<?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>IRCT20110425006284N15</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-03-14</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>The effect of education based on planned behavioral model in vitamin D supplement taking in lactating women</public_title>
      <acronym></acronym>
      <scientific_title>The effect of education based on planned behavioral model in vitamin D supplement taking in lactating women.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-07-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/35908</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Crossover, Purpose: Education/Guidance, Randomization description: First, the total vitamin D levels of women entering the study will be measured. Women with a serum concentration of vitamin D of less than 30 will be studied and then divided into two groups by random block method.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Lactating women.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In the intervention group, a researcher-made questionnaire (including questions: knowledge, attitude, abstract norms, behavioral control, and behavioral intention) should be completed by nursing mothers. Then, vitamin D will be prescribed by the local specialist in the clinic based on the scientific method, depending on the deficiency.1-Serum Hydroxyvitamin D is less than 10 ng / ml: 50,000 units of vitamin D2 or D3, orally once a week for 6 to 8 weeks, and then 800 units of vitamin D3 per day.2. Serum vitamin D concentration greater than 10 and less than 20 ng / ml: 800 to 1000 units per day followed by follow up after three months.3. Serum concentrations of vitamin D of 20 and less than 30 ng / ml: 600 to 800 units of vitamin D3 are sufficient to maintain the levels of 25 hydroxyvitamin D in the target.Also, training based on the planned behavior of the model in 4 sessions, one week in face to face will be held as follows. At the first meeting, the group will discuss the experiences of friends and other people familiar with the use of vitamin D supplementation. The discussion and exchange of thoughts will be guided by the trainer to identify positive attitudes and beliefs that will guide people in giving people a positive impulse for taking vitamin D tablets and creating new attitudes and improving the negative attitude toward taking vitamin D, which lasts for 30 minutes Will take. In the second training session, considering the unpreparedness and emotionality obtained during the first session, along with the abstract norms that affect the use of vitamin D, vitamin D and its nutritional supplementation will be explained by the presentation of educational slides, and will seek to further motivate the necessity Vitamin D will be consumed during lactation, and thereafter, discussions will be held on the use of different types of foods and foods containing vitamin D among women, as well as misconceptions about the use of vitamin D tablets. Will reduce the intensity of these misconceptions and prepare the ground for a change of attitude and a new belief. In this meeting, a family member or close friend who will have a great impact on the person will be invited to attend the meeting. The second session will take up to 30 minutes. The third session of the training will focus on the determination of taking action on taking vitamin D tablets by providing solutions that will be thought through by the research itself. This session will end with a cohort of behavioral mediation that will take 30 minutes. The fourth session will focus on the maternal and infant deficiencies in vitro D and the benefits of vitamin D supplementation for mother and baby and the intention of the mother to take vitamin D by slideshows and teaching methods for lectures, questions and answers, and sentimental thoughts like all other sessions. The duration of the meeting will be 30 minutes. At the end of each training session, research units will be reminded if they have questions in the field of knowledge of the researcher. At the end of the fourth session of the educational pamphlet, a training pamphlet will include information and training on vitamin D, vitamin D products, and Vitamin D-containing foods will be given to the intervention group, followed by a three-week phone call within 3 months. After three months, the level of vitamin D was measured and a researcher-made questionnaire including knowledge, attitude, abstract norms, behavioral control, and behavioral intention intentionally measured and pre-intervention using T-test, t-test, paired t-test, chi square test, Mann-Whitney test And the Wilcoxon test will be compared. Intervention 2: Control group: At first, knowledge, attitude, abstract norms, behavioral control, and behavioral intention were measured by a researcher-made questionnaire. Then, vitamin D will be administered according to the routine clinic, which is a pill, and will not be given.  After three months, the level of vitamin D, knowledge, attitude, abnormal norms, behavioral control and rehearsal intention will be measured and compared with before three months using t-test, paired t-test, chi square test, Mann-Whitney test and Wilcoxon test.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is Is still studying.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Maryam modarres</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran - Tohid Maidan - East Nusrat Street</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733171</zip>
        <telephone>+98 66933600021</telephone>
        <email>baharehfaraji.tums@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Maryam Modarres</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing &amp; Midwifery, Tehran, Tohid square,</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733171</zip>
        <telephone>+98 21 4471 7330</telephone>
        <email>modarres@sina.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Reading and writing literacy 
Married females
Physical well-being and the absence of specific disease (such as kidney disease, liver, heart, heart disease)
No use of glycosylated cardiac drugs, thiazide diuretics, phenobarbital, Technical Tween
Having an infant
Willing to participate</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Pregnancy
Absence from more than one session at training sessions
Unwillingness to cooperate
Kidney or liver disease
Immigration outside the city</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>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In the intervention group, a researcher-made questionnaire (including questions: knowledge, attitude, abstract norms, behavioral control, and behavioral intention) should be completed by nursing mothers. Then, vitamin D will be prescribed by the local specialist in the clinic based on the scientific method, depending on the deficiency.1-Serum Hydroxyvitamin D is less than 10 ng / ml: 50,000 units of vitamin D2 or D3, orally once a week for 6 to 8 weeks, and then 800 units of vitamin D3 per day.2. Serum vitamin D concentration greater than 10 and less than 20 ng / ml: 800 to 1000 units per day followed by follow up after three months.3. Serum concentrations of vitamin D of 20 and less than 30 ng / ml: 600 to 800 units of vitamin D3 are sufficient to maintain the levels of 25 hydroxyvitamin D in the target.Also, training based on the planned behavior of the model in 4 sessions, one week in face to face will be held as follows. At the first meeting, the group will discuss the experiences of friends and other people familiar with the use of vitamin D supplementation. The discussion and exchange of thoughts will be guided by the trainer to identify positive attitudes and beliefs that will guide people in giving people a positive impulse for taking vitamin D tablets and creating new attitudes and improving the negative attitude toward taking vitamin D, which lasts for 30 minutes Will take. In the second training session, considering the unpreparedness and emotionality obtained during the first session, along with the abstract norms that affect the use of vitamin D, vitamin D and its nutritional supplementation will be explained by the presentation of educational slides, and will seek to further motivate the necessity Vitamin D will be consumed during lactation, and thereafter, discussions will be held on the use of different types of foods and foods containing vitamin D among women, as well as misconceptions about the use of vitamin D tablets. Will reduce the intensity of these misconceptions and prepare the ground for a change of attitude and a new belief. In this meeting, a family member or close friend who will have a great impact on the person will be invited to attend the meeting. The second session will take up to 30 minutes. The third session of the training will focus on the determination of taking action on taking vitamin D tablets by providing solutions that will be thought through by the research itself. This session will end with a cohort of behavioral mediation that will take 30 minutes. The fourth session will focus on the maternal and infant deficiencies in vitro D and the benefits of vitamin D supplementation for mother and baby and the intention of the mother to take vitamin D by slideshows and teaching methods for lectures, questions and answers, and sentimental thoughts like all other sessions. The duration of the meeting will be 30 minutes. At the end of each training session, research units will be reminded if they have questions in the field of knowledge of the researcher. At the end of the fourth session of the educational pamphlet, a training pamphlet will include information and training on vitamin D, vitamin D products, and Vitamin D-containing foods will be given to the intervention group, followed by a three-week phone call within 3 months. After three months, the level of vitamin D was measured and a researcher-made questionnaire including knowledge, attitude, abstract norms, behavioral control, and behavioral intention intentionally measured and pre-intervention using T-test, t-test, paired t-test, chi square test, Mann-Whitney test And the Wilcoxon test will be compared.</i_keyword>
      <i_keyword>Control group: At first, knowledge, attitude, abstract norms, behavioral control, and behavioral intention were measured by a researcher-made questionnaire. Then, vitamin D will be administered according to the routine clinic, which is a pill, and will not be given.  After three months, the level of vitamin D, knowledge, attitude, abnormal norms, behavioral control and rehearsal intention will be measured and compared with before three months using t-test, paired t-test, chi square test, Mann-Whitney test and Wilcoxon test.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The number of lactating women with vitamin D is less than 30. Timepoint: The beginning of the study (before the intervention) and three months after taking vitamin D and training. Method of measurement: Serum vitamin D measurement by the laboratory and completion of a researcher-made questionnaire based on the planned behavioral pattern of vitamin D.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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>2018-06-11</approval_date>
        <contact_name>Ethics committee of Tehran University of Medical Sciences Faculty of Nursing and Midwifery and Rehab</contact_name>
        <contact_address>Tehran, Tohid Square, Dr. Mirkhani St. (East Nursing) Nursing Midwifery Faculty Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
