Effect of Branched-chain Amino Acids (BCAA) to Muscle Cramps in Patients With Cirrhosis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Change of muscle cramp frequency
研究概览
简要总结
The goal of this randomized controlled trial is to compare the efficacy and safety of branched-chain amino acids (BCAA) versus placebo for treating muscle cramps in cirrhotic patients. The main questions it aims to answer are:
- Compared the effect of BCAA versus placebo on muscle cramp frequency in cirrhotic patients
- Compared the effect of BCAA versus placebo on muscle cramp duration and severity in cirrhotic patients
- Compared the effect of BCAA versus placebo on quality of life in cirrhotic patients with muscle cramps Participants with cirrhosis who have experienced muscle cramps at least once per week will be randomized to receive either a placebo or 12.45 grams of BCAA orally per day for 12 weeks.
详细描述
Cirrhosis is a late-stage of fibrosis of the liver caused by many forms of liver disease. Muscle cramps are visible or palpable involuntary contraction part of the muscle. The prevalence of cramps in cirrhosis varied range from 31-78%. The pathophysiology of cramps in cirrhosis was explained by multiple mechanisms such as energy metabolism, nerve function, and plasma volume. Cramps significantly diminished the quality of life in cirrhotic patients.
Many drugs, vitamins, and minerals were studied for treating cramps in cirrhosis in previous studies but no clinical improvement, good randomized control studies, or side effects.
Branched-chain amino acids (BCAA) had been developed to correct this amino acid imbalance and helped to decrease the frequency of cramps and improve the quality of life in cirrhotic patients from previous studies but there were no control groups and a small number of patients were included. The aim of this study was to evaluate the efficacy and safety of BCAA for controlling muscle cramps in cirrhotic patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
All participants will be randomized to receive BCAA or placebo. The BCAA and placebo were prepared by pharmacists who contained both 12.45 grams of BCAA and placebo in the same quantity, the same containing sachet, and labeled enveloped from No.1 to No.50. The sequence of labels was randomized by computer generator block of 4 randomizations with conceal allocation to investigators, participants, care providers, and outcomes assessor.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 18 years
- •Muscle cramp ≥ 1 time per week
- •Confirmed cirrhotic status (radiologic finding compatible with cirrhosis or liver stiffness measurement ≥ 12.5 kPa by transient elastography method or pathological confirm of cirrhosis)
排除标准
- •Allergy to BCAA
- •Overt hepatic encephalopathy
- •Hepatorenal syndrome
- •Severe renal insufficiency; eGFR < 30
- •Heart failure
- •Peripheral arterial disease
- •Active malignancies beyond hepatocellular carcinoma
- •Heavy alcohol drinking (> 21g/day for men and >14g/day for women)
- •Pregnancy or lactation
- •Current use of BCAA within 3 months
- •Recent adding or titrating diuretics within 4 weeks
- •On current medications for muscle cramp relief such as vitamin E, taurine, carnitine, narcotic pain medications, baclofen, methocarbamol, other muscle relaxers, NSAIDs, or other antispastic agents.
研究组 & 干预措施
BCAA group
12.45 grams of branched-chain amino acids orally per day before bedtime for 12 weeks.
干预措施: Branched-chain Amino Acid (Drug)
Placebo group
12.45 grams of placebo (Maltodextrin) orally per day before bedtime for 12 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Change of muscle cramp frequency
时间窗: 12 weeks
Change from baseline in muscle cramp frequency by patient's diary record
次要结局
- Change of muscle cramp duration(12 weeks)
- Serum aspartate aminotransferase(12 weeks)
- Change of muscle cramp severity(12 weeks)
- Quality of life in cirrhotic patients with muscle cramps(12 weeks)
- Muscle mass in cirrhotic patients with muscle cramps(12 weeks)
- Muscle strengthening in cirrhotic patients with muscle cramps(12 weeks)
- Serum albumin(12 weeks)
- Serum alanine aminotransferase(12 weeks)
研究者
Watcharasak Chotiyaputta
Associate professor, Faculty of Medicine, Siriraj Hospital
Mahidol University