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Safety and Efficacy of Propionate for Reduction of LDL Cholesterol (PROPER-LDL)

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ClinicalTrials.gov Identifier: NCT03590496
Recruitment Status : Recruiting
First Posted : July 18, 2018
Last Update Posted : September 6, 2018
Sponsor:
Information provided by (Responsible Party):
Arash Haghikia, Charite University, Berlin, Germany

Tracking Information
First Submitted Date  ICMJE July 6, 2018
First Posted Date  ICMJE July 18, 2018
Last Update Posted Date September 6, 2018
Actual Study Start Date  ICMJE November 21, 2017
Estimated Primary Completion Date November 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 17, 2018)
LDL-cholesterol reduction [ Time Frame: 8 weeks ]
mg/dL
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03590496 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 17, 2018)
  • total cholesterol [ Time Frame: 8 weeks ]
    mg/dL
  • HDL-cholesterol [ Time Frame: 8 weeks ]
    mg/dL
  • non HDL [ Time Frame: 8 weeks ]
    mg/dL
  • Ratio HDL/LDL [ Time Frame: 8 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of Propionate for Reduction of LDL Cholesterol
Official Title  ICMJE Safety and Efficacy of PROPionatE for Reduction of LDL Cholesterol (PROPER-LDL Trial) - A Phase 2 Randomized Placebo Controlled Double-blind Trial
Brief Summary The objective of the trial is to evaluate a potential impact of food supplements with the short chain fatty acid propionate on blood LDL cholesterol level.
Detailed Description 124 patients with hypercholesterolemia (LDL serum level > 115 mg/dl) will be enrolled. 62 patients with moderate cardiovascular risk will be 1:1 randomized to receive either Placebo (b.i.d.) or 500mg of propionate (b.i.d.) in addition to their basic cholesterol lowering treatment with 10mg Atorvastatin per day. Another 62 patients with low cardiovascular risk will be 1:1 randomized to receive either placebo (b.i.d.) or 500mg of propionate (b.i.d.). The primary endpoint is the change (delta) in blood LDL cholesterol levels after 8 weeks.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Hypercholesterolemia
Intervention  ICMJE
  • Drug: Atorvastatin 10mg
    Atorvastatin-Calcium Film-coated tablets
  • Dietary Supplement: Calcium-Propionate 500mg
    Calcium-Propionate capsules
  • Other: Placebo
    Placebo capsules without any active ingredient
Study Arms  ICMJE
  • Active Comparator: Arm 1
    31 patients will be treated with 500mg Calcium-Propionate capsules (twice a day) in addition to their basic cholesterol lowering therapy with 10mg Atorvastatin (once per day) for 8 weeks.
    Interventions:
    • Drug: Atorvastatin 10mg
    • Dietary Supplement: Calcium-Propionate 500mg
  • Placebo Comparator: Arm 2
    31 patients will be treated with placebo capsules (twice a day) in addition to their basic cholesterol lowering therapy with 10mg Atorvastatin (once per day) for 8 weeks.
    Interventions:
    • Drug: Atorvastatin 10mg
    • Other: Placebo
  • Active Comparator: Arm 3
    31 patients will be treated with 500mg Calcium-Propionate capsules (twice a day) for 8 weeks.
    Intervention: Dietary Supplement: Calcium-Propionate 500mg
  • Placebo Comparator: Arm 4
    31 patients will be treated with placebo capsules (twice a day) for 8 weeks.
    Intervention: Other: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 17, 2018)
124
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 30, 2020
Estimated Primary Completion Date November 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • patients with hypercholestrolemia and a LDL serum level of > 115 mg/dl
  • age of patient between 20 and 70 years
  • participant is fully competent and has given his/her written informed consent to the scheduled trial conduct

Exclusion Criteria:

  • patients with acute coronary syndrome in the last 4 weeks
  • patients with chronic symptomatic heart failure (NYHA 2-4)
  • patients with chronic renal failure and a GFR < 45 ml/min
  • patients with chronic liver disease
  • patients with hematological diseases
  • patients with severe diseases of other organ systems (tumors, infections)
  • pregnancy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Arash Haghikia, PD MD (0)30450513797 ext +49 arash.haghikia@charite.de
Contact: Paul Schumann, PhD candidate (0)30450513807 ext +49 paul.schumann@charite.de
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03590496
Other Study ID Numbers  ICMJE PROPER-LDL Trial
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Arash Haghikia, Charite University, Berlin, Germany
Study Sponsor  ICMJE Charite University, Berlin, Germany
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Arash Haghikia, PD MD Charite University, Berlin, Germany
PRS Account Charite University, Berlin, Germany
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP