xml: <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/NCT05975125</url>
    </required_header>
    <id_info>
      <org_study_id>118/2566</org_study_id>
      <nct_id>NCT05975125</nct_id>
    </id_info>
    <brief_title>The Effect of Vitamin C for Iron Supplementation During Pregnancy With Risk of Anemia</brief_title>
    <official_title>The Effect of Vitamin C for Iron Supplementation During Pregnancy With Risk of Anemia</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Rajavithi Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Rajavithi Hospital</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        Anemia is a common problem during pregnancy. Most studies have demonstrated that anemia&#xD;
        during pregnancy have adverse effects on their pregnancy outcome, which is important and&#xD;
        should pay attention to prevent and solve such problems. The most common cause of anemia is&#xD;
        iron deficiency. Several studies reveal that Vitamin C promotes iron absorption. In this&#xD;
        study we will compare between Vitamin C with iron supplement and iron supplement alone in&#xD;
        prevention of anemia in pregnancy.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Anemia in pregnancy associated with Diabetes during pregnancy 15.9 % Fetal abnormalities in&#xD;
        blood oxygen causing fetal non reassuring 9.4% , Preterm delivery 8.2 %, Amniotic fluid&#xD;
        insufficiency 1.95 %, 10.6 % of infants had complications after birth, 9.7 % of infants were&#xD;
        hospitalized in intensive care units with birth weight less than 2,500 grams . (Low birth&#xD;
        weight) 4.9%, anemia also significantly increased the likelihood of blood transfusion during&#xD;
        pregnancy.&#xD;
  &#xD;
        There is also a study on the risk of developing anemia such as more than 2 pregnancies,&#xD;
        Teenage pregnancy, Advanced maternal age more than 35 years old, Mothers with a body mass&#xD;
        index below 18 are at increased risk of developing anemia. The most common cause of anemia&#xD;
        during pregnancy is iron deficiency. This may be caused by receiving the element. not enough&#xD;
        iron or there is a loss of iron from blood loss which is important and should pay attention&#xD;
        to prevent and solve such problems. Which Vitamin C promotes iron absorption. Vitamin C&#xD;
        combined with iron has been studied. It clearly increases hemoglobin and hematocrit. And is&#xD;
        safe for pregnant women and babies. There is also no evidence that vitamin C is a carcinogen,&#xD;
        or a cause of birth defects or toxicity. However, there are no studies related to the&#xD;
        combination of vitamin C and iron in pregnant women at risk of anemia. To solve the problem&#xD;
        and prevent the consequences of the above mentioned anemia. In this study we will compare&#xD;
        between Vitamin C with iron supplement and iron supplement alone in prevention of anemia in&#xD;
        pregnancy.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 28, 2023</start_date>
    <completion_date type="Anticipated">June 27, 2024</completion_date>
    <primary_completion_date type="Anticipated">June 27, 2024</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>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>To compare hemoglobin and hematocrit levels</measure>
      <time_frame>2 months after intervention</time_frame>
      <description>To compare hemoglobin and hematocrit levels between groups receiving vitamin C with iron and the group receiving only iron supplement</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>maternal and fetal pregnancy outcomes</measure>
      <time_frame>after intervention until delivery</time_frame>
      <description>To compare maternal and fetal pregnancy outcomes such as postpartum haemorrhage, blood transfusion after birth, birth body weight, gestational age at childbirth, the health of the baby after birth, etc., among the groups that received vitamin C and iron intake compare with the group that received only iron supplement alone.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>ratio of vitamin C</measure>
      <time_frame>2 months after intervention</time_frame>
      <description>To study the ratio of vitamin C and iron supplement in prevention of anemia in pregnancy.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>side effects after receiving vitamin C</measure>
      <time_frame>2 months after intervention</time_frame>
      <description>To study the side effects after receiving vitamin C during pregnancy.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Vitamin C Anemia</condition>
    <condition>Pregnancy Anemia</condition>
    <arm_group>
      <arm_group_label>Iron supplement with Vitamin C</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Vitamin C with Iron supplement&#xD;
  Drug:&#xD;
  Vitamin C 500mg Triferdine(Component: Iodine 0.15 mg, Iron 60.81 mg, Folic acid 0.4 mg)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Iron supplementation alone</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Iron supplement alone Drug: Triferdine Component: Iodine 0.15 mg, Iron 60.81 mg, Folic acid 0.4 mg</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Vitamin C 500 MG Oral Tablet</intervention_name>
      <description>compare between Vitamin C with iron supplement and iron supplement alone in prevention of anemia in pregnancy.</description>
      <arm_group_label>Iron supplement with Vitamin C</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Pregnant woman Antenatal care at Rajavithi Hospital&#xD;
  &#xD;
            2. Singleton pregnancy&#xD;
  &#xD;
            3. Provide inform consent with both patient and her husband&#xD;
  &#xD;
            4. Gestational age between 14-28 weeks&#xD;
  &#xD;
            5. Risk of anemia during pregnancy, including more than 2 pregnancies, teenage pregnancy,&#xD;
               advanced maternal age over 35 years old, mothers with body mass index below 18.&#xD;
  &#xD;
          5. Pregnant women with hemoglobin greater than 10.5 g/dL, hematocrit greater than 32 % in&#xD;
          the first antenatal blood results. 6. Giving birth at Rajavithi Hospital 7. Can communicate&#xD;
          and understand Thai language very well&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Receive vitamin C supplements during the program&#xD;
  &#xD;
            2. HIV infection&#xD;
  &#xD;
            3. Iron deficiency anemia or blood diseases such as thalassemia&#xD;
  &#xD;
            4. Gastrointestinal bleeding&#xD;
  &#xD;
            5. Antenatal hemorrhage&#xD;
  &#xD;
            6. Allergic to vitamin C or iron&#xD;
  &#xD;
            7. Congenital diseases including kidney disease, liver disease, joint disease and&#xD;
               bleeding disorders.&#xD;
  &#xD;
            8. Symptoms that indicate infection, such as fever, sore throat, sputum, diarrhea, loose&#xD;
               stools, etc.&#xD;
  &#xD;
            9. History of iron intake within the past 3 months&#xD;
  &#xD;
           10. Received blood components within the past 3 months or while participating in a&#xD;
               research project&#xD;
  &#xD;
           11. Giving birth during the drug trial&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <gender_description>Pregnant woman</gender_description>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Lalitpan Srimaneesiri, M.D.</last_name>
      <phone>0815645290</phone>
      <email>beamsish@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Lattaporn Pattanawichan, M.D.</last_name>
      <phone>081-4317833</phone>
      <email>eicky_lp@hotmail.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Rajavithi</name>
        <address>
          <city>Phaya Thai</city>
          <state>Ratchathewi</state>
          <zip>10400</zip>
          <country>Thailand</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location_countries>
      <country>Thailand</country>
    </location_countries>
    <verification_date>June 2023</verification_date>
    <study_first_submitted>July 27, 2023</study_first_submitted>
    <study_first_submitted_qc>July 27, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 3, 2023</study_first_posted>
    <last_update_submitted>July 27, 2023</last_update_submitted>
    <last_update_submitted_qc>July 27, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 3, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Vitamin C, Pregnancy with anemia</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Anemia</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05975125
  org study id: 118/2566
  nct id: NCT05975125
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  Anemia is a common problem during pregnancy. Most studies have demonstrated that anemia
        during pregnancy have adverse effects on their pregnancy outcome, which is important and
        should pay attention to prevent and solve such problems. The most common cause of anemia is
        iron deficiency. Several studies reveal that Vitamin C promotes iron absorption. In this
        study we will compare between Vitamin C with iron supplement and iron supplement alone in
        prevention of anemia in pregnancy.
  Anemia in pregnancy associated with Diabetes during pregnancy 15.9 % Fetal abnormalities in
        blood oxygen causing fetal non reassuring 9.4% , Preterm delivery 8.2 %, Amniotic fluid
        insufficiency 1.95 %, 10.6 % of infants had complications after birth, 9.7 % of infants were
        hospitalized in intensive care units with birth weight less than 2,500 grams . (Low birth
        weight) 4.9%, anemia also significantly increased the likelihood of blood transfusion during
        pregnancy.
  
        There is also a study on the risk of developing anemia such as more than 2 pregnancies,
        Teenage pregnancy, Advanced maternal age more than 35 years old, Mothers with a body mass
        index below 18 are at increased risk of developing anemia. The most common cause of anemia
        during pregnancy is iron deficiency. This may be caused by receiving the element. not enough
        iron or there is a loss of iron from blood loss which is important and should pay attention
        to prevent and solve such problems. Which Vitamin C promotes iron absorption. Vitamin C
        combined with iron has been studied. It clearly increases hemoglobin and hematocrit. And is
        safe for pregnant women and babies. There is also no evidence that vitamin C is a carcinogen,
        or a cause of birth defects or toxicity. However, there are no studies related to the
        combination of vitamin C and iron in pregnant women at risk of anemia. To solve the problem
        and prevent the consequences of the above mentioned anemia. In this study we will compare
        between Vitamin C with iron supplement and iron supplement alone in prevention of anemia in
        pregnancy.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: None (Open Label)
  measure: To compare hemoglobin and hematocrit levels
  time frame: 2 months after intervention
  description: To compare hemoglobin and hematocrit levels between groups receiving vitamin C with iron and the group receiving only iron supplement
  measure: maternal and fetal pregnancy outcomes
  time frame: after intervention until delivery
  description: To compare maternal and fetal pregnancy outcomes such as postpartum haemorrhage, blood transfusion after birth, birth body weight, gestational age at childbirth, the health of the baby after birth, etc., among the groups that received vitamin C and iron intake compare with the group that received only iron supplement alone.
  measure: ratio of vitamin C
  time frame: 2 months after intervention
  description: To study the ratio of vitamin C and iron supplement in prevention of anemia in pregnancy.
  measure: side effects after receiving vitamin C
  time frame: 2 months after intervention
  description: To study the side effects after receiving vitamin C during pregnancy.
  arm group label: Iron supplement with Vitamin C
  arm group type: Experimental
  description: Vitamin C with Iron supplement
  Drug:
  Vitamin C 500mg Triferdine(Component: Iodine 0.15 mg, Iron 60.81 mg, Folic acid 0.4 mg)
  arm group label: Iron supplementation alone
  arm group type: No Intervention
  description: Iron supplement alone Drug: Triferdine Component: Iodine 0.15 mg, Iron 60.81 mg, Folic acid 0.4 mg
  intervention type: Drug
  intervention name: Vitamin C 500 MG Oral Tablet
  description: compare between Vitamin C with iron supplement and iron supplement alone in prevention of anemia in pregnancy.
  arm group label: Iron supplement with Vitamin C
  criteria: 
  gender: Female
  gender based: Yes
  gender description: Pregnant woman
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Lalitpan Srimaneesiri, M.D.
  phone: 0815645290
  email: beamsish@gmail.com
  last name: Lattaporn Pattanawichan, M.D.
  phone: 081-4317833
  email: eicky_lp@hotmail.com
  facility: 
  status: Recruiting
  country: Thailand
  responsible party type: Sponsor
  mesh term: Anemia