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Effect of Branch Chain Amino Acid therapy on muscle mass in children with chronic liver disease

Effect of Branch Chain Amino Acid supplementation on sarcopenia in children with chronic liver disease- A double blinded placebo controlled randomised control trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/11/038012
Enrollment
44
Registered
2021-11-12
Start date
Unknown
Completion date
Unknown
Last updated
2022-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K746- Other and unspecified cirrhosis ofliver

Interventions

Intervention1: Branch chain amino acid: Branch chain amino acid at a dose of approxiametely 0.35g per kg will be supplemented in two divided doses group for a period of 12 weeks.For the sake of admini

Sponsors

ILBS
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Children 6 mo â?? 12 y with cirrhosis and sarcopenia defined as MAMA <2 SD for age

Exclusion criteria

Exclusion criteria: • 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.

Design outcomes

Primary

MeasureTime frame
Change in Mid-arm muscle area (MAMA) after 12 weeks of BCAA therapy in children with CLD and sarcopenia (MAMA 2 SD). Timepoint: 12 weeks—

Secondary

MeasureTime frame
Change in mTOR gene expression levels after 7 days of BCAA therapy Timepoint: 7 days;Change in muscle size (biceps and quadriceps) using ultrasound at 3 and 6 months.Timepoint: 3 and 6 months;Change in the occurrence of significant events including HE, UGI bleed, SBP, AKI, new onset or increase in ascites, hospital stay and mortalityTimepoint: 3 and 6 months;Change in Albumin requirement in the BCAA groupTimepoint: 3 and 6 months;Change in creatinine-height index after 12 weeks of BCAA therapy. Timepoint: 12 weeks;Change in follistatin levels in children with CLD after 12 weeks of BCAA therapy. Timepoint: 12 weeks;Change in MAMA (muscle size) after 6 months of BCAA therapy. Timepoint: 6 months—

Countries

India

Contacts

Public ContactDr Rajeev Khanna

ILBS

drrajeev_khanna@rediffmail.com9654246963

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026