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OpenTrials
Completed

NCT Number: NCT02023229

Branched Chain Aminoacid Supplementation in Patients With Liver Cirrhosis

Malnutrition is a frequent complication in patients with liver cirrhosis. Most patients have decreased dietary intake due to ascites, hepatic encephalopathy and pro-inflammatory cytokines.

We hypothesized that branched chain aminoacids can improve nutritional status and delay episodes of hepatic encephalopathy

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Key information

Conditions

Liver Cirrhosis Brain Diseases Brain Diseases, Metabolic Central Nervous System Diseases Digestive System Diseases Fibrosis Hepatic Encephalopathy Hepatic Insufficiency Liver Diseases Liver Failure Metabolic Diseases Nervous System Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Instituto Nacional de Ciencias Médicas y Nutrición "Salvador Zubirán"

Mexico City, 14000, Mexico

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Ambulatory patients Patients with confirmed diagnose of liver cirrhosis Patients classified as Child-Pugh A or Child Pugh B

Exclusion criteria

Acute or chronic renal failure Pregnancy Overt hepatic encephalopathy

Treatment and study plan

Branched-chain aminoacids

Dietary Supplement

High-fiber high protein diet

Other

Primary outcomes

  1. Nutritional status

    Time frame: At time of recruitment

    Assessed by bioelectrical impedance vector analysis and mid-arm muscle circumference

Secondary outcomes

  1. Hepatic Encephalopathy

    Time frame: At time of recruitment

Other outcomes

  1. Nutritional status

    Time frame: 3 months follow-up

    Assessed by bioelectrical impedance vector analysis and mid-arm muscle circumference

  2. Nutritional status

    Time frame: 6 months follow-up

    Assessed by bioelectrical impedance vector analysis and mid-arm muscle circumference

  3. Hepatic encephalopathy

    Time frame: 6 months follow-up

Sponsors and collaborators

Lead sponsor

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Other

Registry information

Official study title

High-fiber High-fiber Diet and Branched Chain Aminoacids. Impact on Nutritional Status and Complications in Patients With Liver Cirrhosis

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Dec 30, 2013
Registry last updated
Dec 30, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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