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Effect of Branch Chain Amino Acid Therapy on Sarcopenia in Children With Chronic Liver Disease.

NCT05093218 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2021-11-03

No results posted yet for this study

Summary

Sarcopenia is now a well-known complication of cirrhosis and various studies, including pediatric studies, have recognized it as a poor prognostic factor. At the molecular level, branch chain amino acids upregulate muscle protein synthesis by acting through the mTOR pathway. Although effect of Branch Chain Amino acids has been studied extensively with respect to hepatic encephalopathy in cirrhotic adults, there is paucity of literature on the effect of BCAA on sarcopenia and frailty. Also, there is very limited data on the effect of BCAA therapy in children with chronic liver disease. Through this study, we aim to assess the effect of BCAA therapy on Mid Arm Muscle Area in cirrhotic children after 12 weeks. Our secondary objective will be to study the prevalence of sarcopenia in children with CLD using cut-off as Mid Arm Muscle area less than 2SD (using published centiles) and muscle thickness (quadriceps and biceps) on ultrasound, and to study serum follistatin levels in those with or without sarcopenia. Other secondary objectives will include determination of mTOR gene expression at baseline and 7 days of BCAA therapy and change in creatinine height index after 12 weeks of BCAA therapy, occurrence of clinically significant events in the BCAA group vs placebo group and to study the increase in MAMA and USG muscle thickness after 6 months of BCAA therapy.

Conditions

Interventions

DIETARY_SUPPLEMENT

branch chain amino acid

• Branch chain amino acid at a dose of approxiametely 0.35g/kg will be supplemented in two divided doses group for a period of 12 weeks.For the sake of administration, it will be prescribed as per the following weight band categories: \<5kg 2 gm 5-10kg 4 gm 10-20kg 8 gm 20-40kg 12 gm 40-60kg 24 gm

OTHER

placebo

Placebo will have the similar colour, taste and consistency. Both groups will be given the same dose.

Sponsors & Collaborators

  • Institute of Liver and Biliary Sciences, India

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-31
Primary Completion
2023-03-05
Completion
2023-03-05

Countries

  • India

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05093218 on ClinicalTrials.gov