<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/NCT02190565</url>
  </required_header>
  <id_info>
    <org_study_id>2014/815-31/4</org_study_id>
    <nct_id>NCT02190565</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy Study of a Food Supplement for Pregnant and Lactating Women</brief_title>
  <official_title>Supplementation With WellnessPack Mama During Pregnancy and Lactation - a Randomized Double-blind, Placebo-controlled Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Oriflame Cosmetics AB</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Karolinska Institutet</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Oriflame Cosmetics AB</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>
      The purpose of this study is to determine whether a food supplement consisting of vitamins,&#xD;
      minerals and fish oil taken during and after pregnancy can decrease the need for additional&#xD;
      iron supplementation due to anemia during pregnancy, and optimize levels of nutritional&#xD;
      markers such as vitamin D and docosahexaenoic acid (DHA, an omega 3 fatty acid) in maternal&#xD;
      blood and breast milk, compared to placebo.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      200 healthy, pregnant women will be randomized to receive either active or placebo at their&#xD;
      first visit to the pre-natal centres. They will be monitored at regular intervals, blood&#xD;
      samples will be taken and they will be asked about compliance and any adverse reactions.&#xD;
&#xD;
      Approx 8 weeks after delivery, the women will come to the pre-natal centres for a check-up.&#xD;
      During this visit, a blood sample will be drawn and a breast milk sample will be collected.&#xD;
&#xD;
      The blood samples will be analysed for haemoglobin, serum ferritin, vitamin D and DHA. The&#xD;
      breast milk samples will be analysed for vitamin D and DHA.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Business decision - strategy changes and budget limitations&#xD;
  </why_stopped>
  <start_date type="Actual">April 7, 2018</start_date>
  <completion_date type="Actual">April 7, 2018</completion_date>
  <primary_completion_date type="Actual">April 7, 2018</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>Prevention</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Prevalence of anaemia in active and placebo groups</measure>
    <time_frame>pregnancy week 28-30</time_frame>
    <description>Blood will be analysed for haemoglobin and ferritin values. We will compare how many women in each group (active vs placebo) are ordinated iron supplementation due to anaemia by mid-pregnancy.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Levels of nutritional biomarkers in maternal blood and breast milk</measure>
    <time_frame>6-10 weeks after delivery</time_frame>
    <description>Levels of nutritional biomarkers such as DHA and vitamin D in maternal blood and breast milk will be measured in active and placebo groups.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Anaemia</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo consisting of two sham multivitamin and mineral tablets and two capsules of oil</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Food supplement</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Food supplement consisting of fish oil (omega 3 fatty acids DHA and EPA) and multivitamin and mineral tablets with extra iron and folic acid</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Food supplement</intervention_name>
    <description>Randomized double-blind, placebo-controlled</description>
    <arm_group_label>Food supplement</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>WellnessPack mama</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy pregnant women aged 18-40 years with a body mass index (BMI) above 18.5 and&#xD;
             below 35 kg/m2 who visit pre-natal clinics (midwife centres) to register.&#xD;
&#xD;
          -  Nulliparous and multiparous women.&#xD;
&#xD;
          -  The women must be able to understand verbal and written information in Swedish to give&#xD;
             an informed consent to participate in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women below the age of 18 or above 40 years old.&#xD;
&#xD;
          -  Women with a BMI below 18.5 or above 35 kg/m2.&#xD;
&#xD;
          -  Women with any form of anaemia as diagnosed at the first visit to the prenatal clinic.&#xD;
&#xD;
          -  Women expecting two or more babies.&#xD;
&#xD;
          -  Women who have undergone bariatric surgery.&#xD;
&#xD;
          -  Women on medication with pharmaceuticals that could affect the result of the study,&#xD;
             e.g., vitamin K antagonists.&#xD;
&#xD;
          -  Women who are allergic to any of the components of WellnessPack mama, e.g., fish.&#xD;
&#xD;
          -  Women who suffer from drug or alcohol abuse.&#xD;
&#xD;
          -  Women who suffer from known severe eating disorders.&#xD;
&#xD;
          -  Women who suffer from chronic diseases that could affect gastrointestinal absorption&#xD;
             and metabolism.&#xD;
&#xD;
          -  Women who want to continue or start using similar food supplements in addition to&#xD;
             WellnessPack mama/placebo, unless recommended by a physician or midwife, will be&#xD;
             excluded from the study.&#xD;
&#xD;
          -  Upon miscarriage or transfer to prenatal care specialist, the subject is excluded from&#xD;
             the study.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Angelica Lindén Hirschberg, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Karolinska Institutet, Stockholm, Sweden</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Woman and Child Health, Division of Obstetrics and Gynecology, Karolinska Institutet</name>
      <address>
        <city>Stockholm</city>
        <zip>SE-171 76</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <link>
    <url>http://whqlibdoc.who.int/publications/2008/9789241596657_eng.pdf</url>
    <description>World Health Organization. Worldwide prevalence of anaemia 1993-2005: WHO Global Database on Anaemia.</description>
  </link>
  <reference>
    <citation>Bhutta ZA, Das JK, Rizvi A, Gaffey MF, Walker N, Horton S, Webb P, Lartey A, Black RE; Lancet Nutrition Interventions Review Group, the Maternal and Child Nutrition Study Group. Evidence-based interventions for improvement of maternal and child nutrition: what can be done and at what cost? Lancet. 2013 Aug 3;382(9890):452-477. doi: 10.1016/S0140-6736(13)60996-4. Epub 2013 Jun 6. Erratum In: Lancet. 2013 Aug 3;382(9890):396.</citation>
    <PMID>23746776</PMID>
  </reference>
  <reference>
    <citation>Kawai K, Spiegelman D, Shankar AH, Fawzi WW. Maternal multiple micronutrient supplementation and pregnancy outcomes in developing countries: meta-analysis and meta-regression. Bull World Health Organ. 2011 Jun 1;89(6):402-411B. doi: 10.2471/BLT.10.083758. Epub 2011 Mar 21.</citation>
    <PMID>21673856</PMID>
  </reference>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>July 9, 2014</study_first_submitted>
  <study_first_submitted_qc>July 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 15, 2014</study_first_posted>
  <last_update_submitted>December 3, 2018</last_update_submitted>
  <last_update_submitted_qc>December 3, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 5, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>pregnancy, lactation, food supplement, anaemia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anemia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT02190565
org study id: 2014/815-31/4
nct id: NCT02190565
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to determine whether a food supplement consisting of vitamins,
      minerals and fish oil taken during and after pregnancy can decrease the need for additional
      iron supplementation due to anemia during pregnancy, and optimize levels of nutritional
      markers such as vitamin D and docosahexaenoic acid (DHA, an omega 3 fatty acid) in maternal
      blood and breast milk, compared to placebo.
200 healthy, pregnant women will be randomized to receive either active or placebo at their
      first visit to the pre-natal centres. They will be monitored at regular intervals, blood
      samples will be taken and they will be asked about compliance and any adverse reactions.

      Approx 8 weeks after delivery, the women will come to the pre-natal centres for a check-up.
      During this visit, a blood sample will be drawn and a breast milk sample will be collected.

      The blood samples will be analysed for haemoglobin, serum ferritin, vitamin D and DHA. The
      breast milk samples will be analysed for vitamin D and DHA.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Care Provider, Investigator)
measure: Prevalence of anaemia in active and placebo groups
time frame: pregnancy week 28-30
description: Blood will be analysed for haemoglobin and ferritin values. We will compare how many women in each group (active vs placebo) are ordinated iron supplementation due to anaemia by mid-pregnancy.
measure: Levels of nutritional biomarkers in maternal blood and breast milk
time frame: 6-10 weeks after delivery
description: Levels of nutritional biomarkers such as DHA and vitamin D in maternal blood and breast milk will be measured in active and placebo groups.
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo consisting of two sham multivitamin and mineral tablets and two capsules of oil
arm group label: Food supplement
arm group type: Active Comparator
description: Food supplement consisting of fish oil (omega 3 fatty acids DHA and EPA) and multivitamin and mineral tablets with extra iron and folic acid
intervention type: Dietary Supplement
intervention name: Food supplement
description: Randomized double-blind, placebo-controlled
arm group label: Food supplement
arm group label: Placebo
other name: WellnessPack mama
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Angelica Lindén Hirschberg, Professor
role: Principal Investigator
affiliation: Karolinska Institutet, Stockholm, Sweden
facility: 
country: Sweden
url: http://whqlibdoc.who.int/publications/2008/9789241596657_eng.pdf
description: World Health Organization. Worldwide prevalence of anaemia 1993-2005: WHO Global Database on Anaemia.
citation: Bhutta ZA, Das JK, Rizvi A, Gaffey MF, Walker N, Horton S, Webb P, Lartey A, Black RE; Lancet Nutrition Interventions Review Group, the Maternal and Child Nutrition Study Group. Evidence-based interventions for improvement of maternal and child nutrition: what can be done and at what cost? Lancet. 2013 Aug 3;382(9890):452-477. doi: 10.1016/S0140-6736(13)60996-4. Epub 2013 Jun 6. Erratum In: Lancet. 2013 Aug 3;382(9890):396.
PMID: 23746776
citation: Kawai K, Spiegelman D, Shankar AH, Fawzi WW. Maternal multiple micronutrient supplementation and pregnancy outcomes in developing countries: meta-analysis and meta-regression. Bull World Health Organ. 2011 Jun 1;89(6):402-411B. doi: 10.2471/BLT.10.083758. Epub 2011 Mar 21.
PMID: 21673856
responsible party type: Sponsor
mesh term: Anemia
sharing ipd: No