<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/NCT01712165</url>
  </required_header>
  <id_info>
    <org_study_id>FON-ALTHEA-SG-2012-01</org_study_id>
    <nct_id>NCT01712165</nct_id>
  </id_info>
  <brief_title>Micronutrient-supplemented Milk Study in Women of Childbearing Age</brief_title>
  <official_title>Micronutrient-supplemented Milk Study in Women of Childbearing Age</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fonterra Research Centre</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Changi General Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Fonterra Research Centre</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine if consuming ANMUM Materna (a fortified milk&#xD;
      product) over a 12-week period increases red blood cell folate concentrations in women of&#xD;
      childbearing age in Singapore, compared to an equivalent amount of standard (unfortified)&#xD;
      milk.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Folic acid (~400 µg/day) taken around the time of conception significantly reduces the risk&#xD;
      of a neural tube defect (NTD)-affected pregnancy. Strategies to reduce NTD with folic acid,&#xD;
      include supplement use and food fortification. An attractive strategy for NTD prevention is&#xD;
      the use of fortified foods targeted for use by women planning a pregnancy. Fonterra currently&#xD;
      markets a fortified-milk (ANMUM Materna) in Asia, designed for use prior to and during&#xD;
      pregnancy. This milk product, if consumed as directed, provides ~400 µg folic acid per day.&#xD;
      It is not known whether ANMUM Materna will reduce NTD rate. However, in a case-control study&#xD;
      the risk of NTD was inversely associated with maternal red blood cell (RBC) folate&#xD;
      concentrations. Accordingly, if ANMUM Materna increases RBC folate, it could be expected to&#xD;
      decrease NTD risk.&#xD;
&#xD;
      In this study, the ANMUM Materna fortified milk will be tested against a standard control&#xD;
      (unfortified) milk over a 12 week period. The subjects will consume 75g of milk powder daily&#xD;
      throughout the supplementation period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2013</start_date>
  <completion_date type="Actual">October 2013</completion_date>
  <primary_completion_date type="Actual">October 2013</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>Health Services Research</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Increase in red blood cell folate concentration</measure>
    <time_frame>12 weeks</time_frame>
    <description>To determine if consuming ANMUM Materna over a 12-week period increases red blood cell folate concentrations in women of childbearing age in Singapore, compared to an equivalent amount of standard (unfortified) milk.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Reduction in homocysteine concentration</measure>
    <time_frame>12 weeks</time_frame>
    <description>To determine if consuming ANMUM Materna over a 12-week period lowers homocysteine concentrations in women of childbearing age, compared to an equivalent amount of standard (unfortified) milk.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Increase in plasma folate concentration</measure>
    <time_frame>12 weeks</time_frame>
    <description>To determine if consuming ANMUM Materna over a 12-week period increases plasma folate concentrations in women of childbearing age, compared to an equivalent amount of standard (unfortified) milk.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Increase in plasma vitamin B12 concentration</measure>
    <time_frame>12 weeks</time_frame>
    <description>To determine if consuming ANMUM over a 12-week period increases plasma vitamin B12 concentrations in women of childbearing age, compared to an equivalent amount of standard (unfortified) milk.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">70</enrollment>
  <condition>Increase the Concentration of Folic Acid in Women of Childbearing Age</condition>
  <arm_group>
    <arm_group_label>ANMUM Materna</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>75g milk powder in 400 ml water daily for 12 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>75g of milk powder in 400 ml water for 12 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>ANMUM Materna</intervention_name>
    <arm_group_label>ANMUM Materna</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Control (milk powder)</intervention_name>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female 21-35 years old.&#xD;
&#xD;
          -  Able to understand the nature and purpose of the study, including potential risks and&#xD;
             side effects.&#xD;
&#xD;
          -  Willing to consent to study participation and to comply with study requirements.&#xD;
&#xD;
          -  Negative Pregnancy test at screening&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Consumption of vitamins and/or mineral supplements known to contain folate 6 months&#xD;
             prior.&#xD;
&#xD;
          -  Chronic disease.&#xD;
&#xD;
          -  Milk and/or lactose-intolerant.&#xD;
&#xD;
          -  Pregnancy in the last 12 months, or currently planning a pregnancy.&#xD;
&#xD;
          -  Prior history of NTD-affected pregnancy&#xD;
&#xD;
          -  Serum Folate deficiency&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Magdalin Cheong</last_name>
    <role>Principal Investigator</role>
    <affiliation>Changi General Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Changi General Hospital</name>
      <address>
        <city>Singapore</city>
        <zip>529889</zip>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Singapore</country>
  </location_countries>
  <verification_date>October 2013</verification_date>
  <study_first_submitted>October 19, 2012</study_first_submitted>
  <study_first_submitted_qc>October 22, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 23, 2012</study_first_posted>
  <last_update_submitted>October 10, 2013</last_update_submitted>
  <last_update_submitted_qc>October 10, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 11, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Folic acid supplement</keyword>
  <keyword>Neural tube defect-affected pregnancy</keyword>
  <keyword>Homocysteine concentration</keyword>
  <keyword>Plasma Folate concentration</keyword>
  <keyword>Plasma vitamin B12 concentration</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/NCT01712165
org study id: FON-ALTHEA-SG-2012-01
nct id: NCT01712165
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to determine if consuming ANMUM Materna (a fortified milk
      product) over a 12-week period increases red blood cell folate concentrations in women of
      childbearing age in Singapore, compared to an equivalent amount of standard (unfortified)
      milk.
Folic acid (~400 µg/day) taken around the time of conception significantly reduces the risk
      of a neural tube defect (NTD)-affected pregnancy. Strategies to reduce NTD with folic acid,
      include supplement use and food fortification. An attractive strategy for NTD prevention is
      the use of fortified foods targeted for use by women planning a pregnancy. Fonterra currently
      markets a fortified-milk (ANMUM Materna) in Asia, designed for use prior to and during
      pregnancy. This milk product, if consumed as directed, provides ~400 µg folic acid per day.
      It is not known whether ANMUM Materna will reduce NTD rate. However, in a case-control study
      the risk of NTD was inversely associated with maternal red blood cell (RBC) folate
      concentrations. Accordingly, if ANMUM Materna increases RBC folate, it could be expected to
      decrease NTD risk.

      In this study, the ANMUM Materna fortified milk will be tested against a standard control
      (unfortified) milk over a 12 week period. The subjects will consume 75g of milk powder daily
      throughout the supplementation period.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Double (Participant, Investigator)
measure: Increase in red blood cell folate concentration
time frame: 12 weeks
description: To determine if consuming ANMUM Materna over a 12-week period increases red blood cell folate concentrations in women of childbearing age in Singapore, compared to an equivalent amount of standard (unfortified) milk.
measure: Reduction in homocysteine concentration
time frame: 12 weeks
description: To determine if consuming ANMUM Materna over a 12-week period lowers homocysteine concentrations in women of childbearing age, compared to an equivalent amount of standard (unfortified) milk.
measure: Increase in plasma folate concentration
time frame: 12 weeks
description: To determine if consuming ANMUM Materna over a 12-week period increases plasma folate concentrations in women of childbearing age, compared to an equivalent amount of standard (unfortified) milk.
measure: Increase in plasma vitamin B12 concentration
time frame: 12 weeks
description: To determine if consuming ANMUM over a 12-week period increases plasma vitamin B12 concentrations in women of childbearing age, compared to an equivalent amount of standard (unfortified) milk.
arm group label: ANMUM Materna
arm group type: Active Comparator
description: 75g milk powder in 400 ml water daily for 12 weeks.
arm group label: Control
arm group type: Placebo Comparator
description: 75g of milk powder in 400 ml water for 12 weeks.
intervention type: Dietary Supplement
intervention name: ANMUM Materna
arm group label: ANMUM Materna
intervention type: Dietary Supplement
intervention name: Control (milk powder)
arm group label: Control
criteria: 
gender: Female
minimum age: 21 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Magdalin Cheong
role: Principal Investigator
affiliation: Changi General Hospital
facility: 
country: Singapore
responsible party type: Sponsor