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

NCT05093218 | Unknown

• 1 other identifier: ILBS-CLD-03
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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

Sarcopenia; Cirrhosis, Liver

Outcome Measures

Primary Outcomes (1)

• Change in Mid-arm muscle area (MAMA) after 12 weeks of BCAA therapy in children with CLD and sarcopenia (MAMA <2 SD).

  Mid-arm Muscle area (MAMA) is a measure of sarcopenia (muscle mass) and this we are assessing to know whether Branched chain amino-acid supplementation will influence muscle mass at 12 weeks. MAMA will be calculated from triceps skin fold thickness and Mid arm circumference using the formula, MAMA = \[(MAC - 3.14\*TSF)\^2\]/4\*3.14

  12 weeks

Secondary Outcomes (10)

• Change in mTOR gene expression levels after 7 days of BCAA therapy

  7 days

• Change in follistatin levels in children with CLD after 12 weeks of BCAA therapy.

  12 weeks

• Change in creatinine-height index after 12 weeks of BCAA therapy.

  12 weeks

• Change in MAMA (muscle size) after 6 months of BCAA therapy.

  6 months

• Change in muscle size (biceps and quadriceps) using ultrasound at 3 and 6 months.

  3 months

Study Arms (2)

branch chain amino acid

EXPERIMENTAL

• 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

Dietary Supplement: branch chain amino acid

placebo

PLACEBO COMPARATOR

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

Other: placebo

Interventions

branch chain amino acid DIETARY_SUPPLEMENT

• 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

branch chain amino acid

placebo OTHER

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

placebo

Eligibility Criteria

• Age: 6 Months - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children 6 mo - 12 y with cirrhosis and sarcopenia defined as MAMA \<2 SD for age

You may not qualify if:

• Non-cirrhotic Portal hypertension
• Suspected/proven malignancy
• Already on BCAA therapy in last 1 month
• Tyrosinemia
• Chronic kidney disease or non-resolving AKI
• Potential liver transplant within 1 month.

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institiute of liver and biliary sciences

New Delhi, 110070, India

RECRUITING

MeSH Terms

Conditions

Sarcopenia; Liver Cirrhosis

Interventions

Amino Acids

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes

Intervention Hierarchy (Ancestors)

Amino Acids, Peptides, and Proteins

Central Study Contacts

Prabhsaran Kaur, MD pediatrics

CONTACT

9833881739; prabhsaran.kaur@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2021
• First Posted: October 26, 2021
• Study Start: October 31, 2021
• Primary Completion: March 5, 2023
• Study Completion: March 5, 2023
• Last Updated: November 3, 2021

Record last verified: 2021-09

Locations

IN (1)