<?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>IRCT20211105052972N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-12-04</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>Effects of tolerable high dose of Vitamin B12, B6 &amp; Folate intake on Behavioral and psychological symptoms &amp; Quality of life in patients with Alzheimer's disease</public_title>
      <acronym></acronym>
      <scientific_title>Effects of tolerable high dose of Vitamin B12, B6 &amp; Folate intake on Behavioral and psychological symptoms &amp; Quality of life in patients with Alzheimer's disease</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-12-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/59806</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: A total number of 60 Alzheimer’s type dementia eligible according to the included criteria and filled the informed consent (themselves or a family member)  randomly divided into two interventions (n=30) and a control group (n=30) with Block randomization of two treatment groups A and B, number of blocks = 6, size of blocks = 10, and fixed-size blocks. C the Sequentially numbered, opaque, sealed envelope (SNOSE) technique is for Concealment of allocation. sealed envelopes are the randomization tools, Blinding description: All drugs (placebo and intervention)  in both groups are double-blinded and similar in color, size, and shape. neither the participant nor the investigator, caregivers, data collectors, and outcome assessor is aware of the treatment allotted.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Alzheimer’s disease with late onset: Onset usually after the age of 65.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group (n=30):  each patient takes 3 tablets daily from their caregivers ( 40 mg Tablet of Vitamin B6,  1mg tablet of Vitamin B9, and  1mg tablet of Vitamin B12) after the meal with a glass of water for two months. according to ethical problems, In the intervention and control groups,  patients receive similar standard main AD medicines. Intervention 2: Control group (n=30): each patient takes 3 placebo tablets from their caregivers daily (shape, size, and color-matched with the case group) right after the meal with a glass of water for 2 months.</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 There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohsen Nemati</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Nutrition, School of Medicine, Mashhad university of medical sciences</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>91779-48564</zip>
        <telephone>+98 51 3800 2361</telephone>
        <email>NematyM@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ali Shoeibi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Neurology Department - Minus One- Ghaem Hospital - Ahmad Abad Ave - Mashhad</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>99199-91766</zip>
        <telephone>+98 51 3842 9828</telephone>
        <email>shoeibia@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Alzheimer’s type dementia (DSM-IV, mild and moderate MMSE score=12-24, Age ≥65)
no mentioned past medical history of cardiovascular disease (heart attack, arrhythmia, any heart surgery, and PCI implantation), severe renal disease (Cl Cr. &gt;30 ml/min), seizure, anemia or vitamin B deficiency, and diabetes mellitus ( FBS&lt;126 mg/dl).
the patient should not have any recorded family history of cardiovascular disease, Parkinson's disease, or any other psychological or neurological disorder.
The patient recording must be free of alcohol or any substance abuse and vitamin B interactive drugs at least one month before starting the trial.
each Patient should have a certain caregiver (a Nurse - a family member).</inclusion_criteria>
      <agemin>65 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients are excluded if they miss the interventions for more than 7 days.
death by natural causes.
voluntary exclusion.
patients with reported severe side effects of vitamin B during the trial. ( vitamin B6 neurotoxicity, arrhythmia, ataxia, nausea, diarrhea, skin rash, abdominal discomfort, drowsiness seizure, and severe depression)</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G30.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Alzheimer’s disease with late onset: Onset usually after the age of 65</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group (n=30):  each patient takes 3 tablets daily from their caregivers ( 40 mg Tablet of Vitamin B6,  1mg tablet of Vitamin B9, and  1mg tablet of Vitamin B12) after the meal with a glass of water for two months. according to ethical problems, In the intervention and control groups,  patients receive similar standard main AD medicines.</i_keyword>
      <i_keyword>Control group (n=30): each patient takes 3 placebo tablets from their caregivers daily (shape, size, and color-matched with the case group) right after the meal with a glass of water for 2 months.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Cognitive symptoms. Timepoint: before intervention and 8 weeks after intervention. Method of measurement: MMSE score (Questionnaire) and MoCA test (Questionnaire)/.</prim_outcome>
      <prim_outcome>BPSD(Behavioral and psychological symptoms of dementia). Timepoint: before intervention and 8 weeks after intervention. Method of measurement: NPI test(Questionnaire).</prim_outcome>
      <prim_outcome>Quality of life. Timepoint: before intervention and 8 weeks after intervention. Method of measurement: QOL-AD test (Questionnaire).</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>Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-10-27</approval_date>
        <contact_name>Research Ethics committee of school of medicine-Mashhad University of Medical Sciences</contact_name>
        <contact_address>Khorasan Razavi, Mashhad, University Street - next to Hoveyzeh Cinema - Ghorashi Building - Deputy of Research and Technology Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
