA method.</prim_outcome>
      <prim_outcome>Monocyte Chemoattractant Protein 1. Timepoint: Before the intervention and 8 weeks after the intervention. Method of measurement: Using the ELISA method.</prim_outcome>
      <prim_outcome>Malondialdehyde. Timepoint: Before the intervention and 8 weeks after the intervention. Method of measurement: spectrophotometrically.</prim_outcome>
      <prim_outcome>Homocysteine. Timepoint: Before the intervention and 8 weeks after the intervention. Method of measurement: Using the ELISA method.</prim_outcome>
      <prim_outcome>Total Antioxidant Capacity. Timepoint: Before the intervention and 8 weeks after the intervention. Method of measurement: Ferric Reducing/Antioxidant Power.</prim_outcome>
      <prim_outcome>Transforming growth factor-beta 1 (TGF-beta1). Timepoint: Before the intervention and 8 weeks after the intervention. Method of measurement: Using the ELISA method.</prim_outcome>
      <prim_outcome>Vascular endothelial growth factor (VEGF). Timepoint: Before the intervention and 8 weeks after the intervention. Method of measurement: Using the ELISA method.</prim_outcome>
      <prim_outcome>C-Reactive Protein (CRP). Timepoint: Before the intervention and 8 weeks after the intervention. Method of measurement: Using the ELISA method.</prim_outcome>
      <prim_outcome>Adiponectin. Timepoint: Before the intervention and 8 weeks after the intervention. Method of measurement: Using the ELISA method.</prim_outcome>
      <prim_outcome>Thyroid stimulating hormone. Timepoint: Before the intervention and 8 weeks after the intervention. Method of measurement: Using the ELISA method.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Sleep quality. Timepoint: Before and after interventions. Method of measurement: Sleep quality questionnaire.</sec_outcome>
      <sec_outcome>Quality of Life. Timepoint: Before the intervention and 2 weeks after the intervention. Method of measurement: Quality of Life Questionnaire.</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>Sari branch, Islamic Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-04-27</approval_date>
        <contact_name>Ethics Committee of  Sari branch, Islamic Azad University</contact_name>
        <contact_address>7 km Darya Road, Sari, Islamic Azad University, Sari Branch, Iran Sari Mazandaran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
