<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/NCT03293641</url>
  </required_header>
  <id_info>
    <org_study_id>KEMRI SSC 2925</org_study_id>
    <nct_id>NCT03293641</nct_id>
  </id_info>
  <brief_title>Zinc Supplementation in Children With Sickle Cell Disease in Western Kenya</brief_title>
  <official_title>The Effects of Zinc Supplementation in Children With Sickle Cell Disease in Western Kenya: a Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lucas Otieno Tina, MD MSc</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>GlaxoSmithKline</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Strathmore University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Kenya Medical Research Institute</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>
      Zinc is a nutritionally essential trace element found in previous studies to reduce growth&#xD;
      retardation and improve immune function, which may also result in decreased incidence of&#xD;
      infectious diseases including malaria, pneumonia and diarrhea. Sickle Cell Disease (SCD)&#xD;
      patients are known to be susceptible to zinc deficiency and appear to benefit from zinc&#xD;
      supplementation. The proposed pilot research project aims to investigate the influence of&#xD;
      zinc supplementation on incidence of malaria infections, incidence of bacterial infections&#xD;
      and investigate the influence of zinc supplementation on morbidity in children with SCD in&#xD;
      western Kenya. The differences in incidence of morbidity and other secondary endpoints will&#xD;
      be compared between the zinc group and the control group.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Zinc is a nutritionally essential trace element found in previous studies to reduce growth&#xD;
      retardation and improve immune function, which may also result in decreased incidence of&#xD;
      infectious diseases including malaria, pneumonia and diarrhea. SCD patients are known to be&#xD;
      susceptible to zinc deficiency and appear to benefit from zinc supplementation. Despite these&#xD;
      findings, SCD patients in Kenya have not benefited from zinc supplementation programs due to&#xD;
      a lack of research and findings to inform policy in the East African-setting. The proposed&#xD;
      pilot research project aims to investigate the influence of zinc supplementation on incidence&#xD;
      of malaria infections in children with SCD; investigate the influence of zinc supplementation&#xD;
      on incidence of bacterial infections (e.g. S pneumoniae, H influenzae and non-typhi&#xD;
      Salmonella species) in children with SCD and investigate the influence of zinc&#xD;
      supplementation on morbidity in children with SCD in western Kenya. A 6 month randomized&#xD;
      controlled pilot trial involving children with SCD aged 6 months to less than 13 years, being&#xD;
      treated and followed up routinely at the KEMRI-site and other selected health facilities in&#xD;
      Western Kenya for SCD will be enrolled. The children will be randomized into two arms, with&#xD;
      the Intervention Group receiving the recommended Ministry of Health (MoH)/World Health&#xD;
      Organization (WHO) standard care in addition to three times weekly zinc supplementation (10&#xD;
      mg) and the Control Group receiving standard MoH care alone over a six month period. At&#xD;
      baseline, at 3 months and at 6 months, clinical and laboratory evaluations, including serum&#xD;
      zinc levels, malaria blood slides, anthropometric measurements and other indicated laboratory&#xD;
      tests will be conducted.The differences in incidence of morbidity and other secondary&#xD;
      endpoints will be compared between the zinc group and the control group. The results are&#xD;
      expected to determine the scientific basis for a larger clinical trial to determine the need&#xD;
      for the addition of zinc supplement to the management of sickle cell disease.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 20, 2016</start_date>
  <completion_date type="Actual">January 19, 2017</completion_date>
  <primary_completion_date type="Actual">January 19, 2017</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>
    <intervention_model_description>Randomized Controlled Pilot Trial in which children aged 6 months to less than 13 years were randomized on a ration of 1:1 to receive the Zinc plus Standard of Care versus Standard of Care Management for Sickle Cell Disease</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Measurement of change in zinc levels from baseline at study conclusion.</measure>
    <time_frame>6 months</time_frame>
    <description>Zinc Levels in Plasma</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of malaria episodes among recipients of zinc versus controls diagnosed by RDT or Microscopy.</measure>
    <time_frame>6 months</time_frame>
    <description>Malaria Incidence</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of episodes of bacterial infections among recipients of zinc versus controls diagnosed by culture.</measure>
    <time_frame>6 months</time_frame>
    <description>Bacterial Infection Incidence</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of malnutrition among recipients of zinc versus controls diagnosed based on anthropometric measurements.</measure>
    <time_frame>6 months</time_frame>
    <description>Anthropometric Measurements i.e. Weight, Height and Mid Upper Arm Circumference</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occurrences of Adverse Events (AEs) during the 6 month follow-up period among recipients of zinc versus controls.</measure>
    <time_frame>6 months</time_frame>
    <description>Adverse Events including Serious Adverse Events</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Sickle Cell Disease</condition>
  <condition>Zinc Deficiency</condition>
  <condition>Infection</condition>
  <arm_group>
    <arm_group_label>Zinc Sulfate Tablet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Zinc Sulfate Tablet 10 mg, 3 times a week plus Standard of Care for 6 months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Arm</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Standard of Care for 6 months</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Zinc Sulfate Tablets</intervention_name>
    <description>Zinc Sulfate Tablets 3 times every 7 days for 6 months.</description>
    <arm_group_label>Zinc Sulfate Tablet</arm_group_label>
    <other_name>Zincos</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Standard of Care</intervention_name>
    <description>Folic Acid, Proguanil, Penicillin V, Hydroxyurea over 6 months</description>
    <arm_group_label>Control Arm</arm_group_label>
    <arm_group_label>Zinc Sulfate Tablet</arm_group_label>
    <other_name>Folic Acid, Proguanil, Penicillin V, Hydroxyurea</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female infants and children ≥ 6 months and &lt; 13 years of age with confirmed&#xD;
             SCD.&#xD;
&#xD;
          -  Written informed consent obtained from the participant's parent/Legally Acceptable&#xD;
             Representative (LAR).&#xD;
&#xD;
          -  Available to participate for the study duration (approximately six months)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Written informed consent NOT obtained from the participant's parent/Legally Acceptable&#xD;
             Representative (LAR).&#xD;
&#xD;
          -  Profound clinical evidence of current immunosuppression or evidence of active AIDS&#xD;
             defining illness i.e. WHO HIV clinical stage III/IV&#xD;
&#xD;
          -  History of allergic reactions to zinc or any other ingredients in the supplement&#xD;
&#xD;
          -  History of any neurologic disorders or seizures&#xD;
&#xD;
          -  Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic, renal&#xD;
             functional abnormality, as determined by physical examination or laboratory screening&#xD;
             tests&#xD;
&#xD;
          -  Hemoglobin ≤7.0 g/dL in children aged 6 months to ≤ 2 years.&#xD;
&#xD;
          -  Hemoglobin ≤ 6 g/dL in children aged &gt;2yrs to &lt;13 years.&#xD;
&#xD;
          -  Total White Cell Count below normal range &lt;4.5 x 103/uL&#xD;
&#xD;
          -  Use of any investigational or non-registered drugs or vaccines or planned use&#xD;
&#xD;
          -  Simultaneous participation in any other clinical trial&#xD;
&#xD;
          -  Any other findings that the investigator feels would increase the risk of having an&#xD;
             adverse outcome from participation in the trial.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Months</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lucas O Tina, MD MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>KEMRI/CREATES, Strathmore University</affiliation>
  </overall_official>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>April 14, 2017</study_first_submitted>
  <study_first_submitted_qc>September 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 26, 2017</study_first_posted>
  <last_update_submitted>September 25, 2017</last_update_submitted>
  <last_update_submitted_qc>September 25, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 26, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Kenya Medical Research Institute</investigator_affiliation>
    <investigator_full_name>Lucas Otieno Tina, MD MSc</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Children, Sickle Cell Disease, Zinc</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anemia, Sickle Cell</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>Penicillins</mesh_term>
    <mesh_term>Penicillin V</mesh_term>
    <mesh_term>Proguanil</mesh_term>
    <mesh_term>Hydroxyurea</mesh_term>
    <mesh_term>Zinc Sulfate</mesh_term>
  </intervention_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/NCT03293641
org study id: KEMRI SSC 2925
nct id: NCT03293641
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Zinc is a nutritionally essential trace element found in previous studies to reduce growth
      retardation and improve immune function, which may also result in decreased incidence of
      infectious diseases including malaria, pneumonia and diarrhea. Sickle Cell Disease (SCD)
      patients are known to be susceptible to zinc deficiency and appear to benefit from zinc
      supplementation. The proposed pilot research project aims to investigate the influence of
      zinc supplementation on incidence of malaria infections, incidence of bacterial infections
      and investigate the influence of zinc supplementation on morbidity in children with SCD in
      western Kenya. The differences in incidence of morbidity and other secondary endpoints will
      be compared between the zinc group and the control group.
Zinc is a nutritionally essential trace element found in previous studies to reduce growth
      retardation and improve immune function, which may also result in decreased incidence of
      infectious diseases including malaria, pneumonia and diarrhea. SCD patients are known to be
      susceptible to zinc deficiency and appear to benefit from zinc supplementation. Despite these
      findings, SCD patients in Kenya have not benefited from zinc supplementation programs due to
      a lack of research and findings to inform policy in the East African-setting. The proposed
      pilot research project aims to investigate the influence of zinc supplementation on incidence
      of malaria infections in children with SCD; investigate the influence of zinc supplementation
      on incidence of bacterial infections (e.g. S pneumoniae, H influenzae and non-typhi
      Salmonella species) in children with SCD and investigate the influence of zinc
      supplementation on morbidity in children with SCD in western Kenya. A 6 month randomized
      controlled pilot trial involving children with SCD aged 6 months to less than 13 years, being
      treated and followed up routinely at the KEMRI-site and other selected health facilities in
      Western Kenya for SCD will be enrolled. The children will be randomized into two arms, with
      the Intervention Group receiving the recommended Ministry of Health (MoH)/World Health
      Organization (WHO) standard care in addition to three times weekly zinc supplementation (10
      mg) and the Control Group receiving standard MoH care alone over a six month period. At
      baseline, at 3 months and at 6 months, clinical and laboratory evaluations, including serum
      zinc levels, malaria blood slides, anthropometric measurements and other indicated laboratory
      tests will be conducted.The differences in incidence of morbidity and other secondary
      endpoints will be compared between the zinc group and the control group. The results are
      expected to determine the scientific basis for a larger clinical trial to determine the need
      for the addition of zinc supplement to the management of sickle cell disease.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized Controlled Pilot Trial in which children aged 6 months to less than 13 years were randomized on a ration of 1:1 to receive the Zinc plus Standard of Care versus Standard of Care Management for Sickle Cell Disease
primary purpose: Prevention
masking: None (Open Label)
measure: Measurement of change in zinc levels from baseline at study conclusion.
time frame: 6 months
description: Zinc Levels in Plasma
measure: Number of malaria episodes among recipients of zinc versus controls diagnosed by RDT or Microscopy.
time frame: 6 months
description: Malaria Incidence
measure: Number of episodes of bacterial infections among recipients of zinc versus controls diagnosed by culture.
time frame: 6 months
description: Bacterial Infection Incidence
measure: Incidence of malnutrition among recipients of zinc versus controls diagnosed based on anthropometric measurements.
time frame: 6 months
description: Anthropometric Measurements i.e. Weight, Height and Mid Upper Arm Circumference
measure: Occurrences of Adverse Events (AEs) during the 6 month follow-up period among recipients of zinc versus controls.
time frame: 6 months
description: Adverse Events including Serious Adverse Events
arm group label: Zinc Sulfate Tablet
arm group type: Experimental
description: Zinc Sulfate Tablet 10 mg, 3 times a week plus Standard of Care for 6 months
arm group label: Control Arm
arm group type: Placebo Comparator
description: Standard of Care for 6 months
intervention type: Dietary Supplement
intervention name: Zinc Sulfate Tablets
description: Zinc Sulfate Tablets 3 times every 7 days for 6 months.
arm group label: Zinc Sulfate Tablet
other name: Zincos
intervention type: Drug
intervention name: Standard of Care
description: Folic Acid, Proguanil, Penicillin V, Hydroxyurea over 6 months
arm group label: Control Arm
arm group label: Zinc Sulfate Tablet
other name: Folic Acid, Proguanil, Penicillin V, Hydroxyurea
criteria: 
gender: All
minimum age: 6 Months
maximum age: 12 Years
healthy volunteers: No
last name: Lucas O Tina, MD MSc
role: Principal Investigator
affiliation: KEMRI/CREATES, Strathmore University
responsible party type: Sponsor-Investigator
investigator affiliation: Kenya Medical Research Institute
investigator full name: Lucas Otieno Tina, MD MSc
investigator title: Principal Investigator
mesh term: Anemia, Sickle Cell
mesh term: Folic Acid
mesh term: Penicillins
mesh term: Penicillin V
mesh term: Proguanil
mesh term: Hydroxyurea
mesh term: Zinc Sulfate
sharing ipd: No