<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/NCT02993874</url>
  </required_header>
  <id_info>
    <org_study_id>Creatine PAD</org_study_id>
    <nct_id>NCT02993874</nct_id>
  </id_info>
  <brief_title>Creatine Supplementation in Patients With Intermittent Claudication.</brief_title>
  <official_title>Effect of Creatine Supplementation Associated to Clinical Treatment of the Functional Capacity of Patients With Intermittent Claudication.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>State University of Maringá</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Fundação de Amparo à Pesquisa do Estado do Amazonas</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>State University of Maringá</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study will be to verify the effect of creatine supplementation associated to&#xD;
      clinical treatment of the functional capacity in patients with intermittent claudication.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of this study will be to verify the effect of creatine supplementation associated to&#xD;
      clinical treatment of the functional capacity in patients with intermittent claudication. The&#xD;
      sample will be composed by patients with intermittent claudication of both sexes. The&#xD;
      patients will be ramdomized in a double-blind procedure to receive during seven days&#xD;
      (loading) and posteriorly 49 days (maintenance) a creatine (Cr) supplementation or placebo&#xD;
      (PLA), associated to the clinical treatment. Before (&quot;baseline&quot;), after &quot;loading&quot; period and&#xD;
      after the maintenance period of supplementation, the patients will go through a functional&#xD;
      capacity evaluation. The fuctional capacity evaluation will be evaluated by a six&#xD;
      minute-walking test. For statistical analysis it will be used the ANOVA of two factors for&#xD;
      repeated measurements, having the (Cr and PLA) group and the time (pre, post-loading and&#xD;
      post-maintenance), and when needed the post-hoc of Newman keuls. The adopted level of&#xD;
      significance will be P&lt;0.05.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 26, 2017</start_date>
  <completion_date type="Anticipated">June 2019</completion_date>
  <primary_completion_date type="Anticipated">February 2019</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change walking capacity</measure>
    <time_frame>Baseline, one and eight weeks</time_frame>
    <description>The walking capacity will be assessed through a six-minute walk test, before and after one week (Loading - 7 days) and after 7 weeks of supplementation (Maintenance - 49 days) in both groups (Cr and PLA).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change oxygen saturation</measure>
    <time_frame>Baseline, one and eight weeks</time_frame>
    <description>Oxygen saturation will be assessed on calf region during the six-minute walk test through Near-infrared spectroscopy (NIRS, PortaMon, Artinis Medical Systems) before, after one week (Loading - 7 days) and after 7 weeks of supplementation (Maintenance - 49 days) in both groups (Cr and PLA).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change Short Physical Performance Battery</measure>
    <time_frame>Baseline, one and eight weeks</time_frame>
    <description>Functional capacity will be assessed through a Short Physical Performance Battery test, after one week (Loading - 7 days) and after 7 weeks of supplementation (Maintenance - 49 days) in both groups (Cr and PLA).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change cognitive function</measure>
    <time_frame>Baseline, one and eight weeks</time_frame>
    <description>For cognitive aspetcs evaluation the following procedures will be taken: Stroop test (Victoria Stroop test and N-Back (Operational Memory) will performed after one week (Loading - 7 days) and after 7 weeks of supplementation (Maintenance - 49 days) in both groups (Cr and PLA).</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change brachial blood pressure.</measure>
    <time_frame>Baseline, one and eight weeks</time_frame>
    <description>Brachial blood pressure will be assessed through an automatic monitor (HEM-742, Omron Healthcare, Japan) before, after one week (Loading - 7 days) and after 7 weeks of supplementation (Maintenance - 49 days) in both groups (Cr and PLA).</description>
  </other_outcome>
  <other_outcome>
    <measure>Change arterial stiffness</measure>
    <time_frame>Baseline, one and eight weeks</time_frame>
    <description>The arterial stiffness will be evaluated by the applanation tonometry method (SphygmoCor, AtCor Medical, Australia) before, after one week (Loading - 7 days) and after 7 weeks of supplementation (Maintenance - 49 days) in both groups (Cr and PLA).</description>
  </other_outcome>
  <other_outcome>
    <measure>Change autonomic cardiac modulation</measure>
    <time_frame>Baseline, one and eight weeks</time_frame>
    <description>The autonomic cardiac modulation will be evaluated through a heart rate monitor (Polar, RS 800, USA) after one week (Loading - 7 days) and after 7 weeks of supplementation (Maintenance - 49 days) in both groups (Cr and PLA).</description>
  </other_outcome>
  <other_outcome>
    <measure>Change vasodilatory capacity</measure>
    <time_frame>Baseline and eight weeks</time_frame>
    <description>Vasodilatation capacity will be assessed by ultrasound imaging (HDI 5000 Sono CT, Philips, The Netherlands) after one week (Loading - 7 days) and after 7 weeks of supplementation (Maintenance - 49 days) in both groups ( Cr and PLA).</description>
  </other_outcome>
  <other_outcome>
    <measure>Change body composition</measure>
    <time_frame>Baseline and eight weeks</time_frame>
    <description>Body composition will be evaluated after one week (Loading - 7 days) and after 7 weeks of supplementation (Maintenance - 49 days) in both groups (Cr and PLA) using the bio-electrical bioimpedance method (BIS 4200B Xitron Technologies, Inc, San Diego, PLA).</description>
  </other_outcome>
  <other_outcome>
    <measure>Creatine plasma</measure>
    <time_frame>Baseline, one and eight weeks</time_frame>
    <description>Creatine plasma will be evaluated by the High Performance Liquid Chromatography (HPLC) method (FL SPD-20A Shimadzu®, Kyoto, Japan), after one week (loading - 7 days) and after 7 weeks of supplementation (maintenance - 49 days) in both The groups (Cr and PLA).</description>
  </other_outcome>
  <other_outcome>
    <measure>Change of Renal function markers</measure>
    <time_frame>Baseline, one and eight weeks</time_frame>
    <description>serum creatinine,creatinine excretion rate and creatinine clearance. Urine will be collected during the 24-hour period, neglecting the first collection. For the measurement of the urinary volume, beakers of 500 to 1000 ml were used. Blood and urinary creatinine levels were determined by the Jaffé method without deproteinization.</description>
  </other_outcome>
  <other_outcome>
    <measure>Food habits</measure>
    <time_frame>Baseline, one and eight weeks</time_frame>
    <description>For food intake evaluation a 24-hour food diary will be required by previously trained nutritionists, using the nutritional evaluation program Avanutry 3.1.4</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">90</enrollment>
  <condition>Intermittent Claudication</condition>
  <arm_group>
    <arm_group_label>Creatine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Creatine monohydrate (Cr) Loading - 4 doses of 5g / day for 7 days Maintenance - 1 dose of 3g / day for 49 days Clinical treatment (30-45 minutes of walking, 3 times per week)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Dextrose Loading - 4 doses of 5g / day for 7 days Maintenance - 1 dose of 3g / day for 49 days Clinical treatment (30-45 minutes of walking, 3 times per week)</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Creatine</intervention_name>
    <description>The experimental group will ingest for seven days (Loading - phase 1), 5g (4x/day) of creatine monohydrate associated with the clinical treatment (30-45 minutes of walking, 3 times a week). Subsequently, they will ingest for 49 days (Maintenance - phase 2), 3g (1x / day) creatine monohydrate associated with clinical treatment (30-45 minutes of walking, 3 times a week). They will be given guidance by telephone, so that they can reach the necessary recommendations for the study.</description>
    <arm_group_label>Creatine</arm_group_label>
    <other_name>Creatine and clinical treatment</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>The placebo group will ingest for seven days (Loading - phase 1), 5g (4x / day) of dextrose associated to clinical treatment (30-45 minutes of walking, 3 times per week). Subsequently, they will ingest for 49 days (Maintenance phase 2), 3g (1x / day) of dextrose associated with the clinical treatment (30-45 minutes of walking, 3 times a week). They will be given guidance by telephone, so that they can reach the necessary recommendations for the study.</description>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>Placebo and clinical treatment</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  symptom of pain during the six-minute walk test limited by leg pain due to&#xD;
             intermittent claudication.&#xD;
&#xD;
          -  present peripheral artery disease (Ankle-arm index &lt; 0.90) in one or both limbs.&#xD;
&#xD;
          -  Asymptomatic intermittent claudication determined from the clinical history.&#xD;
&#xD;
          -  Not have muscle or joint injuries that make it impossible to practice physical&#xD;
             activity.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  not attending more than 15% of the intervention sessions or visits to the laboratory.&#xD;
&#xD;
          -  Stick to a physical activity program in addition to that offered by the study.&#xD;
&#xD;
          -  do not use medication regularly.&#xD;
&#xD;
          -  aggravation of the disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ademar Avelar, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>State University of Maringa</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Raphael Ritti-Dias, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Israel Institute of Education and Research Albert Einstein</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Gabriel Cucato, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Israel Institute of Education and Research Albert Einstein</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ademar Avelar, PhD</last_name>
    <phone>5544984376050</phone>
    <email>ademaravelar@yahoo.com.br</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Wagner Domingues, MD</last_name>
    <phone>5511982841355</phone>
    <email>wagnerfef@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Israel Institute of Education and Research Albert Einstein</name>
      <address>
        <city>Sao Paulo</city>
        <zip>05652900</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Wagner Domingues, MD</last_name>
      <phone>5511982841355</phone>
      <email>wagnerfef@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>December 12, 2016</study_first_submitted>
  <study_first_submitted_qc>December 12, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 15, 2016</study_first_posted>
  <last_update_submitted>February 19, 2019</last_update_submitted>
  <last_update_submitted_qc>February 19, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 21, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>State University of Maringá</investigator_affiliation>
    <investigator_full_name>Ademar Avelar de Almeida Junior</investigator_full_name>
    <investigator_title>PhD</investigator_title>
  </responsible_party>
  <keyword>Ergonemic resources</keyword>
  <keyword>Walking capacity</keyword>
  <keyword>Peripheral artery disease</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Intermittent Claudication</mesh_term>
  </condition_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/NCT02993874
org study id: Creatine PAD
nct id: NCT02993874
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The aim of this study will be to verify the effect of creatine supplementation associated to
      clinical treatment of the functional capacity in patients with intermittent claudication.
The aim of this study will be to verify the effect of creatine supplementation associated to
      clinical treatment of the functional capacity in patients with intermittent claudication. The
      sample will be composed by patients with intermittent claudication of both sexes. The
      patients will be ramdomized in a double-blind procedure to receive during seven days
      (loading) and posteriorly 49 days (maintenance) a creatine (Cr) supplementation or placebo
      (PLA), associated to the clinical treatment. Before ("baseline"), after "loading" period and
      after the maintenance period of supplementation, the patients will go through a functional
      capacity evaluation. The fuctional capacity evaluation will be evaluated by a six
      minute-walking test. For statistical analysis it will be used the ANOVA of two factors for
      repeated measurements, having the (Cr and PLA) group and the time (pre, post-loading and
      post-maintenance), and when needed the post-hoc of Newman keuls. The adopted level of
      significance will be P<0.05.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Change walking capacity
time frame: Baseline, one and eight weeks
description: The walking capacity will be assessed through a six-minute walk test, before and after one week (Loading - 7 days) and after 7 weeks of supplementation (Maintenance - 49 days) in both groups (Cr and PLA).
measure: Change oxygen saturation
time frame: Baseline, one and eight weeks
description: Oxygen saturation will be assessed on calf region during the six-minute walk test through Near-infrared spectroscopy (NIRS, PortaMon, Artinis Medical Systems) before, after one week (Loading - 7 days) and after 7 weeks of supplementation (Maintenance - 49 days) in both groups (Cr and PLA).
measure: Change Short Physical Performance Battery
time frame: Baseline, one and eight weeks
description: Functional capacity will be assessed through a Short Physical Performance Battery test, after one week (Loading - 7 days) and after 7 weeks of supplementation (Maintenance - 49 days) in both groups (Cr and PLA).
measure: Change cognitive function
time frame: Baseline, one and eight weeks
description: For cognitive aspetcs evaluation the following procedures will be taken: Stroop test (Victoria Stroop test and N-Back (Operational Memory) will performed after one week (Loading - 7 days) and after 7 weeks of supplementation (Maintenance - 49 days) in both groups (Cr and PLA).
measure: Change brachial blood pressure.
time frame: Baseline, one and eight weeks
description: Brachial blood pressure will be assessed through an automatic monitor (HEM-742, Omron Healthcare, Japan) before, after one week (Loading - 7 days) and after 7 weeks of supplementation (Maintenance - 49 days) in both groups (Cr and PLA).
measure: Change arterial stiffness
time frame: Baseline, one and eight weeks
description: The arterial stiffness will be evaluated by the applanation tonometry method (SphygmoCor, AtCor Medical, Australia) before, after one week (Loading - 7 days) and after 7 weeks of supplementation (Maintenance - 49 days) in both groups (Cr and PLA).
measure: Change autonomic cardiac modulation
time frame: Baseline, one and eight weeks
description: The autonomic cardiac modulation will be evaluated through a heart rate monitor (Polar, RS 800, USA) after one week (Loading - 7 days) and after 7 weeks of supplementation (Maintenance - 49 days) in both groups (Cr and PLA).
measure: Change vasodilatory capacity
time frame: Baseline and eight weeks
description: Vasodilatation capacity will be assessed by ultrasound imaging (HDI 5000 Sono CT, Philips, The Netherlands) after one week (Loading - 7 days) and after 7 weeks of supplementation (Maintenance - 49 days) in both groups ( Cr and PLA).
measure: Change body composition
time frame: Baseline and eight weeks
description: Body composition will be evaluated after one week (Loading - 7 days) and after 7 weeks of supplementation (Maintenance - 49 days) in both groups (Cr and PLA) using the bio-electrical bioimpedance method (BIS 4200B Xitron Technologies, Inc, San Diego, PLA).
measure: Creatine plasma
time frame: Baseline, one and eight weeks
description: Creatine plasma will be evaluated by the High Performance Liquid Chromatography (HPLC) method (FL SPD-20A Shimadzu®, Kyoto, Japan), after one week (loading - 7 days) and after 7 weeks of supplementation (maintenance - 49 days) in both The groups (Cr and PLA).
measure: Change of Renal function markers
time frame: Baseline, one and eight weeks
description: serum creatinine,creatinine excretion rate and creatinine clearance. Urine will be collected during the 24-hour period, neglecting the first collection. For the measurement of the urinary volume, beakers of 500 to 1000 ml were used. Blood and urinary creatinine levels were determined by the Jaffé method without deproteinization.
measure: Food habits
time frame: Baseline, one and eight weeks
description: For food intake evaluation a 24-hour food diary will be required by previously trained nutritionists, using the nutritional evaluation program Avanutry 3.1.4
arm group label: Creatine
arm group type: Experimental
description: Creatine monohydrate (Cr) Loading - 4 doses of 5g / day for 7 days Maintenance - 1 dose of 3g / day for 49 days Clinical treatment (30-45 minutes of walking, 3 times per week)
arm group label: Placebo
arm group type: Placebo Comparator
description: Dextrose Loading - 4 doses of 5g / day for 7 days Maintenance - 1 dose of 3g / day for 49 days Clinical treatment (30-45 minutes of walking, 3 times per week)
intervention type: Dietary Supplement
intervention name: Creatine
description: The experimental group will ingest for seven days (Loading - phase 1), 5g (4x/day) of creatine monohydrate associated with the clinical treatment (30-45 minutes of walking, 3 times a week). Subsequently, they will ingest for 49 days (Maintenance - phase 2), 3g (1x / day) creatine monohydrate associated with clinical treatment (30-45 minutes of walking, 3 times a week). They will be given guidance by telephone, so that they can reach the necessary recommendations for the study.
arm group label: Creatine
other name: Creatine and clinical treatment
intervention type: Dietary Supplement
intervention name: Placebo
description: The placebo group will ingest for seven days (Loading - phase 1), 5g (4x / day) of dextrose associated to clinical treatment (30-45 minutes of walking, 3 times per week). Subsequently, they will ingest for 49 days (Maintenance phase 2), 3g (1x / day) of dextrose associated with the clinical treatment (30-45 minutes of walking, 3 times a week). They will be given guidance by telephone, so that they can reach the necessary recommendations for the study.
arm group label: Placebo
other name: Placebo and clinical treatment
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: No
last name: Ademar Avelar, PhD
role: Principal Investigator
affiliation: State University of Maringa
last name: Raphael Ritti-Dias, PhD
role: Study Director
affiliation: Israel Institute of Education and Research Albert Einstein
last name: Gabriel Cucato, PhD
role: Study Director
affiliation: Israel Institute of Education and Research Albert Einstein
last name: Ademar Avelar, PhD
phone: 5544984376050
email: ademaravelar@yahoo.com.br
last name: Wagner Domingues, MD
phone: 5511982841355
email: wagnerfef@gmail.com
facility: 
status: Recruiting
contact: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: State University of Maringá
investigator full name: Ademar Avelar de Almeida Junior
investigator title: PhD
mesh term: Intermittent Claudication