<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/NCT03268733</url>
  </required_header>
  <id_info>
    <org_study_id>Folic acid in PCOS</org_study_id>
    <nct_id>NCT03268733</nct_id>
  </id_info>
  <brief_title>The Effects of Folic Acid on Sudanese Women With Polycystic Ovary Syndrome</brief_title>
  <acronym>FolicacidPCOS</acronym>
  <official_title>The Clinical and Biochemical Effects of Folic Acid on Sudanese Women With Polycystic Ovary Syndrome (PCOS)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Khartoum</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Awad, Mohamed Ibrahim, M.D.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Duria abdulwahab Elrrayes</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Khartoum</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>
      An open clinical trial&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The patients with PCOS will be recruited to receive folic acid (45 patients) and equal number&#xD;
      will receive no folic acid&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">September 1, 2017</start_date>
  <completion_date type="Anticipated">September 1, 2019</completion_date>
  <primary_completion_date type="Anticipated">September 1, 2018</primary_completion_date>
  <phase>Phase 1/Phase 2</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>
    <intervention_model_description>Open trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>pregnancy rates</measure>
    <time_frame>3 months</time_frame>
    <description>Pregnancy rates will be compared in the treatment group and control group</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Ovulatory pattern improvements</measure>
    <time_frame>3 months</time_frame>
    <description>Ovulatory pattern will be assessed based on the history of the PCOS patients, the patients whom were having baseline oligomenorrhea or amenorrhea will be re-assessed for resuming regular cycles defined as periods lasting 22 - 35 days. this pattern improvement will be compared in the treatment group and control group using questionnaire</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Clinical signs of hyperandrogenemia</measure>
    <time_frame>3 months</time_frame>
    <description>Hirsutism will be used as a sign of hyperandrogenemia, Patients will be provided with modified Ferriman -Gallwey (mFG) images to self-rate hair growth in each of the 9 body areas (upper lip, chin, chest, upper and lower back, upper and lower abdomen, thighs, and upper arms). For each site, a score on a scale of 0 to 4 was recorded. A total score of 8 or greater is defined as clinical evidence of hirsutism; scores from 8 to 15 are considered mild hirsutism; scores from16 to 25 are considered moderate; and scores from 26 to 36 are considered severe hirsutism. The baseline and after 3 months hirsutism compared in the treatment group and control group</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Plasma level of testosterone</measure>
    <time_frame>3 months</time_frame>
    <description>Plasma level of testosterone will be compared in the treatment group and control group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma level of insulin</measure>
    <time_frame>3 months</time_frame>
    <description>Plasma level of insulin will be compared in the treatment group and control group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma level of follicle-stimulating hormone (FSH)</measure>
    <time_frame>3 months</time_frame>
    <description>Plasma level of follicle-stimulating hormone will be compared in the treatment group and control group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma level of luteinizing hormone (LH)</measure>
    <time_frame>3 months</time_frame>
    <description>Plasma level of luteinizing hormone will be compared in the treatment group and control group</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Lipid profile</measure>
    <time_frame>3 months</time_frame>
    <description>Lipid profile will be compared in the treatment group and control group</description>
  </other_outcome>
  <other_outcome>
    <measure>Plasma level of random glucose</measure>
    <time_frame>3 months</time_frame>
    <description>Plasma level of random glucose will be compared in the treatment group and control group</description>
  </other_outcome>
  <other_outcome>
    <measure>Plasma level of folate</measure>
    <time_frame>3 months</time_frame>
    <description>Plasma level of folate will be compared in the treatment group and control group</description>
  </other_outcome>
  <other_outcome>
    <measure>Plasma level of homocysteine (Hcy)</measure>
    <time_frame>3 months</time_frame>
    <description>Plasma level of homocysteine (Hcy) will be compared in the treatment group and control group</description>
  </other_outcome>
  <other_outcome>
    <measure>Plasma level of hemoglobin (Hb)</measure>
    <time_frame>3 months</time_frame>
    <description>Plasma level of hemoglobin (Hb) will be compared in the treatment group and control group</description>
  </other_outcome>
  <other_outcome>
    <measure>Plasma level of C-reactive protein (CRP)</measure>
    <time_frame>3 months</time_frame>
    <description>Plasma level of C-reactive protein (CRP) will be compared in the treatment group and control group</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">90</enrollment>
  <condition>Polycystic Ovary Syndrome</condition>
  <arm_group>
    <arm_group_label>Treatment group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>45 PCOS patients will receive 5 mg folic acid</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>45 PCOS patients will receive no folic acid</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Folic Acid</intervention_name>
    <description>Tablet 5 mg</description>
    <arm_group_label>Treatment group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who will visit this centre suffering from PCOS-related subfertility will be&#xD;
             invited to be enrolled to this study if met the Rotterdam criteria for the diagnosis&#xD;
             of PCOS&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The patients whom will be excluded from the study are those comorbid with&#xD;
             hyperprolactinemia, congenital adrenal hyperplasia, diabetes mellitus, significant&#xD;
             cardiovascular problems, thyroid dysfunctions, unresolved medical conditions, or using&#xD;
             medications suspected to affect reproductive or metabolic functions within two months&#xD;
             of the study entry.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>female patients suffering from PCOS-related subfertility</gender_description>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mohammed Hassan Alnazeer</last_name>
    <role>Study Chair</role>
    <affiliation>University of Khartoum</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Mohammed Hassan Alnazeer</last_name>
    <phone>00249912907268</phone>
    <email>mhmd_nazir83@yahoo.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Saad Abul ella fertility Centre</name>
      <address>
        <city>Khartoum</city>
        <zip>11111</zip>
        <country>Sudan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mohammed ibrahim Awad</last_name>
      <phone>00249900904060</phone>
      <email>awad22mohd@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Sudan</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 24, 2017</study_first_submitted>
  <study_first_submitted_qc>August 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 31, 2017</study_first_posted>
  <last_update_submitted>August 28, 2017</last_update_submitted>
  <last_update_submitted_qc>August 28, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 31, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Khartoum</investigator_affiliation>
    <investigator_full_name>Mohammed Hassan Alnazeer</investigator_full_name>
    <investigator_title>Clinical Pharmacist</investigator_title>
  </responsible_party>
  <keyword>Folic acid</keyword>
  <keyword>PCOS</keyword>
  <keyword>Insulin resistance</keyword>
  <keyword>Infertility</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Polycystic Ovary Syndrome</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Folic Acid</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>still undecided</ipd_description>
  </patient_data>
  <!-- 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/NCT03268733
org study id: Folic acid in PCOS
nct id: NCT03268733
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
An open clinical trial
The patients with PCOS will be recruited to receive folic acid (45 patients) and equal number
      will receive no folic acid
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Open trial
primary purpose: Treatment
masking: None (Open Label)
measure: pregnancy rates
time frame: 3 months
description: Pregnancy rates will be compared in the treatment group and control group
measure: Ovulatory pattern improvements
time frame: 3 months
description: Ovulatory pattern will be assessed based on the history of the PCOS patients, the patients whom were having baseline oligomenorrhea or amenorrhea will be re-assessed for resuming regular cycles defined as periods lasting 22 - 35 days. this pattern improvement will be compared in the treatment group and control group using questionnaire
measure: Clinical signs of hyperandrogenemia
time frame: 3 months
description: Hirsutism will be used as a sign of hyperandrogenemia, Patients will be provided with modified Ferriman -Gallwey (mFG) images to self-rate hair growth in each of the 9 body areas (upper lip, chin, chest, upper and lower back, upper and lower abdomen, thighs, and upper arms). For each site, a score on a scale of 0 to 4 was recorded. A total score of 8 or greater is defined as clinical evidence of hirsutism; scores from 8 to 15 are considered mild hirsutism; scores from16 to 25 are considered moderate; and scores from 26 to 36 are considered severe hirsutism. The baseline and after 3 months hirsutism compared in the treatment group and control group
measure: Plasma level of testosterone
time frame: 3 months
description: Plasma level of testosterone will be compared in the treatment group and control group
measure: Plasma level of insulin
time frame: 3 months
description: Plasma level of insulin will be compared in the treatment group and control group
measure: Plasma level of follicle-stimulating hormone (FSH)
time frame: 3 months
description: Plasma level of follicle-stimulating hormone will be compared in the treatment group and control group
measure: Plasma level of luteinizing hormone (LH)
time frame: 3 months
description: Plasma level of luteinizing hormone will be compared in the treatment group and control group
measure: Lipid profile
time frame: 3 months
description: Lipid profile will be compared in the treatment group and control group
measure: Plasma level of random glucose
time frame: 3 months
description: Plasma level of random glucose will be compared in the treatment group and control group
measure: Plasma level of folate
time frame: 3 months
description: Plasma level of folate will be compared in the treatment group and control group
measure: Plasma level of homocysteine (Hcy)
time frame: 3 months
description: Plasma level of homocysteine (Hcy) will be compared in the treatment group and control group
measure: Plasma level of hemoglobin (Hb)
time frame: 3 months
description: Plasma level of hemoglobin (Hb) will be compared in the treatment group and control group
measure: Plasma level of C-reactive protein (CRP)
time frame: 3 months
description: Plasma level of C-reactive protein (CRP) will be compared in the treatment group and control group
arm group label: Treatment group
arm group type: Experimental
description: 45 PCOS patients will receive 5 mg folic acid
arm group label: control group
arm group type: No Intervention
description: 45 PCOS patients will receive no folic acid
intervention type: Drug
intervention name: Folic Acid
description: Tablet 5 mg
arm group label: Treatment group
criteria: 
gender: Female
gender based: Yes
gender description: female patients suffering from PCOS-related subfertility
minimum age: 20 Years
maximum age: 40 Years
healthy volunteers: No
last name: Mohammed Hassan Alnazeer
role: Study Chair
affiliation: University of Khartoum
last name: Mohammed Hassan Alnazeer
phone: 00249912907268
email: mhmd_nazir83@yahoo.com
facility: 
status: Recruiting
contact: 
country: Sudan
responsible party type: Principal Investigator
investigator affiliation: University of Khartoum
investigator full name: Mohammed Hassan Alnazeer
investigator title: Clinical Pharmacist
mesh term: Polycystic Ovary Syndrome
mesh term: Syndrome
mesh term: Folic Acid
sharing ipd: Undecided
ipd description: still undecided