<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03754712</url>
  </required_header>
  <id_info>
    <org_study_id>No. BSMMU /2018/2964</org_study_id>
    <nct_id>NCT03754712</nct_id>
  </id_info>
  <brief_title>Effect of Vitamin D Administration Along With SSRIs in Patients With Major Depressive Disorder</brief_title>
  <official_title>Effect of Vitamin D Administration Along With Selective Serotonin Reuptake Inhibitors (SSRIs) in Patients With Major Depressive Disorder (MDD)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Several studies suggested low serum levels of vitamin D have been associated with depression.&#xD;
      So, the present study is designed to investigate the effect of vitamin D administration along&#xD;
      with SSRIs in patients with MDD.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Depression is a major global health problem. Major depression was ranked as the third leading&#xD;
      cause of the global burden of diseases in 2004 and is supposed to occupy the first place by&#xD;
      2030. Major depression is a complex and multifactorial symptom-complex while dysfunctions in&#xD;
      various endocrine axes may be independent risk factors in the development of the affective&#xD;
      illness. Some recent observations indicate a significant role of vitamin D regarding mood.&#xD;
      Vitamin D3 receptors have been found in cerebral cortex, cerebellum, and the limbic system.&#xD;
      The active form of vitamin D on the nervous system is associated with modifying the&#xD;
      production and release of neurotrophic factors such as nerve growth factor (NGF) which is&#xD;
      essential for neuron differentiation, as well as increasing the levels of glial cell line&#xD;
      derived neurotrophic factor (GDNF). Vitamin D influence the expression of genes associated&#xD;
      GABA-ergic neurotransmission. It also stimulates the expression of tyrosine hydroxylase which&#xD;
      is responsible for catecholamines biosynthesis. Lately, positive influences of vitamin D upon&#xD;
      patients suffering from MDD have been suggested. This area require further attention and&#xD;
      confirmation as little work has been carried out in this field. So, the present study is an&#xD;
      attempt to investigate the effect of vitamin D administration along with SSRIs in patients&#xD;
      with MDD. The study would be a interventional one to be conducted in the department of&#xD;
      Pharmacology and in the department of psychiatry, BSMMU. A total of 90 patients suffering&#xD;
      from major depression will be selected according to inclusion and exclusion criteria. The&#xD;
      diagnosis of patients suffering from major depression and the selection of SSRIs would be&#xD;
      performed by medical officer of the Psychiatry department. After completing necessary&#xD;
      formalities including informed consent of the patients, patient's data will be collected to&#xD;
      measure baseline complaints of depression. The patients would be divided into two groups:&#xD;
      group A and B. Group A would consist of 45 patients who will receive only SSRIs and Group B&#xD;
      would consist of 45 patients who will receive SSRIs plus vitamin D (2000IU) orally once&#xD;
      daily. Blood sample will be collected to measure serum vitamin D and calcium level at&#xD;
      baseline. Then again blood sample will be collected to measure serum vitamin D level after 8&#xD;
      weeks of vitamin D administration. Regularity of medicine intake will be ensured over&#xD;
      telephone, pill count, and from the patient's compliance sheet. The study has entails almost&#xD;
      no potential risk to the patients. Patients would have every right to quit the experimental&#xD;
      procedure any time during the experimentations if they desire each. However, it will be&#xD;
      explained to them that the results of the present study may offer better prospects for&#xD;
      similar patients in future, and that the present experimentations would carry no potential&#xD;
      risk towards their health or their lives provided they strictly follow the instructions&#xD;
      conducted to them.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">March 10, 2018</start_date>
  <completion_date type="Anticipated">February 28, 2019</completion_date>
  <primary_completion_date type="Anticipated">January 10, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Severity of depression</measure>
    <time_frame>8 weeks</time_frame>
    <description>Changes in severity of depression will be measured through the Patient Health Questionnaire - 9 (PHQ - 9) score at baseline and at 8 weeks</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">90</enrollment>
  <condition>MDD</condition>
  <arm_group>
    <arm_group_label>Intervention Vitamin D3 along with SSRIs</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>One tablet of vitamin D3 (2000IU) per day for 8 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SSRIs</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients treated with SSRIs</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Vitamin D3</intervention_name>
    <description>Dietary supplement : Vitamin D3 one tablet of vitamin D3 (2000IU) per day for 8 weeks</description>
    <arm_group_label>Intervention Vitamin D3 along with SSRIs</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients with MDD&#xD;
&#xD;
          -  patients with PHQ - 9 score more than 10&#xD;
&#xD;
          -  serum vitamin D less than 30 ng/ml&#xD;
&#xD;
          -  Serum calcium level 8.5-10.5 mg/dl&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients receiving antidepressant and dietary supplement with in last two months.&#xD;
&#xD;
          -  Patients with other psychological disorder ( such as schizophrenia, bipolar affective&#xD;
             disorder)&#xD;
&#xD;
          -  Patients with parathyroid disease, thyroid disease, liver and kidney disease&#xD;
&#xD;
          -  Patients with Diabetes mellitus&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Tanzina Afrin, MBBS</last_name>
    <phone>01796372338</phone>
    <email>Tanzina.afrin800@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Sultanul Arifin, MBBS</last_name>
    <phone>01723836535</phone>
    <email>Sam35th@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>BSMMU</name>
      <address>
        <city>Dhaka</city>
        <country>Bangladesh</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tanzina Afrin, MBBS</last_name>
      <phone>01796372338</phone>
      <email>Tanzina.afrin800@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Sultanul Arifin, MBBS</last_name>
      <phone>01723836535</phone>
      <email>Sam35th@gmail.com</email>
    </contact_backup>
    <investigator>
      <last_name>Tanzina Afrin, MBBS</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Bangladesh</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 25, 2018</study_first_submitted>
  <study_first_submitted_qc>November 25, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 27, 2018</study_first_posted>
  <last_update_submitted>November 27, 2018</last_update_submitted>
  <last_update_submitted_qc>November 27, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 28, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh</investigator_affiliation>
    <investigator_full_name>Tanzina Afrin</investigator_full_name>
    <investigator_title>MD, Resident</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depressive Disorder</mesh_term>
    <mesh_term>Depressive Disorder, Major</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vitamin D</mesh_term>
    <mesh_term>Cholecalciferol</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03754712
org study id: No. BSMMU /2018/2964
nct id: NCT03754712
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Several studies suggested low serum levels of vitamin D have been associated with depression.
      So, the present study is designed to investigate the effect of vitamin D administration along
      with SSRIs in patients with MDD.
Depression is a major global health problem. Major depression was ranked as the third leading
      cause of the global burden of diseases in 2004 and is supposed to occupy the first place by
      2030. Major depression is a complex and multifactorial symptom-complex while dysfunctions in
      various endocrine axes may be independent risk factors in the development of the affective
      illness. Some recent observations indicate a significant role of vitamin D regarding mood.
      Vitamin D3 receptors have been found in cerebral cortex, cerebellum, and the limbic system.
      The active form of vitamin D on the nervous system is associated with modifying the
      production and release of neurotrophic factors such as nerve growth factor (NGF) which is
      essential for neuron differentiation, as well as increasing the levels of glial cell line
      derived neurotrophic factor (GDNF). Vitamin D influence the expression of genes associated
      GABA-ergic neurotransmission. It also stimulates the expression of tyrosine hydroxylase which
      is responsible for catecholamines biosynthesis. Lately, positive influences of vitamin D upon
      patients suffering from MDD have been suggested. This area require further attention and
      confirmation as little work has been carried out in this field. So, the present study is an
      attempt to investigate the effect of vitamin D administration along with SSRIs in patients
      with MDD. The study would be a interventional one to be conducted in the department of
      Pharmacology and in the department of psychiatry, BSMMU. A total of 90 patients suffering
      from major depression will be selected according to inclusion and exclusion criteria. The
      diagnosis of patients suffering from major depression and the selection of SSRIs would be
      performed by medical officer of the Psychiatry department. After completing necessary
      formalities including informed consent of the patients, patient's data will be collected to
      measure baseline complaints of depression. The patients would be divided into two groups:
      group A and B. Group A would consist of 45 patients who will receive only SSRIs and Group B
      would consist of 45 patients who will receive SSRIs plus vitamin D (2000IU) orally once
      daily. Blood sample will be collected to measure serum vitamin D and calcium level at
      baseline. Then again blood sample will be collected to measure serum vitamin D level after 8
      weeks of vitamin D administration. Regularity of medicine intake will be ensured over
      telephone, pill count, and from the patient's compliance sheet. The study has entails almost
      no potential risk to the patients. Patients would have every right to quit the experimental
      procedure any time during the experimentations if they desire each. However, it will be
      explained to them that the results of the present study may offer better prospects for
      similar patients in future, and that the present experimentations would carry no potential
      risk towards their health or their lives provided they strictly follow the instructions
      conducted to them.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Severity of depression
time frame: 8 weeks
description: Changes in severity of depression will be measured through the Patient Health Questionnaire - 9 (PHQ - 9) score at baseline and at 8 weeks
arm group label: Intervention Vitamin D3 along with SSRIs
arm group type: Active Comparator
description: One tablet of vitamin D3 (2000IU) per day for 8 weeks
arm group label: SSRIs
arm group type: No Intervention
description: Patients treated with SSRIs
intervention type: Dietary Supplement
intervention name: Vitamin D3
description: Dietary supplement : Vitamin D3 one tablet of vitamin D3 (2000IU) per day for 8 weeks
arm group label: Intervention Vitamin D3 along with SSRIs
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Tanzina Afrin, MBBS
phone: 01796372338
email: Tanzina.afrin800@gmail.com
last name: Sultanul Arifin, MBBS
phone: 01723836535
email: Sam35th@gmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: Bangladesh
responsible party type: Principal Investigator
investigator affiliation: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
investigator full name: Tanzina Afrin
investigator title: MD, Resident
mesh term: Depressive Disorder
mesh term: Depressive Disorder, Major
mesh term: Vitamin D
mesh term: Cholecalciferol