<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/NCT02229526</url>
  </required_header>
  <id_info>
    <org_study_id>DT2006-41-6257</org_study_id>
    <nct_id>NCT02229526</nct_id>
  </id_info>
  <brief_title>Fish Oil Trials in Pregnancy for the Prevention of Pregnancy Complications ('FOTIP')</brief_title>
  <acronym>FOTIP</acronym>
  <official_title>Randomised Clinical Trials of Fish Oil Supplementation in High Risk Pregnancies</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sjurdur Frodi Olsen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Rigshospitalet, Denmark</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Centre for Fetal Programming, Denmark</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The initial trial examined if fish oil supplementation during pregnancy could reduce the risk&#xD;
      of pregnancy induced hypertension, intrauterine growth retardation, and preterm birth in&#xD;
      pregnancies that were at increased risk of these complications. The study was designed as a&#xD;
      multi-centre clinical trial based in 19 hospitals in seven countries in Europe.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 1990</start_date>
  <completion_date type="Actual">December 1999</completion_date>
  <primary_completion_date type="Actual">January 1996</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>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pregnancy Induced Hypertension</measure>
    <time_frame>Participants will be followed for the duration of pregnancy and the first few days after delivery, on average 20-26 weeks from recruitment and randomization.</time_frame>
    <description>One or more recorded measurements of a diastolic blood pressure of above 90 mmHg at rest</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Intrauterine growth retardation</measure>
    <time_frame>Participants will be followed for the duration of pregnancy and the first few days after delivery, on average 20-26 weeks from recruitment and randomization.</time_frame>
    <description>Birth weight below the 10th centile, as assessed from the infant's birth weight, gestational age and gender, on the basis of Danish standards (Br J Obstet Gynaecol 1986; 93: 128-134; and Acta Obstet Gynecol Scand 1985; 64: 65-70).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Preterm delivery</measure>
    <time_frame>Participants will be followed for the duration of pregnancy and the first few days after delivery, on average 20-26 weeks from recruitment and randomization.</time_frame>
    <description>Delivery at an estimated gestational age of less than 259 days (37 completed weeks)</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">1619</enrollment>
  <condition>Preterm Birth</condition>
  <condition>Intrauterine Growth Retardation</condition>
  <condition>Pregnancy Induced Hypertension</condition>
  <arm_group>
    <arm_group_label>Low dose fish oil</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Low dose olive oil</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>High dose fish oil</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>High dose olive oil</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Low dose fish oil</intervention_name>
    <description>Four 1g gelatine capsules with fish oil (Pikasol: 32 % eicosapentaenoic acid (20:5n-3), 23 % docosahexaenoic acid (22:6n-3) and 2 mg tocopherol/ml)) corresponding to 2.7 g n-3 fatty acids per day.</description>
    <arm_group_label>Low dose fish oil</arm_group_label>
    <other_name>Pikasol</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Low dose olive oil</intervention_name>
    <description>Four 1 g capsules with olive oil (72 % oleic acid (18:1n-9) and 12 % linoleic acid (18:2n-6)) per day.</description>
    <arm_group_label>Low dose olive oil</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>High dose fish oil</intervention_name>
    <description>Nine 1g gelatine capsules with fish oil (Pikasol: 32 % eicosapentaenoic acid (20:5n-3), 23 % docosahexaenoic acid (22:6n-3) and 2 mg tocopherol/ml)) corresponding to 6.1 g n-3 fatty acids per day.</description>
    <arm_group_label>High dose fish oil</arm_group_label>
    <other_name>Pikasol</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>High dose olive oil</intervention_name>
    <description>Nine 1g gelatine capsules with olive oil (72 % oleic acid (18:1n-9) and 12 % linoleic acid (18:2n-6)) per day.</description>
    <arm_group_label>High dose olive oil</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  There were six subgroups with different inclusion criteria:&#xD;
&#xD;
          -  The low dose (prophylactic) section enrolled women who after 16 weeks of gestation had&#xD;
             been identified with an uncomplicated pregnancy, who in an earlier pregnancy had&#xD;
             experienced preterm delivery (this was subgroup 1)&#xD;
&#xD;
          -  Intrauterine growth retardation (subgroup 2) or pregnancy induced hypertension&#xD;
             (subgroup 3)&#xD;
&#xD;
          -  Women who had been identified with twin pregnancies (subgroup 4)&#xD;
&#xD;
          -  The high dose ('therapeutic') section enrolled women with threatening pre-eclampsia&#xD;
             (subgroup 5) or suspected intrauterine growth retardation in the current pregnancy&#xD;
             (subgroup 6).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diabetes mellitus in or before pregnancy&#xD;
&#xD;
          -  Diagnosed severe fetal malformation or hydrops in current pregnancy&#xD;
&#xD;
          -  Suspicion in current pregnancy, or occurrence in an earlier pregnancy, of placental&#xD;
             abruption&#xD;
&#xD;
          -  Drug or alcohol abuse&#xD;
&#xD;
          -  Regular intake of fish oil or of non-steroidal antiinflammatory agents or other drugs&#xD;
             with an effect on thombocyte function or eicosanoid metabolism&#xD;
&#xD;
          -  Allergy to fish products.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Niels J Secher, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rigshospitalet, Denmark</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sjurdur F Olsen, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Center for Fetal Programming, Denmark</affiliation>
  </overall_official>
  <results_reference>
    <citation>Olsen SF, Secher NJ, Tabor A, Weber T, Walker JJ, Gluud C. Randomised clinical trials of fish oil supplementation in high risk pregnancies. Fish Oil Trials In Pregnancy (FOTIP) Team. BJOG. 2000 Mar;107(3):382-95. doi: 10.1111/j.1471-0528.2000.tb13235.x.</citation>
    <PMID>10740336</PMID>
  </results_reference>
  <results_reference>
    <citation>Olsen SF, Osterdal ML, Salvig JD, Weber T, Tabor A, Secher NJ. Duration of pregnancy in relation to fish oil supplementation and habitual fish intake: a randomised clinical trial with fish oil. Eur J Clin Nutr. 2007 Aug;61(8):976-85. doi: 10.1038/sj.ejcn.1602609. Epub 2007 Feb 7.</citation>
    <PMID>17299499</PMID>
  </results_reference>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>March 3, 2014</study_first_submitted>
  <study_first_submitted_qc>August 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 1, 2014</study_first_posted>
  <last_update_submitted>August 29, 2014</last_update_submitted>
  <last_update_submitted_qc>August 29, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 1, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Centre for Fetal Programming, Denmark</investigator_affiliation>
    <investigator_full_name>Sjurdur Frodi Olsen</investigator_full_name>
    <investigator_title>Chief Physician, Centre-Leader</investigator_title>
  </responsible_party>
  <keyword>Fish oil supplementation</keyword>
  <keyword>RCT</keyword>
  <keyword>High risk pregnancies</keyword>
  <keyword>Twin pregnancy</keyword>
  <keyword>Preterm birth</keyword>
  <keyword>Intrauterine growth retardation</keyword>
  <keyword>Pregnancy induced hypertension</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Premature Birth</mesh_term>
    <mesh_term>Hypertension, Pregnancy-Induced</mesh_term>
    <mesh_term>Fetal Growth Retardation</mesh_term>
    <mesh_term>Hypertension</mesh_term>
  </condition_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/NCT02229526
org study id: DT2006-41-6257
nct id: NCT02229526
lead sponsor: 
collaborator: 
has dmc: Yes
The initial trial examined if fish oil supplementation during pregnancy could reduce the risk
      of pregnancy induced hypertension, intrauterine growth retardation, and preterm birth in
      pregnancies that were at increased risk of these complications. The study was designed as a
      multi-centre clinical trial based in 19 hospitals in seven countries in Europe.
allocation: Randomized
intervention model: Parallel Assignment
masking: Triple (Participant, Care Provider, Investigator)
measure: Pregnancy Induced Hypertension
time frame: Participants will be followed for the duration of pregnancy and the first few days after delivery, on average 20-26 weeks from recruitment and randomization.
description: One or more recorded measurements of a diastolic blood pressure of above 90 mmHg at rest
measure: Intrauterine growth retardation
time frame: Participants will be followed for the duration of pregnancy and the first few days after delivery, on average 20-26 weeks from recruitment and randomization.
description: Birth weight below the 10th centile, as assessed from the infant's birth weight, gestational age and gender, on the basis of Danish standards (Br J Obstet Gynaecol 1986; 93: 128-134; and Acta Obstet Gynecol Scand 1985; 64: 65-70).
measure: Preterm delivery
time frame: Participants will be followed for the duration of pregnancy and the first few days after delivery, on average 20-26 weeks from recruitment and randomization.
description: Delivery at an estimated gestational age of less than 259 days (37 completed weeks)
arm group label: Low dose fish oil
arm group type: Active Comparator
arm group label: Low dose olive oil
arm group type: Placebo Comparator
arm group label: High dose fish oil
arm group type: Experimental
arm group label: High dose olive oil
arm group type: Placebo Comparator
intervention type: Dietary Supplement
intervention name: Low dose fish oil
description: Four 1g gelatine capsules with fish oil (Pikasol: 32 % eicosapentaenoic acid (20:5n-3), 23 % docosahexaenoic acid (22:6n-3) and 2 mg tocopherol/ml)) corresponding to 2.7 g n-3 fatty acids per day.
arm group label: Low dose fish oil
other name: Pikasol
intervention type: Dietary Supplement
intervention name: Low dose olive oil
description: Four 1 g capsules with olive oil (72 % oleic acid (18:1n-9) and 12 % linoleic acid (18:2n-6)) per day.
arm group label: Low dose olive oil
intervention type: Dietary Supplement
intervention name: High dose fish oil
description: Nine 1g gelatine capsules with fish oil (Pikasol: 32 % eicosapentaenoic acid (20:5n-3), 23 % docosahexaenoic acid (22:6n-3) and 2 mg tocopherol/ml)) corresponding to 6.1 g n-3 fatty acids per day.
arm group label: High dose fish oil
other name: Pikasol
intervention type: Dietary Supplement
intervention name: High dose olive oil
description: Nine 1g gelatine capsules with olive oil (72 % oleic acid (18:1n-9) and 12 % linoleic acid (18:2n-6)) per day.
arm group label: High dose olive oil
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
last name: Niels J Secher, Professor
role: Principal Investigator
affiliation: Rigshospitalet, Denmark
last name: Sjurdur F Olsen, Professor
role: Principal Investigator
affiliation: Center for Fetal Programming, Denmark
citation: Olsen SF, Secher NJ, Tabor A, Weber T, Walker JJ, Gluud C. Randomised clinical trials of fish oil supplementation in high risk pregnancies. Fish Oil Trials In Pregnancy (FOTIP) Team. BJOG. 2000 Mar;107(3):382-95. doi: 10.1111/j.1471-0528.2000.tb13235.x.
PMID: 10740336
citation: Olsen SF, Osterdal ML, Salvig JD, Weber T, Tabor A, Secher NJ. Duration of pregnancy in relation to fish oil supplementation and habitual fish intake: a randomised clinical trial with fish oil. Eur J Clin Nutr. 2007 Aug;61(8):976-85. doi: 10.1038/sj.ejcn.1602609. Epub 2007 Feb 7.
PMID: 17299499
responsible party type: Sponsor-Investigator
investigator affiliation: Centre for Fetal Programming, Denmark
investigator full name: Sjurdur Frodi Olsen
investigator title: Chief Physician, Centre-Leader
mesh term: Premature Birth
mesh term: Hypertension, Pregnancy-Induced
mesh term: Fetal Growth Retardation
mesh term: Hypertension