<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/NCT03286673</url>
  </required_header>
  <id_info>
    <org_study_id>H28-06</org_study_id>
    <nct_id>NCT03286673</nct_id>
  </id_info>
  <brief_title>Comparison of Three Calcium Supplements</brief_title>
  <official_title>Comparison of Three Calcium Supplements With Regard to Their Metabolic Effects in Healthy Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Jena</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Jena</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study was conducted to investigate the metabolic effects of three different calcium&#xD;
      compounds in healthy adults.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2006</start_date>
  <completion_date type="Actual">March 2007</completion_date>
  <primary_completion_date type="Actual">March 2007</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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Serum mineral concentration</measure>
    <time_frame>after 4 weeks of each intervention</time_frame>
    <description>Calcium and Phosphate (and others) concentration in serum.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Stool mineral concentration</measure>
    <time_frame>after 4 weeks of each intervention</time_frame>
    <description>Calcium and Phosphate concentration (and others) in stool from a three day stool collection</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Urine mineral concentration</measure>
    <time_frame>after 4 weeks of each intervention</time_frame>
    <description>Calcium and Phosphate concentration (and others) in urine from a three day urine collection</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Lipids in blood</measure>
    <time_frame>after 4 weeks of each intervention</time_frame>
    <description>Lipids and lipoprotein concentration in serum.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Sterols</measure>
    <time_frame>after 4 weeks of each intervention</time_frame>
    <description>Neutrals sterols and bile acids in stool from a three day stool collection</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Dietary intake</measure>
    <time_frame>after 4 weeks of each intervention</time_frame>
    <description>Evaluation of the dietary intake using a three day weighed dietary record.</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">31</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>calcium phosphate</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Pentacalcium hydroxy-triphosphate (Ca5(PO4)3OH) was incorporated in wholemeal and crispy wafer bread in order to achieve a additional calcium intake of 1000 mg/d.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Tricalcium Phosphate</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>β-tricalcium phosphate (Ca3(PO4)2) as incorporated in wholemeal and crispy wafer bread in order to achieve a additional calcium intake of 1000 mg/d.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Calcium carbonate</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Calcium carbonate (CaCO3) was incorporated in wholemeal and crispy wafer bread in order to achieve a additional calcium intake of 1000 mg/d.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Wholemeal and crispy wafer bread without additional calcium additive.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>calcium phosphate</intervention_name>
    <arm_group_label>calcium phosphate</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Tricalcium Phosphate</intervention_name>
    <arm_group_label>Tricalcium Phosphate</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Calcium carbonate</intervention_name>
    <arm_group_label>Calcium carbonate</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age 18 - 40 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  diseases of the gastrointestinal tract&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  the intake of any medication (e. g. for thyroid gland)&#xD;
&#xD;
          -  intake of dietary supplements&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gerhard Jahreis, Prof. Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Friedrich Schiller University Jena, Institute of Nutrition</affiliation>
  </overall_official>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 11, 2017</study_first_submitted>
  <study_first_submitted_qc>September 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 18, 2017</study_first_posted>
  <last_update_submitted>September 13, 2017</last_update_submitted>
  <last_update_submitted_qc>September 13, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 18, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Jena</investigator_affiliation>
    <investigator_full_name>Gerhard Jahreis</investigator_full_name>
    <investigator_title>Prof. Dr. Gerhard Jahreis</investigator_title>
  </responsible_party>
  <keyword>calcium carbonate</keyword>
  <keyword>calcium phosphate</keyword>
  <keyword>metabolic effects</keyword>
  <keyword>human study</keyword>
  <keyword>calcium and phosphorus metabolism</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Calcium, Dietary</mesh_term>
    <mesh_term>Calcium Carbonate</mesh_term>
    <mesh_term>Calcium</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/NCT03286673
org study id: H28-06
nct id: NCT03286673
lead sponsor: 
has dmc: No
The study was conducted to investigate the metabolic effects of three different calcium
      compounds in healthy adults.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Serum mineral concentration
time frame: after 4 weeks of each intervention
description: Calcium and Phosphate (and others) concentration in serum.
measure: Stool mineral concentration
time frame: after 4 weeks of each intervention
description: Calcium and Phosphate concentration (and others) in stool from a three day stool collection
measure: Urine mineral concentration
time frame: after 4 weeks of each intervention
description: Calcium and Phosphate concentration (and others) in urine from a three day urine collection
measure: Lipids in blood
time frame: after 4 weeks of each intervention
description: Lipids and lipoprotein concentration in serum.
measure: Sterols
time frame: after 4 weeks of each intervention
description: Neutrals sterols and bile acids in stool from a three day stool collection
measure: Dietary intake
time frame: after 4 weeks of each intervention
description: Evaluation of the dietary intake using a three day weighed dietary record.
arm group label: calcium phosphate
arm group type: Experimental
description: Pentacalcium hydroxy-triphosphate (Ca5(PO4)3OH) was incorporated in wholemeal and crispy wafer bread in order to achieve a additional calcium intake of 1000 mg/d.
arm group label: Tricalcium Phosphate
arm group type: Experimental
description: β-tricalcium phosphate (Ca3(PO4)2) as incorporated in wholemeal and crispy wafer bread in order to achieve a additional calcium intake of 1000 mg/d.
arm group label: Calcium carbonate
arm group type: Experimental
description: Calcium carbonate (CaCO3) was incorporated in wholemeal and crispy wafer bread in order to achieve a additional calcium intake of 1000 mg/d.
arm group label: Placebo
arm group type: Active Comparator
description: Wholemeal and crispy wafer bread without additional calcium additive.
intervention type: Dietary Supplement
intervention name: calcium phosphate
arm group label: calcium phosphate
intervention type: Dietary Supplement
intervention name: Tricalcium Phosphate
arm group label: Tricalcium Phosphate
intervention type: Dietary Supplement
intervention name: Calcium carbonate
arm group label: Calcium carbonate
intervention type: Dietary Supplement
intervention name: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Gerhard Jahreis, Prof. Dr.
role: Principal Investigator
affiliation: Friedrich Schiller University Jena, Institute of Nutrition
responsible party type: Principal Investigator
investigator affiliation: University of Jena
investigator full name: Gerhard Jahreis
investigator title: Prof. Dr. Gerhard Jahreis
mesh term: Calcium, Dietary
mesh term: Calcium Carbonate
mesh term: Calcium
sharing ipd: No