<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/NCT02221752</url>
  </required_header>
  <id_info>
    <org_study_id>Vifor/PFH supplement trial</org_study_id>
    <nct_id>NCT02221752</nct_id>
  </id_info>
  <brief_title>Impact of Iron/Folic Acid vs Folic Acid Supplements During Pregnancy on Maternal and Child Health</brief_title>
  <official_title>Impact of Iron/Folic Acid Versus Folic Acid Supplements During Pregnancy on Maternal and Children's Health: A Randomized Controlled Trial in China</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zhao gengli</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Vifor Pharma</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Peking University First Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      According to a national study in 2002, the prevalence of ID, IDA, and ID+IDA among pregnant&#xD;
      women in China was 42.6%, 9.1%, and 61.7% respectively. A similar study in Hebei province at&#xD;
      the same time showed that the prevalence of IDA among pregnant and lactating mothers was&#xD;
      46.39% and 47.21% respectively. There was a significant difference between urban and rural&#xD;
      areas. Women living in rural areas had higher chances of having IDA (p&lt;0.01). WHO and UNICEF&#xD;
      recommend taking iron, folic acid and multiple micronutrients during pregnancy. However, we&#xD;
      don't know much about their influence on maternal and infant health and their clinical&#xD;
      effectiveness. Health Department of China recommends taking 400ug folic acid before pregnancy&#xD;
      and during early pregnancy. But for various reasons, not all expecting mothers take this&#xD;
      advice. Besides, we don't have a national level technical standard of how to take nutrition&#xD;
      supplements during pregnancy. Therefore, it's crucial for us to study if iron/folic acid or&#xD;
      folic acid only can prevent perinatal complications, as well as their influences on infant&#xD;
      and toddler health.&#xD;
&#xD;
      The purpose of this study is to test whether taking iron/folic acid and folic acid only from&#xD;
      early pregnancy until delivery will lower the chances of pregnancy complications, and to see&#xD;
      how supplements affect gestation results. As well, it will evaluate a) whether taking iron&#xD;
      supplement during pregnancy can prevent IDA during pregnancy; b) whether taking iron&#xD;
      supplement can increase mother and fetus iron storage; and c) how mother's iron level affects&#xD;
      newborn's iron level. We hope to understand nutrition conditions during pregnancy and&#xD;
      investigate the relations between pregnancy diet and complications during pregnancy, weight&#xD;
      gain during pregnancy, and newborn birth weight. We will evaluate the influence of taking&#xD;
      iron and folic acid during pregnancy on the health of infants and toddlers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Iron deficiency (ID) is the world's most common single nutrient disorder, differentially&#xD;
      affecting pregnant women and infants everywhere. The study was conducted in China, a rapidly&#xD;
      developing country where ID often occurs among pregnant women and infants in the absence of&#xD;
      generalized undernutrition. The study was a collaboration between Peking University First&#xD;
      Hospital and three local hospitals (Sanhe Maternity and Child Health Care Center [MCHC],&#xD;
      Sanhe General County Hospital, and Sanhe Hospital of Traditional Chinese Medicine). Eligible&#xD;
      pregnant women were enrolled from June 2009 through December 2011 and randomized in a 1:1&#xD;
      ratio to receive iron and folic acid or folic acid only. The study protocol was approved by&#xD;
      the institutional review board of Peking University First Hospital, Beijing, China. Women&#xD;
      were recruited (n=2367) at their first prenatal visit at Sanhe MCHC. Those with uncomplicated&#xD;
      singleton pregnancies and first prenatal visits ≤ 20 weeks gestation were invited to&#xD;
      participate. Women were randomized and received 2 supplements: iron/placebo and folic acid.&#xD;
      Project personnel instructed the participants to take two capsules per day (one of each kind&#xD;
      of supplement) from enrollment to delivery. Participants received a 3-month supply of each&#xD;
      supplement upon enrollment and at the second study visit (26-30 weeks). The number of doses&#xD;
      received and consumed or missed was recorded by project personnel. The primary outcomes were&#xD;
      maternal iron status at follow-up visits (26-30 weeks and 36-40 weeks), cord-blood iron&#xD;
      status, and infant gestational age and birth weight. Data analysis compares pregnancy iron&#xD;
      level between two study groups and how it relates to pregnancy outcomes, including pregnancy&#xD;
      and delivery complications, preterm rate, perinatal death rate, and birth rate. Data analysis&#xD;
      also includes evaluating pregnancy nutrition conditions and analyzing associations with&#xD;
      weight changes during pregnancy, and rates of pregnancy diabetes, pregnancy high blood&#xD;
      pressure, fetus growth restriction, low birth weight, and fetal macrosomia. Up to 75% of&#xD;
      pregnant women worldwide are anemic, with about half due to ID. The public health&#xD;
      implications of study findings could be profound.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2009</start_date>
  <completion_date type="Actual">December 2011</completion_date>
  <primary_completion_date type="Actual">December 2011</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Maternal iron status at follow-up prenatal visit</measure>
    <time_frame>26-30 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Maternal iron status at follow-up prenatal visit</measure>
    <time_frame>36-40 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cord-blood iron status</measure>
    <time_frame>delivery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infant gestational age</measure>
    <time_frame>delivery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infant birth weight</measure>
    <time_frame>delivery</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">2367</enrollment>
  <condition>Iron Deficiency</condition>
  <condition>Iron Deficiency Anemia</condition>
  <arm_group>
    <arm_group_label>Folic acid</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Mothers randomized to receive 2 capsules per day: one with placebo and one with 0.40 mg folic acid from enrollment to delivery.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ferrous Sulfate + folic acid</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Mothers randomized to receive 2 capsules per day: one with iron (300 mg ferrous sulfate [60 mg elemental iron]) and the other with 0.40 mg folic acid from enrollment to delivery.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Ferrous Sulfate + folic acid</intervention_name>
    <description>Mothers randomized to receive 2 capsules per day: one with iron (300 mg ferrous sulfate [60 mg elemental iron]) and the other with 0.40 mg folic acid from enrollment to delivery.</description>
    <arm_group_label>Ferrous Sulfate + folic acid</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Folic acid</intervention_name>
    <description>Mothers randomized to receive 2 capsules per day: one with placebo and one with 0.40 mg folic acid from enrollment to delivery.</description>
    <arm_group_label>Folic acid</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  uncomplicated singleton pregnancy, first enrollment visit ≤ 20 weeks gestation -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  &lt; 18 years of age&#xD;
&#xD;
          -  did not live in the county&#xD;
&#xD;
          -  did not anticipate delivery at participating hospital&#xD;
&#xD;
          -  were not mentally competent&#xD;
&#xD;
          -  had a chronic health problem or hemoglobin &lt; 100 g/L at the initial visit&#xD;
&#xD;
          -  were taking iron at the time.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Zhao Gengli, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Peking University First Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Peking University First Hospital</name>
      <address>
        <city>Beijing</city>
        <zip>100034</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 18, 2014</study_first_submitted>
  <study_first_submitted_qc>August 19, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 20, 2014</study_first_posted>
  <last_update_submitted>August 19, 2014</last_update_submitted>
  <last_update_submitted_qc>August 19, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 20, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Peking University First Hospital</investigator_affiliation>
    <investigator_full_name>Zhao gengli</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>iron deficiency</keyword>
  <keyword>iron deficiency anemia</keyword>
  <keyword>infant</keyword>
  <keyword>pregnancy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anemia, Iron-Deficiency</mesh_term>
    <mesh_term>Iron Deficiencies</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Folic Acid</mesh_term>
    <mesh_term>Vitamin B Complex</mesh_term>
  </intervention_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/NCT02221752
org study id: Vifor/PFH supplement trial
nct id: NCT02221752
lead sponsor: 
collaborator: 
has dmc: Yes
According to a national study in 2002, the prevalence of ID, IDA, and ID+IDA among pregnant
      women in China was 42.6%, 9.1%, and 61.7% respectively. A similar study in Hebei province at
      the same time showed that the prevalence of IDA among pregnant and lactating mothers was
      46.39% and 47.21% respectively. There was a significant difference between urban and rural
      areas. Women living in rural areas had higher chances of having IDA (p<0.01). WHO and UNICEF
      recommend taking iron, folic acid and multiple micronutrients during pregnancy. However, we
      don't know much about their influence on maternal and infant health and their clinical
      effectiveness. Health Department of China recommends taking 400ug folic acid before pregnancy
      and during early pregnancy. But for various reasons, not all expecting mothers take this
      advice. Besides, we don't have a national level technical standard of how to take nutrition
      supplements during pregnancy. Therefore, it's crucial for us to study if iron/folic acid or
      folic acid only can prevent perinatal complications, as well as their influences on infant
      and toddler health.

      The purpose of this study is to test whether taking iron/folic acid and folic acid only from
      early pregnancy until delivery will lower the chances of pregnancy complications, and to see
      how supplements affect gestation results. As well, it will evaluate a) whether taking iron
      supplement during pregnancy can prevent IDA during pregnancy; b) whether taking iron
      supplement can increase mother and fetus iron storage; and c) how mother's iron level affects
      newborn's iron level. We hope to understand nutrition conditions during pregnancy and
      investigate the relations between pregnancy diet and complications during pregnancy, weight
      gain during pregnancy, and newborn birth weight. We will evaluate the influence of taking
      iron and folic acid during pregnancy on the health of infants and toddlers.
Iron deficiency (ID) is the world's most common single nutrient disorder, differentially
      affecting pregnant women and infants everywhere. The study was conducted in China, a rapidly
      developing country where ID often occurs among pregnant women and infants in the absence of
      generalized undernutrition. The study was a collaboration between Peking University First
      Hospital and three local hospitals (Sanhe Maternity and Child Health Care Center [MCHC],
      Sanhe General County Hospital, and Sanhe Hospital of Traditional Chinese Medicine). Eligible
      pregnant women were enrolled from June 2009 through December 2011 and randomized in a 1:1
      ratio to receive iron and folic acid or folic acid only. The study protocol was approved by
      the institutional review board of Peking University First Hospital, Beijing, China. Women
      were recruited (n=2367) at their first prenatal visit at Sanhe MCHC. Those with uncomplicated
      singleton pregnancies and first prenatal visits ≤ 20 weeks gestation were invited to
      participate. Women were randomized and received 2 supplements: iron/placebo and folic acid.
      Project personnel instructed the participants to take two capsules per day (one of each kind
      of supplement) from enrollment to delivery. Participants received a 3-month supply of each
      supplement upon enrollment and at the second study visit (26-30 weeks). The number of doses
      received and consumed or missed was recorded by project personnel. The primary outcomes were
      maternal iron status at follow-up visits (26-30 weeks and 36-40 weeks), cord-blood iron
      status, and infant gestational age and birth weight. Data analysis compares pregnancy iron
      level between two study groups and how it relates to pregnancy outcomes, including pregnancy
      and delivery complications, preterm rate, perinatal death rate, and birth rate. Data analysis
      also includes evaluating pregnancy nutrition conditions and analyzing associations with
      weight changes during pregnancy, and rates of pregnancy diabetes, pregnancy high blood
      pressure, fetus growth restriction, low birth weight, and fetal macrosomia. Up to 75% of
      pregnant women worldwide are anemic, with about half due to ID. The public health
      implications of study findings could be profound.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Maternal iron status at follow-up prenatal visit
time frame: 26-30 weeks
measure: Maternal iron status at follow-up prenatal visit
time frame: 36-40 weeks
measure: Cord-blood iron status
time frame: delivery
measure: Infant gestational age
time frame: delivery
measure: Infant birth weight
time frame: delivery
arm group label: Folic acid
arm group type: Experimental
description: Mothers randomized to receive 2 capsules per day: one with placebo and one with 0.40 mg folic acid from enrollment to delivery.
arm group label: Ferrous Sulfate + folic acid
arm group type: Experimental
description: Mothers randomized to receive 2 capsules per day: one with iron (300 mg ferrous sulfate [60 mg elemental iron]) and the other with 0.40 mg folic acid from enrollment to delivery.
intervention type: Dietary Supplement
intervention name: Ferrous Sulfate + folic acid
description: Mothers randomized to receive 2 capsules per day: one with iron (300 mg ferrous sulfate [60 mg elemental iron]) and the other with 0.40 mg folic acid from enrollment to delivery.
arm group label: Ferrous Sulfate + folic acid
intervention type: Dietary Supplement
intervention name: Folic acid
description: Mothers randomized to receive 2 capsules per day: one with placebo and one with 0.40 mg folic acid from enrollment to delivery.
arm group label: Folic acid
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Zhao Gengli, MD
role: Principal Investigator
affiliation: Peking University First Hospital
facility: 
country: China
responsible party type: Sponsor-Investigator
investigator affiliation: Peking University First Hospital
investigator full name: Zhao gengli
investigator title: Associate Professor
mesh term: Anemia, Iron-Deficiency
mesh term: Iron Deficiencies
mesh term: Folic Acid
mesh term: Vitamin B Complex