<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/NCT01660165</url>
  </required_header>
  <id_info>
    <org_study_id>CAAE 0139.0.314.000-09</org_study_id>
    <nct_id>NCT01660165</nct_id>
  </id_info>
  <brief_title>Nutritional Status and Mental Health During Pregnancy and Postpartum: a Cohort Study in Rio de Janeiro, Brazil</brief_title>
  <official_title>Mental Health and Nutritional Status During Pregnancy and Postpartum: A Prospective Study With a Nested Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidade Federal do Rio de Janeiro</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidade Federal do Rio de Janeiro</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      There is increasing evidence that psychosocial factors may affect health by means of&#xD;
      biological effects and changes in behavioral health. Observational studies suggest an&#xD;
      association between low levels of one long chain n-3 fatty acids, DHA (docosahexaenoic acid),&#xD;
      after pregnancy and the occurrence of postpartum depression (PPD). This is an observational&#xD;
      cohort with 4 waves of follow-up and a nested clinical trial with pregnant women residing in&#xD;
      the city of Rio de Janeiro. The general objective is to describe the magnitude and identify&#xD;
      factors associated to common mental disorders (CMD) during pregnancy and postpartum giving&#xD;
      emphasis to maternal nutritional status.&#xD;
&#xD;
      Main specific objectives:&#xD;
&#xD;
        1. To evaluate the effect of CMD in the pattern of occurrence of selected maternal and&#xD;
           child outcomes (inadequacy of gestational weight gain, postpartum weight retention, low&#xD;
           birthweight, small for gestational weight and prematurity), considering the effect of&#xD;
           other determinant factors, and&#xD;
&#xD;
        2. To evaluate the effectiveness of daily omega-3 doses (fish oil) in preventing PPD.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The protocol predicts CMD mapping and monitoring of nutritional status throughout pregnancy&#xD;
      and once in postpartum. Women are interviewed in four time points:&#xD;
&#xD;
        1. First trimester: 8th and 13th (baseline),&#xD;
&#xD;
        2. Second trimester: 22nd-24th gestational weeks,&#xD;
&#xD;
        3. Third trimester: 34th-36th gestational weeks,&#xD;
&#xD;
        4. Postpartum: 30-45 days&#xD;
&#xD;
      The following information will be gathered:&#xD;
&#xD;
        1. Common mental disorders (CMD): MINI International Neuropsychiatric Interview, symptoms&#xD;
           of depression (Edinburgh scale - EPDS), anxiety (Trait Anxiety Inventory - TAI)&#xD;
&#xD;
        2. Dietary intake (food frequency questionnaire)&#xD;
&#xD;
        3. Anthropometric measure (stature and body weight) and physical activity&#xD;
&#xD;
        4. Biochemicals: fasting glucose, lipid profile (total cholesterol, HDL-c, LDL-c), serum&#xD;
           fatty acid composition, inflammatory markers (C-reactive protein, interleukin-6),&#xD;
           hormones (adiponectin, insulin, leptin).&#xD;
&#xD;
      All women are followed throughout pregnancy constituting the observational cohort. In the&#xD;
      second trimester, those women identified as being in risk for PPD [past history of depression&#xD;
      (DSM-IV) or presenting a score of depression (Edinburgh scale) &gt;= 9 at the baseline&#xD;
      interview] are invited to participate in the clinical trial. These women will be randomly&#xD;
      allocated in two groups:&#xD;
&#xD;
      Intervention 1: Fish oil: [1,8 g/dia n-3 (1,08 g EPA e 0,72 g DHA)+ vit E (0,2 mg/g)&#xD;
      Intervention 2: Placebo comparator: soybean oil + 1% fish oil + vit E (0,2 mg/g)&#xD;
&#xD;
      The supplementation occurs from the 22nd-24th week of pregnancy for 16 weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2009</start_date>
  <completion_date type="Actual">July 2012</completion_date>
  <primary_completion_date type="Actual">November 2011</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Major depressive episode</measure>
    <time_frame>30-45 days postpartum</time_frame>
    <description>Number of women with diagnostic of major depression in the postpartum visit (30-45 days after childbirth) using Edinburgh scale and the MINI psychiatry interview.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Gestational weight gain</measure>
    <time_frame>34-36 weeks of gestation</time_frame>
    <description>Difference between last body weight measurement in pregnancy and the first assessment(8-13 weeks of gestation).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Birth weight</measure>
    <time_frame>Postpartum</time_frame>
    <description>Neonatal birth weight (grams)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Serum fatty acids composition</measure>
    <time_frame>30-45 days of postpartum</time_frame>
    <description>Change in n-3 (DHA, EPA) fatty acid composition (mg/dl or % of total fatty acids) throughout pregnancy and 30-45 postpartum.</description>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">299</enrollment>
  <condition>Pregnancy</condition>
  <arm_group>
    <arm_group_label>Observational</arm_group_label>
    <description>Pregnant women</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Fatty acids C-reactive protein Interleukin-6&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Pregnant women attending a health care center in the city of Rio de Janeiro, Brazil&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  aged 20 to 40&#xD;
&#xD;
          -  up to 13 weeks of pregnancy&#xD;
&#xD;
          -  free from chronic or infectious diseases (except obesity)&#xD;
&#xD;
          -  residing in the study catchment area&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - twin pregnancies&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gilberto Kac, Phd</last_name>
    <role>Study Chair</role>
    <affiliation>Universidade Federal do Rio de Janeiro</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centro Municipal de Saúde Heitor Beltrão</name>
      <address>
        <city>Rio de Janeiro</city>
        <zip>20521-160</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>January 2014</verification_date>
  <study_first_submitted>May 24, 2012</study_first_submitted>
  <study_first_submitted_qc>August 3, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 8, 2012</study_first_posted>
  <last_update_submitted>January 16, 2014</last_update_submitted>
  <last_update_submitted_qc>January 16, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 17, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidade Federal do Rio de Janeiro</investigator_affiliation>
    <investigator_full_name>Gilberto Kac</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Nutritional status</keyword>
  <keyword>Mental Health</keyword>
  <keyword>Omega-3</keyword>
  <keyword>Pregnancy</keyword>
  <keyword>Postpartum depression</keyword>
  <!-- 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/NCT01660165
org study id: CAAE 0139.0.314.000-09
nct id: NCT01660165
lead sponsor: 
has dmc: No
There is increasing evidence that psychosocial factors may affect health by means of
      biological effects and changes in behavioral health. Observational studies suggest an
      association between low levels of one long chain n-3 fatty acids, DHA (docosahexaenoic acid),
      after pregnancy and the occurrence of postpartum depression (PPD). This is an observational
      cohort with 4 waves of follow-up and a nested clinical trial with pregnant women residing in
      the city of Rio de Janeiro. The general objective is to describe the magnitude and identify
      factors associated to common mental disorders (CMD) during pregnancy and postpartum giving
      emphasis to maternal nutritional status.

      Main specific objectives:

        1. To evaluate the effect of CMD in the pattern of occurrence of selected maternal and
           child outcomes (inadequacy of gestational weight gain, postpartum weight retention, low
           birthweight, small for gestational weight and prematurity), considering the effect of
           other determinant factors, and

        2. To evaluate the effectiveness of daily omega-3 doses (fish oil) in preventing PPD.
The protocol predicts CMD mapping and monitoring of nutritional status throughout pregnancy
      and once in postpartum. Women are interviewed in four time points:

        1. First trimester: 8th and 13th (baseline),

        2. Second trimester: 22nd-24th gestational weeks,

        3. Third trimester: 34th-36th gestational weeks,

        4. Postpartum: 30-45 days

      The following information will be gathered:

        1. Common mental disorders (CMD): MINI International Neuropsychiatric Interview, symptoms
           of depression (Edinburgh scale - EPDS), anxiety (Trait Anxiety Inventory - TAI)

        2. Dietary intake (food frequency questionnaire)

        3. Anthropometric measure (stature and body weight) and physical activity

        4. Biochemicals: fasting glucose, lipid profile (total cholesterol, HDL-c, LDL-c), serum
           fatty acid composition, inflammatory markers (C-reactive protein, interleukin-6),
           hormones (adiponectin, insulin, leptin).

      All women are followed throughout pregnancy constituting the observational cohort. In the
      second trimester, those women identified as being in risk for PPD [past history of depression
      (DSM-IV) or presenting a score of depression (Edinburgh scale) >= 9 at the baseline
      interview] are invited to participate in the clinical trial. These women will be randomly
      allocated in two groups:

      Intervention 1: Fish oil: [1,8 g/dia n-3 (1,08 g EPA e 0,72 g DHA)+ vit E (0,2 mg/g)
      Intervention 2: Placebo comparator: soybean oil + 1% fish oil + vit E (0,2 mg/g)

      The supplementation occurs from the 22nd-24th week of pregnancy for 16 weeks.
observational model: Cohort
time perspective: Prospective
measure: Major depressive episode
time frame: 30-45 days postpartum
description: Number of women with diagnostic of major depression in the postpartum visit (30-45 days after childbirth) using Edinburgh scale and the MINI psychiatry interview.
measure: Gestational weight gain
time frame: 34-36 weeks of gestation
description: Difference between last body weight measurement in pregnancy and the first assessment(8-13 weeks of gestation).
measure: Birth weight
time frame: Postpartum
description: Neonatal birth weight (grams)
measure: Serum fatty acids composition
time frame: 30-45 days of postpartum
description: Change in n-3 (DHA, EPA) fatty acid composition (mg/dl or % of total fatty acids) throughout pregnancy and 30-45 postpartum.
arm group label: Observational
description: Pregnant women
Fatty acids C-reactive protein Interleukin-6
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 40 Years
healthy volunteers: No
last name: Gilberto Kac, Phd
role: Study Chair
affiliation: Universidade Federal do Rio de Janeiro
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Universidade Federal do Rio de Janeiro
investigator full name: Gilberto Kac
investigator title: Professor