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/NCT05980026</url>
    </required_header>
    <id_info>
      <org_study_id>Ain shams Pediatrics 202021</org_study_id>
      <nct_id>NCT05980026</nct_id>
    </id_info>
    <brief_title>Omega-3 Fatty Acids Supplementation Improves Early-stage Diabetic Nephropathy and Subclinical Atherosclerosis in Pediatric Patients With Type 1 Diabetes</brief_title>
    <official_title>Omega-3 Fatty Acids Supplementation Improves Early-stage Diabetic Nephropathy and Subclinical Atherosclerosis in Pediatric Patients With Type 1 Diabetes</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>
        The investigators conducted this randomized-controlled trial to assess the effect of oral&#xD;
        omega-3 supplementation on glycemic control, lipid profile, albuminuria level, kidney injury&#xD;
        molecule-1 (KIM-1) and carotid intima media thickness (CIMT) to participants who were&#xD;
        pediatric patients with T1DM and diabetic nephropathy.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Management of diabetic kidney disease (DKD) mainly consists of correction of hyperglycemia,&#xD;
        hypertension and dyslipidemia as well as modification of lifestyle. Primary prevention&#xD;
        represents prevention from normoalbuminuria to microalbuminuria, while secondary prevention&#xD;
        represents prevention from microalbuminuria to macroalbuminuria. Multiple interventional&#xD;
        managements with control of blood glucose, blood pressure and lipid, and smoking cessation&#xD;
        can significantly improve the prognosis of cardiovascular events and slow down the&#xD;
        progression of renal disease.&#xD;
  &#xD;
        Omega-3 fatty acids are polyunsaturated fatty acids (PUFAs) derived from fish oil. Numerous&#xD;
        studies have evaluated the potential beneficial effects of omega-3 fatty acids on&#xD;
        inflammatory, autoimmune, and renal diseases. Due to their anti-inflammatory effects, omega-3&#xD;
        fatty acids have been suggested to protect against kidney damage. Omega-3 fatty acids can&#xD;
        reduce proteinuria in patients with chronic glomerular disease and slow immunoglobulin A&#xD;
        (IgA) nephropathy. However, the information about the effects of omega-3 fatty acids on&#xD;
        kidney function, particularly in diabetic kidney disease still lacks consensus .&#xD;
  &#xD;
        No previous study assessed the role of omega-3 fatty acids in diabetes associated&#xD;
        complications in particular diabetic nephropathy and subclinical atherosclerosis among&#xD;
        pediatric patients with T1DM and there is insufficient evidence to recommend its&#xD;
        supplementation for those patients. Therefore, the investigators conducted this study to&#xD;
        investigate the role of omega-3 fatty acids as an adjuvant therapy for participants who had&#xD;
        diabetic nephropathy in children and adolescents with T1DM and assess its relation glycemic&#xD;
        control, microalbuminuria, kidney injury molecule-1, lipid levels and carotid intima media&#xD;
        thickness as an index for subclinical atherosclerosis.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">January 10, 2022</start_date>
    <completion_date type="Actual">January 14, 2023</completion_date>
    <primary_completion_date type="Actual">December 17, 2022</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>Treatment</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>change in UACR (mg/g creatinine) level</measure>
      <time_frame>6 months</time_frame>
      <description>Urinary albumin excretion rate(mg/g creatinine)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>change in KIM-1 level (ng/mL)</measure>
      <time_frame>6 months</time_frame>
      <description>KIM-1 level((ng/mL)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>change in HbA1c(%)</measure>
      <time_frame>6 months</time_frame>
      <description>HbA1c%</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">70</enrollment>
    <condition>Diabetes Mellitus, Type 1</condition>
    <arm_group>
      <arm_group_label>oral omega-3 fatty acids supplementation</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Intervention group included pediatric patients with diabetic nephropathy receiving oral omega-3 fatty acids supplementation on a daily basis.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo comparator</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Placebo group or control patients received placebo that were similar in appearance to omega 3 fatty acids and the administered dose was as the same schedule as omega 3 fatty acids.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>oral omega-3 fatty acids supplementation</intervention_name>
      <description>oral omega-3 fatty acids supplementation</description>
      <arm_group_label>oral omega-3 fatty acids supplementation</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Patients in placebo group received placebo that were similar in appearance to omega 3 fatty acids and the administered dose was as the same schedule as omega 3 fatty acids.</description>
      <arm_group_label>Placebo comparator</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  patients with T1DM on regular insulin therapy.&#xD;
  &#xD;
            -  age from 12 to 18 years.&#xD;
  &#xD;
            -  disease duration at least 5 years.&#xD;
  &#xD;
            -  having diabetic nephropathy in the form of microalbuminuria (urinary albumin excretion&#xD;
               [UAE] 30-299 mg/g creatinine).&#xD;
  &#xD;
            -  hemoglobin A1c (HbA1c) ≤8.5% (69 mmol/mol).&#xD;
  &#xD;
            -  persistent microalbuminuria was confirmed by abnormal two or three urine samples over&#xD;
               a 3- to 6-months period prior to the study despite angiotensin converting enzyme&#xD;
               inhibitors (ACE-Is)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  patients with any clinical evidence of infection.&#xD;
  &#xD;
            -  patients with renal impairment due to causes other than diabetes.&#xD;
  &#xD;
            -  other diabetic complications than nephropathy.&#xD;
  &#xD;
            -  elevated liver enzymes.&#xD;
  &#xD;
            -  hyper- or hypo-thyroidism.&#xD;
  &#xD;
            -  intake of any vitamins or food supplements one month before study.&#xD;
  &#xD;
            -  participation in a previous investigational drug study within the three months&#xD;
               preceding screening.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <gender_based>Yes</gender_based>
      <minimum_age>12 Years</minimum_age>
      <maximum_age>18 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Nancy Elbarbary</name>
        <address>
          <city>Cairo</city>
          <zip>11361</zip>
          <country>Egypt</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 28, 2023</study_first_submitted>
    <study_first_submitted_qc>August 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 7, 2023</study_first_posted>
    <last_update_submitted>August 4, 2023</last_update_submitted>
    <last_update_submitted_qc>August 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Ain Shams University</investigator_affiliation>
      <investigator_full_name>Nancy Samir Elbarbary</investigator_full_name>
      <investigator_title>Prof. of Pediatrics</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Diabetic Nephropathies</mesh_term>
      <mesh_term>Atherosclerosis</mesh_term>
      <mesh_term>Diabetes Mellitus</mesh_term>
      <mesh_term>Diabetes Mellitus, Type 1</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
      <ipd_description>The data will be available on request</ipd_description>
    </patient_data>
    <!-- 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/NCT05980026
  org study id: Ain shams Pediatrics 202021
  nct id: NCT05980026
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The investigators conducted this randomized-controlled trial to assess the effect of oral
        omega-3 supplementation on glycemic control, lipid profile, albuminuria level, kidney injury
        molecule-1 (KIM-1) and carotid intima media thickness (CIMT) to participants who were
        pediatric patients with T1DM and diabetic nephropathy.
  Management of diabetic kidney disease (DKD) mainly consists of correction of hyperglycemia,
        hypertension and dyslipidemia as well as modification of lifestyle. Primary prevention
        represents prevention from normoalbuminuria to microalbuminuria, while secondary prevention
        represents prevention from microalbuminuria to macroalbuminuria. Multiple interventional
        managements with control of blood glucose, blood pressure and lipid, and smoking cessation
        can significantly improve the prognosis of cardiovascular events and slow down the
        progression of renal disease.
  
        Omega-3 fatty acids are polyunsaturated fatty acids (PUFAs) derived from fish oil. Numerous
        studies have evaluated the potential beneficial effects of omega-3 fatty acids on
        inflammatory, autoimmune, and renal diseases. Due to their anti-inflammatory effects, omega-3
        fatty acids have been suggested to protect against kidney damage. Omega-3 fatty acids can
        reduce proteinuria in patients with chronic glomerular disease and slow immunoglobulin A
        (IgA) nephropathy. However, the information about the effects of omega-3 fatty acids on
        kidney function, particularly in diabetic kidney disease still lacks consensus .
  
        No previous study assessed the role of omega-3 fatty acids in diabetes associated
        complications in particular diabetic nephropathy and subclinical atherosclerosis among
        pediatric patients with T1DM and there is insufficient evidence to recommend its
        supplementation for those patients. Therefore, the investigators conducted this study to
        investigate the role of omega-3 fatty acids as an adjuvant therapy for participants who had
        diabetic nephropathy in children and adolescents with T1DM and assess its relation glycemic
        control, microalbuminuria, kidney injury molecule-1, lipid levels and carotid intima media
        thickness as an index for subclinical atherosclerosis.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Participant)
  measure: change in UACR (mg/g creatinine) level
  time frame: 6 months
  description: Urinary albumin excretion rate(mg/g creatinine)
  measure: change in KIM-1 level (ng/mL)
  time frame: 6 months
  description: KIM-1 level((ng/mL)
  measure: change in HbA1c(%)
  time frame: 6 months
  description: HbA1c%
  arm group label: oral omega-3 fatty acids supplementation
  arm group type: Active Comparator
  description: Intervention group included pediatric patients with diabetic nephropathy receiving oral omega-3 fatty acids supplementation on a daily basis.
  arm group label: Placebo comparator
  arm group type: Placebo Comparator
  description: Placebo group or control patients received placebo that were similar in appearance to omega 3 fatty acids and the administered dose was as the same schedule as omega 3 fatty acids.
  intervention type: Drug
  intervention name: oral omega-3 fatty acids supplementation
  description: oral omega-3 fatty acids supplementation
  arm group label: oral omega-3 fatty acids supplementation
  intervention type: Dietary Supplement
  intervention name: Placebo
  description: Patients in placebo group received placebo that were similar in appearance to omega 3 fatty acids and the administered dose was as the same schedule as omega 3 fatty acids.
  arm group label: Placebo comparator
  criteria: 
  gender: All
  gender based: Yes
  minimum age: 12 Years
  maximum age: 18 Years
  healthy volunteers: No
  facility: 
  country: Egypt
  responsible party type: Principal Investigator
  investigator affiliation: Ain Shams University
  investigator full name: Nancy Samir Elbarbary
  investigator title: Prof. of Pediatrics
  mesh term: Diabetic Nephropathies
  mesh term: Atherosclerosis
  mesh term: Diabetes Mellitus
  mesh term: Diabetes Mellitus, Type 1
  sharing ipd: Undecided
  ipd description: The data will be available on request