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/NCT05969327</url>
    </required_header>
    <id_info>
      <org_study_id>MD 438/ 2017</org_study_id>
      <nct_id>NCT05969327</nct_id>
    </id_info>
    <brief_title>Role of Vitamin D Therapy in Recovery From Early Neonatal Sepsis (Randomized Controlled Trial)</brief_title>
    <official_title>Role of Vitamin D Therapy in Recovery From Early Neonatal Sepsis (Randomized Controlled Trial)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Ain Shams University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Ain Shams University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Neonatal sepsis is still a major cause of morbidity and mortality despite major advances in&#xD;
        neonatal intensive care units. Early-onset sepsis (EOS) is an infection of the blood acquired&#xD;
        vertically from the mother and manifests shortly after birth. The objective of this study is&#xD;
        to assess the vitamin D status in neonates with Early onset sepsis (EOS) and evaluate the&#xD;
        influence of different doses of vitamin D3 (800 IU/d versus 400 IU/d), in these infants.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Subjects:&#xD;
  &#xD;
        This is a randomized controlled trial (RCT) conducted on sixty (66) full term newborns with&#xD;
        clinical and laboratory findings of early onset of sepsis (EOS) and admitted to the Neonatal&#xD;
        Intensive Care Unit of El-Demerdash hospital of Ain Shams university and El Ahrar teaching&#xD;
        hospital in Zagazig.&#xD;
  &#xD;
          -  Inclusion Criteria: full term newborns with clinical and laboratory findings of early&#xD;
             onset of sepsis (EOS).&#xD;
  &#xD;
          -  Exclusion Criteria: Preterm newborn, NPO neonates , infants with maternal risk factors ,&#xD;
             such as clinical and/or histological chorioamnionitis, neonates delivered at home&#xD;
             ,neonates to mothers with premature rupture of membrane, and major congenital&#xD;
             abnormalities which may be predisposing factors for development of EOS.&#xD;
  &#xD;
        NB: we excluded the dead cases (6 cases) in the final laboratory and clinical relation with&#xD;
        serum Vitamin D levels after recovery because sepsis caused death to these neonates and&#xD;
        recovery didn't occur .&#xD;
  &#xD;
        Methods:&#xD;
  &#xD;
        An informed consent was taken from the legal guardian of the newborns participating in the&#xD;
        study.&#xD;
  &#xD;
        Detailed history taking from all mothers of neonates in the study laying stress on vitamin D&#xD;
        supplementation during pregnancy, sun exposure in mothers during pregnancy, place and mode of&#xD;
        delivery. Dietetic history in all included mothers (National Nutrition institute, 2006).&#xD;
        Clinical evaluation of all newborns for signs of neonatal sepsis.&#xD;
  &#xD;
        All subjects in the study were subjected to the following:&#xD;
  &#xD;
          1. Clinical Examination: General examination including vital data; temperature, pulse,&#xD;
             respiratory rate, anthropometric measurements including weight and length (Neonatal&#xD;
             Anthropometry): In all neonates weight (in Kg) was recorded on an electronic weighing&#xD;
             scale at birth. Length (in cm) was recorded by measuring tape.&#xD;
  &#xD;
             SDS of weight and length was calculated and plotted against appropriate growth curves&#xD;
             (Tanner et al., 1968).&#xD;
  &#xD;
          2. Laboratory Investigations: Under aseptic conditions venous blood samples was collected&#xD;
             into sterile blood collection tubes and the following investigations was performed:&#xD;
  &#xD;
               -  A neonatal sepsis screen including: total leukocyte count, absolute neutrophil&#xD;
                  count, platelet count immature to total neutrophil count and C-reactive protein&#xD;
                  (CRP).&#xD;
  &#xD;
               -  Blood samples for complete blood count (CBC) and blood culture. All patients were&#xD;
                  initially assessed according to Newborn Scale of Sepsis.&#xD;
  &#xD;
                    -  A total clinical score less than 10 indicated that the newborn did not have&#xD;
                       sepsis-a negative predictive value of 97%.&#xD;
  &#xD;
                    -  Any neonate with a total clinical score greater than 10 was considered&#xD;
                       ''sick,'' possibly with sepsis. A clinical score greater than 10 is also an&#xD;
                       indicator of the need for further diagnostic evaluation (Gardner, 2008).&#xD;
  &#xD;
               -  Serum 25 (OH) vitamin D levels: was measured by Human Vitamin D ELISA Kit (Qualpro&#xD;
                  diagnostics, INDIA) in all newborns on the first day of sepsis, 25(OH) vitamin D&#xD;
                  levels were classified according to the guidelines of the Endocrine Society to the&#xD;
                  following reference values:&#xD;
  &#xD;
               -  Sufficient &gt;20 ng/ml (&gt;50 nmol/l)&#xD;
  &#xD;
               -  Insufficient 12-20 ng/ml (30-50 nmol/l)&#xD;
  &#xD;
               -  Deficient &lt;12 ng/ml (&lt;30 nmol/l) (Munns et al., 2016).&#xD;
  &#xD;
        Study design : Subjects were classified into three groups :&#xD;
  &#xD;
        GROUP A (conventional dose Vitamin D) those neonates who received a daily dose of oral&#xD;
        Vitamin D of 400 IU through Ryle or mouth from onset of diagnosis till recovery from sepsis.&#xD;
  &#xD;
        GROUP B (higher dose Vitamin D) those neonates who receiveda daily dose of oral vitamin D of&#xD;
        800 IU through ryle or mouth from onset of diagnosis till recovery from sepsis.&#xD;
  &#xD;
        GROUP C (Placebo group) those neonates with early onset sepsis who did not receive any&#xD;
        vitamin D supplementation.&#xD;
  &#xD;
        Patients were matched regarding sepsis score. All 3 groups were treated using strategy of&#xD;
        sepsis treatment.&#xD;
  &#xD;
          -  Reevaluation of serum Vitamin D levels for all patients on recovery(recovery was&#xD;
             assessed by Newborn Scale of Sepsis to be less than 10).&#xD;
  &#xD;
          -  Serum Ca and P were measured initially for all patients upon diagnosis of EOS, and on&#xD;
             discharge upon recovery Normal range of Ca 8.8-11.3mg/dl Normal range P 4.5-6.2 mg/dl&#xD;
  &#xD;
          -  Urinary Ca will be evaluated after two weeks of onset of vitamin D therapy (for patients&#xD;
             who experience elevation of serum Ca above normal value).&#xD;
  &#xD;
        Type of Study: Randomized controlled study. Study Setting: This study was conducted on sixty&#xD;
        (66) full term newborns with clinical and laboratory findings of early onset of sepsis (EOS)&#xD;
        and were admitted to the Neonatal Intensive Care Unit of El-Demerdash hospital of Ain Shams&#xD;
        university and El Ahrar teaching hospital in Zagazig.&#xD;
  &#xD;
          -  Study Period: The study took place from January 2018 to January 2021.&#xD;
  &#xD;
          -  Study Population: Full term newborns with early onset sepsis.&#xD;
  &#xD;
          -  Sampling Method: random.&#xD;
  &#xD;
          -  Sample Size:&#xD;
  &#xD;
        Using PASS program, setting alpha error at 5% and power at 80%. After reviewing literature,&#xD;
        no previous similar study has been done before. So assuming that NICU duration for placebo,&#xD;
        400IU vitamin D and 800 IU vitamin D respectively is 7±2.5, 5.5±2.5, 4±2.5 based on this, the&#xD;
        needed sample is 20 cases per group (total 60).&#xD;
  &#xD;
        • Ethical Considerations:&#xD;
  &#xD;
          -  The consent was conducted to the legal guardian or the parents of our patients by the&#xD;
             investigator.&#xD;
  &#xD;
          -  Premature termination of oral vitamin D was mandatory for patients with abdominal&#xD;
             distension or feeding intolerance.&#xD;
  &#xD;
          -  All data was treated confidentially and was not be allowed except to the principle&#xD;
             investigator.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">August 14, 2018</start_date>
    <completion_date type="Actual">December 27, 2022</completion_date>
    <primary_completion_date type="Actual">September 6, 2022</primary_completion_date>
    <phase>Phase 3</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Factorial Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Participant, Care Provider)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Role of Vitamin D therapy in recovery from Early Neonatal Sepsis (randomized controlled trial)</measure>
      <time_frame>nearly 4 years</time_frame>
      <description>supplementation of Vitamin D</description>
    </primary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Actual">66</enrollment>
    <condition>Importance of Vitamin D Therapy in Treatment of Neonatal Sepsis</condition>
    <arm_group>
      <arm_group_label>with out vitamin D</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>neonates without supplementation</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Vitamin D 400 IU</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>neonates with 400 IU supplementation</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Vitamin D 800 IU</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>neonates with 800 IU supplementation</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Vitamin D</intervention_name>
      <description>oral supplementation of two different doses</description>
      <arm_group_label>Vitamin D 400 IU</arm_group_label>
      <arm_group_label>Vitamin D 800 IU</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  -Inclusion Criteria: full term newborns with clinical and laboratory findings of early&#xD;
               onset of sepsis (EOS).&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Preterm newborn, NPO neonates , infants with maternal risk factors , such as clinical&#xD;
               and/or histological chorioamnionitis, neonates delivered at home ,neonates to mothers&#xD;
               with premature rupture of membrane, and major congenital abnormalities which may be&#xD;
               predisposing factors for development of EOS.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>3 Days</minimum_age>
      <maximum_age>7 Days</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Mayada Ahmad Mohamed</name>
        <address>
          <city>Zagazig</city>
          <country>Egypt</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>December 2017</verification_date>
    <study_first_submitted>July 23, 2023</study_first_submitted>
    <study_first_submitted_qc>July 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>August 22, 2023</last_update_submitted>
    <last_update_submitted_qc>August 22, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 24, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Sepsis</mesh_term>
      <mesh_term>Toxemia</mesh_term>
      <mesh_term>Neonatal Sepsis</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Vitamin D</mesh_term>
    </intervention_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/NCT05969327
  org study id: MD 438/ 2017
  nct id: NCT05969327
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Neonatal sepsis is still a major cause of morbidity and mortality despite major advances in
        neonatal intensive care units. Early-onset sepsis (EOS) is an infection of the blood acquired
        vertically from the mother and manifests shortly after birth. The objective of this study is
        to assess the vitamin D status in neonates with Early onset sepsis (EOS) and evaluate the
        influence of different doses of vitamin D3 (800 IU/d versus 400 IU/d), in these infants.
  Subjects:
  
        This is a randomized controlled trial (RCT) conducted on sixty (66) full term newborns with
        clinical and laboratory findings of early onset of sepsis (EOS) and admitted to the Neonatal
        Intensive Care Unit of El-Demerdash hospital of Ain Shams university and El Ahrar teaching
        hospital in Zagazig.
  
          -  Inclusion Criteria: full term newborns with clinical and laboratory findings of early
             onset of sepsis (EOS).
  
          -  Exclusion Criteria: Preterm newborn, NPO neonates , infants with maternal risk factors ,
             such as clinical and/or histological chorioamnionitis, neonates delivered at home
             ,neonates to mothers with premature rupture of membrane, and major congenital
             abnormalities which may be predisposing factors for development of EOS.
  
        NB: we excluded the dead cases (6 cases) in the final laboratory and clinical relation with
        serum Vitamin D levels after recovery because sepsis caused death to these neonates and
        recovery didn't occur .
  
        Methods:
  
        An informed consent was taken from the legal guardian of the newborns participating in the
        study.
  
        Detailed history taking from all mothers of neonates in the study laying stress on vitamin D
        supplementation during pregnancy, sun exposure in mothers during pregnancy, place and mode of
        delivery. Dietetic history in all included mothers (National Nutrition institute, 2006).
        Clinical evaluation of all newborns for signs of neonatal sepsis.
  
        All subjects in the study were subjected to the following:
  
          1. Clinical Examination: General examination including vital data; temperature, pulse,
             respiratory rate, anthropometric measurements including weight and length (Neonatal
             Anthropometry): In all neonates weight (in Kg) was recorded on an electronic weighing
             scale at birth. Length (in cm) was recorded by measuring tape.
  
             SDS of weight and length was calculated and plotted against appropriate growth curves
             (Tanner et al., 1968).
  
          2. Laboratory Investigations: Under aseptic conditions venous blood samples was collected
             into sterile blood collection tubes and the following investigations was performed:
  
               -  A neonatal sepsis screen including: total leukocyte count, absolute neutrophil
                  count, platelet count immature to total neutrophil count and C-reactive protein
                  (CRP).
  
               -  Blood samples for complete blood count (CBC) and blood culture. All patients were
                  initially assessed according to Newborn Scale of Sepsis.
  
                    -  A total clinical score less than 10 indicated that the newborn did not have
                       sepsis-a negative predictive value of 97%.
  
                    -  Any neonate with a total clinical score greater than 10 was considered
                       ''sick,'' possibly with sepsis. A clinical score greater than 10 is also an
                       indicator of the need for further diagnostic evaluation (Gardner, 2008).
  
               -  Serum 25 (OH) vitamin D levels: was measured by Human Vitamin D ELISA Kit (Qualpro
                  diagnostics, INDIA) in all newborns on the first day of sepsis, 25(OH) vitamin D
                  levels were classified according to the guidelines of the Endocrine Society to the
                  following reference values:
  
               -  Sufficient >20 ng/ml (>50 nmol/l)
  
               -  Insufficient 12-20 ng/ml (30-50 nmol/l)
  
               -  Deficient <12 ng/ml (<30 nmol/l) (Munns et al., 2016).
  
        Study design : Subjects were classified into three groups :
  
        GROUP A (conventional dose Vitamin D) those neonates who received a daily dose of oral
        Vitamin D of 400 IU through Ryle or mouth from onset of diagnosis till recovery from sepsis.
  
        GROUP B (higher dose Vitamin D) those neonates who receiveda daily dose of oral vitamin D of
        800 IU through ryle or mouth from onset of diagnosis till recovery from sepsis.
  
        GROUP C (Placebo group) those neonates with early onset sepsis who did not receive any
        vitamin D supplementation.
  
        Patients were matched regarding sepsis score. All 3 groups were treated using strategy of
        sepsis treatment.
  
          -  Reevaluation of serum Vitamin D levels for all patients on recovery(recovery was
             assessed by Newborn Scale of Sepsis to be less than 10).
  
          -  Serum Ca and P were measured initially for all patients upon diagnosis of EOS, and on
             discharge upon recovery Normal range of Ca 8.8-11.3mg/dl Normal range P 4.5-6.2 mg/dl
  
          -  Urinary Ca will be evaluated after two weeks of onset of vitamin D therapy (for patients
             who experience elevation of serum Ca above normal value).
  
        Type of Study: Randomized controlled study. Study Setting: This study was conducted on sixty
        (66) full term newborns with clinical and laboratory findings of early onset of sepsis (EOS)
        and were admitted to the Neonatal Intensive Care Unit of El-Demerdash hospital of Ain Shams
        university and El Ahrar teaching hospital in Zagazig.
  
          -  Study Period: The study took place from January 2018 to January 2021.
  
          -  Study Population: Full term newborns with early onset sepsis.
  
          -  Sampling Method: random.
  
          -  Sample Size:
  
        Using PASS program, setting alpha error at 5% and power at 80%. After reviewing literature,
        no previous similar study has been done before. So assuming that NICU duration for placebo,
        400IU vitamin D and 800 IU vitamin D respectively is 7±2.5, 5.5±2.5, 4±2.5 based on this, the
        needed sample is 20 cases per group (total 60).
  
        • Ethical Considerations:
  
          -  The consent was conducted to the legal guardian or the parents of our patients by the
             investigator.
  
          -  Premature termination of oral vitamin D was mandatory for patients with abdominal
             distension or feeding intolerance.
  
          -  All data was treated confidentially and was not be allowed except to the principle
             investigator.
  allocation: Randomized
  intervention model: Factorial Assignment
  primary purpose: Treatment
  masking: Double (Participant, Care Provider)
  measure: Role of Vitamin D therapy in recovery from Early Neonatal Sepsis (randomized controlled trial)
  time frame: nearly 4 years
  description: supplementation of Vitamin D
  arm group label: with out vitamin D
  arm group type: No Intervention
  description: neonates without supplementation
  arm group label: Vitamin D 400 IU
  arm group type: Experimental
  description: neonates with 400 IU supplementation
  arm group label: Vitamin D 800 IU
  arm group type: Experimental
  description: neonates with 800 IU supplementation
  intervention type: Drug
  intervention name: Vitamin D
  description: oral supplementation of two different doses
  arm group label: Vitamin D 400 IU
  arm group label: Vitamin D 800 IU
  criteria: 
  gender: All
  minimum age: 3 Days
  maximum age: 7 Days
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  country: Egypt
  responsible party type: Sponsor
  mesh term: Sepsis
  mesh term: Toxemia
  mesh term: Neonatal Sepsis
  mesh term: Vitamin D