Clinical trial NCT02297997: Preventive Effects of Cetylpyridinium Chloride on SarcopeniaStudy
Official title: Randomized, Double Blinded, Placebo-controlled Trial to Assess the Preventive Effects of Cetylpyridinium Chloride on Sarcopenia: An Exploratory Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Sarcopenia
Keywords: sarcopenia
cetylpyridinium chloride
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2014-11-21
Enrollment: 65
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study is to assess the impact on the prevention of sarcopenia after taking cetylpyridinium chloride targeting the patients of presarcopenia over the age of 60.

Detailed description: 65 people that meet the inclusion criteria on screening test are assigned to one of five groups by randomization. They take the medication for two weeks under double-blind. Four study groups take cetylpyridinium chloride of 1.5mg, 3mg, 4.5mg and 6mg daily for two weeks. Control group takes the placebo for the same period. The main outcome variables are measured and compared respectively in baseline, immediately after dosing end and two weeks after the end of administration. Finally cetylpyridinium chloride is verified whether it has a preventive effect on sarcopenia and set an appropriate dose.

Eligibility criteria: Inclusion Criteria:

* Presarcopenia A. Reduced skeletal muscle mass (ASM/height2) M \< 7.0kg/m2, F \< 5.7kg/m2 B. Normal grip strength M ≥ 26kg, F ≥ 18kg C. Normal physical performance Gait speed \> 0.8m/s
* Community dwelling

Exclusion Criteria:

* History of stroke or spinal cord injury
* Artificial joint
* Acute disease or unstable chronic disease
* Phenylketonuria
* History of myocardiac infarction
* Allergic contact dermatitis
* History of drug/alcohol addiction, habitual smoker

Primary outcomes:
measure: Change from baseline in procollagen type III N-terminal peptide
timeFrame: baseline, immediately after dosing end, two weeks after the end of administration
measure: Change from baseline in myostatin
timeFrame: baseline, immediately after dosing end, two weeks after the end of administration
measure: Change from baseline in TNF-α
timeFrame: baseline, immediately after dosing end, two weeks after the end of administration
measure: Change from baseline in IL-6
timeFrame: baseline, immediately after dosing end, two weeks after the end of administration
measure: Change from baseline in urinary creatinine
timeFrame: baseline, immediately after dosing end, two weeks after the end of administration
Secondary outcomes:
measure: Change from baseline in CRP
timeFrame: baseline, immediately after dosing end, two weeks after the end of administration
measure: Change from baseline in Hemoblobin
timeFrame: baseline, immediately after dosing end, two weeks after the end of administration
measure: Change from baseline in Albumin
timeFrame: baseline, immediately after dosing end, two weeks after the end of administration
measure: Change from baseline in Vitamin D
timeFrame: baseline, immediately after dosing end, two weeks after the end of administration
Other outcomes:
Locations:
Study officials:
affiliation: Seoul National University College of Medicine
name: Sun Gun Chung, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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