The Effect of Calcium β-hydroxy-β-methylbutyrate (CaHMB) Supplementation in Sarcopenia in Liver Cirrhosis

Last updated: September 25, 2018
Sponsor: Shanghai Zhongshan Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Sarcopenia

Scar Tissue

Hyponatremia

Treatment

N/A

Clinical Study ID

NCT03605147
CIR-CAHMB-001
  • Ages 18-75
  • All Genders

Study Summary

This study is to evaluate the effect of CaHMB in the treatment of sarcopenia in liver cirrhosis.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. diagnosed of cirrhosis with imaging or liver biopsy;

  2. diagnosis of portal hypertension with endoscopy or radiography;

  3. assessed total muscle mass at the level of L3 (<42 cm2/m2 for male and <38 cm2/m2 forfemale)

  4. has signed an informed consent form.

Exclusion

Exclusion Criteria:

  1. diagnosed as hepatic cell cancer;

  2. complicated with malignancy, renal failure, diabetes mellitus;

  3. comorbidities including heart failure or pulmonary disease;

  4. current use of drugs that affect skeletal muscle metabolism;

  5. be allergic to the experimental food;

  6. participated other clinical trials in the past 3 months;

  7. other conditions that researchers consider not suitable for this study

Study Design

Total Participants: 120
Study Start date:
August 22, 2018
Estimated Completion Date:
July 31, 2019

Study Description

The study is a randomized double-blind controlled trial. Patients randomly enter into two treatment groups: 1) the CaHMB group and 2) the placebo group. Treatment allocation is by block randomization, with an one-to-one ratio for CaHMB and placebo. The results are concealed in opaque envelopes. Patients will report their daily diets with an online software. Patients will come for clinic after 4 weeks and 12 weeks, receiving laboratory tests and sarcopenia evaluation, and events of primary and secondary outcomes will be analyzed.

Connect with a study center

  • Shanghai Zhongshan Hospital

    Shanghai, Shanghai 200032
    China

    Active - Recruiting

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