xml: <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/NCT06035315</url>
    </required_header>
    <id_info>
      <org_study_id>23-02-0259</org_study_id>
      <nct_id>NCT06035315</nct_id>
    </id_info>
    <brief_title>The 1000 First Day of Life : Effect of Multi Micronutrients Supplementation on Pregnancy Outcomes</brief_title>
    <official_title>The 1000 First Day of Life : Effect of Multi Micronutrients Supplementation on Pregnancy Outcomes</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Dr Cipto Mangunkusumo General Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Dr Cipto Mangunkusumo General Hospital</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        To monitor the effects of multi micronutrients supplementations during pregnancy towards&#xD;
        pregnancy outcomes&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        A randomized control trial of two clusters :&#xD;
  &#xD;
        1st cluster without giving multi micronutrients; 2nd cluster giving multi micronutrients.&#xD;
  &#xD;
        Differences between cluster : Additional multi micronutrients by giving : Complete multi&#xD;
        micronutrients, calcium, vitamin D and DHA. The additional multi micronutrients were given&#xD;
        since 1st until 3rd trimester for interventions group. There are also additional laboratory&#xD;
        examinations for intervention group : Vitamin D, Lipid Profile and Zinc level.&#xD;
  &#xD;
        In control group : we use standard public health care micronutrients (Iron supplementation&#xD;
        and calcium); and standard blood examinations.&#xD;
  &#xD;
        Ultrasound examination was performed for both cluster since 1st until 3rd trimester.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">May 1, 2023</start_date>
    <completion_date type="Anticipated">August 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">May 31, 2024</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>
      <intervention_model_description>Randomized control trial : comparison of two clusters</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Maternal Outcome</measure>
      <time_frame>1 year</time_frame>
      <description>Maternal Death; Preterm Delivery; Preeclampsia; Intrauterine Infections; Post partum hemorrhage</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Perinatal Outcome</measure>
      <time_frame>1 year</time_frame>
      <description>Neonatal death; Low birth weight; Intra uterine growth restriction; Asphyxia</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">240</enrollment>
    <condition>Maternal Care Patterns</condition>
    <condition>Nutrition, Healthy</condition>
    <condition>Nutritional Deficiency</condition>
    <condition>Maternal-Fetal Relations</condition>
    <condition>Perinatal Outcome</condition>
    <condition>Maternal Outcome</condition>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Pregnant women examine since 8 weeks gestation are being followed until delivery; are given government micronutrients; and perform ultrasound examinations each trimester and regular laboratory examination.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Interventions</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Pregnant women examine since 8 weeks gestation are being followed until delivery; are given additional micronutrients (Complete multi micronutrients-Calcium-Vitamin D-DHA); and perform ultrasound examinations each trimester and additional laboratory examination (Vitamin D level-Lipid profile-Zinc)</description>
    </arm_group>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Multiple Micronutrients during pregnancy</intervention_name>
      <description>Pregnant women examine since 8 weeks gestation are being followed until delivery; are given additional micronutrients (Complete multi micronutrients-Calcium-Vitamin D-DHA); and perform ultrasound examinations each trimester and additional laboratory examination (Vitamin D level-Lipid profile-Zinc)</description>
      <arm_group_label>Interventions</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  First trimester pregnancy&#xD;
  &#xD;
            -  Gestational age &lt; 10 weeks gestation&#xD;
  &#xD;
            -  Agree as research participant&#xD;
  &#xD;
            -  Living in DKI Jakarta&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Assisted Reproductive&#xD;
  &#xD;
            -  History of PCOS&#xD;
  &#xD;
            -  History of Chronic Hypertension&#xD;
  &#xD;
            -  History of Diabetes Mellitus&#xD;
  &#xD;
            -  History of Preeclampsia&#xD;
  &#xD;
            -  Maternal chronic disease : Cardiovascular disease; Autoimmune condition; Malignancy)&#xD;
  &#xD;
            -  Plan to move from Jakarta prior or during pregnancy&#xD;
  &#xD;
            -  History of Recurrent pregnancy loss&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>15 Years</minimum_age>
      <maximum_age>45 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Yurika Elizabeth, Medical Doctor</last_name>
      <phone>+62 8999979916</phone>
      <email>yurika.elizabeth.s@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Amanda Rumondang, Obstetrician Gynecologist</last_name>
      <phone>+62 81318375211</phone>
      <email>amanda17.md@gmail.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Cipto Mangunkusumo General Hospital</name>
        <address>
          <city>Jakarta Pusat</city>
          <state>DKI Jakarta</state>
          <zip>10430</zip>
          <country>Indonesia</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Rima Irwinda, PhD</last_name>
        <phone>+62 812-9044-604</phone>
        <email>rima.irwinda@yahoo.com</email>
      </contact>
      <contact_backup>
        <last_name>Amanda Rumondang, Obstetrician Gynecologist</last_name>
        <phone>+62 813 18375211</phone>
        <email>amanda17.md@gmail.com</email>
      </contact_backup>
    </location>
    <location>
      <facility>
        <name>Cipto Mangunkusumo General Hospital</name>
        <address>
          <city>Jakarta</city>
          <zip>10430</zip>
          <country>Indonesia</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Rima Irwinda, PhD</last_name>
        <phone>+62 812-9044-604</phone>
        <email>rima.irwinda@yahoo.com</email>
      </contact>
      <contact_backup>
        <last_name>Amanda Rumondang, Obstetricians Gynecologist</last_name>
        <phone>+62 81318375211</phone>
        <email>amanda17.md@gmail.com</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>Indonesia</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 6, 2023</study_first_submitted>
    <study_first_submitted_qc>September 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Dr Cipto Mangunkusumo General Hospital</investigator_affiliation>
      <investigator_full_name>Rima Irwinda</investigator_full_name>
      <investigator_title>MD, OBGYN, PhD</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Malnutrition</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Micronutrients</mesh_term>
      <mesh_term>Trace Elements</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06035315
  org study id: 23-02-0259
  nct id: NCT06035315
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  To monitor the effects of multi micronutrients supplementations during pregnancy towards
        pregnancy outcomes
  A randomized control trial of two clusters :
  
        1st cluster without giving multi micronutrients; 2nd cluster giving multi micronutrients.
  
        Differences between cluster : Additional multi micronutrients by giving : Complete multi
        micronutrients, calcium, vitamin D and DHA. The additional multi micronutrients were given
        since 1st until 3rd trimester for interventions group. There are also additional laboratory
        examinations for intervention group : Vitamin D, Lipid Profile and Zinc level.
  
        In control group : we use standard public health care micronutrients (Iron supplementation
        and calcium); and standard blood examinations.
  
        Ultrasound examination was performed for both cluster since 1st until 3rd trimester.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Randomized control trial : comparison of two clusters
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Maternal Outcome
  time frame: 1 year
  description: Maternal Death; Preterm Delivery; Preeclampsia; Intrauterine Infections; Post partum hemorrhage
  measure: Perinatal Outcome
  time frame: 1 year
  description: Neonatal death; Low birth weight; Intra uterine growth restriction; Asphyxia
  arm group label: Control
  arm group type: No Intervention
  description: Pregnant women examine since 8 weeks gestation are being followed until delivery; are given government micronutrients; and perform ultrasound examinations each trimester and regular laboratory examination.
  arm group label: Interventions
  arm group type: Active Comparator
  description: Pregnant women examine since 8 weeks gestation are being followed until delivery; are given additional micronutrients (Complete multi micronutrients-Calcium-Vitamin D-DHA); and perform ultrasound examinations each trimester and additional laboratory examination (Vitamin D level-Lipid profile-Zinc)
  intervention type: Dietary Supplement
  intervention name: Multiple Micronutrients during pregnancy
  description: Pregnant women examine since 8 weeks gestation are being followed until delivery; are given additional micronutrients (Complete multi micronutrients-Calcium-Vitamin D-DHA); and perform ultrasound examinations each trimester and additional laboratory examination (Vitamin D level-Lipid profile-Zinc)
  arm group label: Interventions
  criteria: 
  gender: Female
  minimum age: 15 Years
  maximum age: 45 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Yurika Elizabeth, Medical Doctor
  phone: +62 8999979916
  email: yurika.elizabeth.s@gmail.com
  last name: Amanda Rumondang, Obstetrician Gynecologist
  phone: +62 81318375211
  email: amanda17.md@gmail.com
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: Indonesia
  responsible party type: Principal Investigator
  investigator affiliation: Dr Cipto Mangunkusumo General Hospital
  investigator full name: Rima Irwinda
  investigator title: MD, OBGYN, PhD
  mesh term: Malnutrition
  mesh term: Micronutrients
  mesh term: Trace Elements
  sharing ipd: No