<?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>IRCT2017060334308N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-08-20</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Evaluating the effects of oligopin supplementation on the turnover of bone formation and antioxidant changes in postmenopausal osteopenic women</public_title>
      <acronym></acronym>
      <scientific_title>Evaluating the effects of oligopin supplementation on the turnover of bone formation and antioxidant changes in postmenopausal osteopenic women: A randomized double-blind clinical trial with placebo-concurrent controls</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-08-25</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>44</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/26242</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Randomization was performed for all participants based on age (50–55, 55–60, and 60– 65 years old) and BMI (BMI more than 27.50 kg/m2and less than 27.50 kg/m2) to minimize any bias, Blinding description: Placebo and Oligopin® capsules were distributed by the site research officer who is unaware of the contents of the packages. Patients, health care clinicians and research staff involved in data collection and statistical analysis were blinded and unaware of the randomization and intervention of the patients. 
It should be noted that capsules containing pine bark extract and placebo were identical in appearance, size, and color.</study_design>
      <phase>3</phase>
      <hc_freetext>Osteopenia.</hc_freetext>
      <i_freetext>Intervention 1: placebo, 150 mg,once daily,12 weeks. Intervention 2: Oligopin  ,150 mg ,once daily, 12 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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Data are available on request to the authors after manuscript publication.

When:
when summary data are published

To whom:
This is only available for people working

Conditions:
----

Where to obtain:
Corresponding authors' email addresses

How to obtain:
---

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Solaleh Emamgholipour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Biochemistry, Faculty of Medicine, Tehran University of Medical Sciences, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>00982164432623</zip>
        <telephone>+98 21 6443 2623</telephone>
        <email>semamgholipour@sina.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Solaleh Emamgholipour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Biochemistry, Faculty of Medicine, Tehran University of Medical Sciences, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1416634793</zip>
        <telephone>+98 21 6443 2623</telephone>
        <email>semamgholipour@sina.tums.ac.ir</email>
        <affiliation>Department of Biochemistry, Faculty of Medicine, Tehran University of Medical Sciences, Tehran, Iran</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Postmenopausal women;
Aged between 50-65;
Diagnosis of osteopenia based on Tscore ( -2.5 SD ≤ Tscore ≤ -1 SD)
To have equal physical, pediatric and complementary therapies for at least three months before entrance to study</inclusion_criteria>
      <agemin>50 years</agemin>
      <agemax>65 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>The subjects were excluded if they had body mass index ≥ 40 kg/m2, the occurrence of any visible side effects of the intervention,fracture report during the follow-up period, refusal to continue the trial, history of bone disorders, history of any malignancy, diabetes, kidney failure, hepatic disease, skeletal disorders, systemic inflammatory diseases,  rheumatologic disorders, degenerative joint diseases, hyperthyroidism, Cushing's syndrome, history of gastrointestinal disease or bleeding,  motor disabilities,  untreated psychiatric illnesses such as Alzheimer's disease, Parkinson's disease, psychosis, and current smoking and alcohol intake.As for the history of the use of drugs, women receiving osteoporosis drugs (e.g. estrogen receptor-selective agonists / antagonists, bisphosphonates, PTH, and alternative HRTs), anticonvulsants (i.e. phenobarbital, phenytoin, sodium valproate), nonsteroidal anti-inflammatory drugs (i.e. naproxen, aspirin, and ibuprofen), thiazides, diuretics, glucocorticoids were not permitted to participate in this study.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M 81.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Postmenopausal osteoporosis</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>placebo, 150 mg,once daily,12 weeks</i_keyword>
      <i_keyword>Oligopin  ,150 mg ,once daily, 12 week</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Carboxy terminal collagen type I. Timepoint: Before and third month after intervention. Method of measurement: ELISA.</prim_outcome>
      <prim_outcome>Osteocalcin. Timepoint: Before and third month after intervention. Method of measurement: ELISA.</prim_outcome>
      <prim_outcome>Osteocalcin/CTX1 ratio. Timepoint: Before and third month after interventio. Method of measurement: --.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>MnSOD activity in plasma and peripheral blood mononuclear cells (PBMCs) in postmenopausal osteopenic women and placebo-concurrent  controls. Timepoint: At first of study,third month. Method of measurement: spectrophotometer.</sec_outcome>
      <sec_outcome>Catalse activity in plasma and peripheral blood mononuclear cells (PBMCs) in postmenopausal osteopenic women and placebo-concurrent  controls. Timepoint: Before intervention,third month after intervention. Method of measurement: spectrophotometer.</sec_outcome>
      <sec_outcome>NrF2 gene expression in peripheral blood mononuclear cells (PBMCs) in postmenopausal osteopenic women and placebo-concurrent  controls. Timepoint: Before intervention,third month after intervention. Method of measurement: Real-Time PCR.</sec_outcome>
      <sec_outcome>MnSOD expression  in peripheral blood mononuclear cells (PBMCs) in postmenopausal osteopenic women and placebo-concurrent  controls. Timepoint: Before intervention,third month after intervention. Method of measurement: real-time PCR.</sec_outcome>
      <sec_outcome>Catalase expression in peripheral blood mononuclear cells (PBMCs) in postmenopausal osteopenic women and placebo-concurrent  controls. Timepoint: Before intervention,third month after intervention. Method of measurement: real-time PCR.</sec_outcome>
      <sec_outcome>MDA plasma levels in postmenopausal osteopenic women and placebo-concurrent  controls. Timepoint: Before intervention,third month after intervention. Method of measurement: spectrophotometer.</sec_outcome>
      <sec_outcome>Plasma levels of total antioxidant capacity  in postmenopausal osteopenic women and placebo-concurrent  controls. Timepoint: Before intervention,third month after intervention. Method of measurement: spectrophotometer.</sec_outcome>
      <sec_outcome>Evaluating plasma levels of protein carbonylation  in postmenopausal osteopenic women and placebo-concurrent  controlsP. Timepoint: Before intervention,third month after intervention. Method of measurement: spectrophotometer.</sec_outcome>
      <sec_outcome>Evaluating plasma levels of total thiol contents   in postmenopausal osteopenic women and placebo-concurrent  controls. Timepoint: Before intervention,third month after intervention. Method of measurement: spectrophotometer.</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-05-23</approval_date>
        <contact_name>Ethics Committee of Tehran University of Medical Sciences (TUMS)</contact_name>
        <contact_address>Tehran University of Medical Sciences (TUMS) Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
