Efficacy of vitamin E in combination with standard medical treatment vs standard medical treatment alone on myosteatosis in patients with cirrhosis a randomised controlled trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- PGIMER
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- To assess the effect of Vitamin E on Myosteatosis in patients with cirrhosis as measured by CT.
研究概览
简要总结
Cirrhosis is a progressive liver disease marked by fibrosis and structural liver damage, leading to significant morbidity and mortality. One of its under-recognized but clinically significant complications is myosteatosis, characterized by pathological fat infiltration within skeletal muscle. Myosteatosis is closely linked with sarcopenia, frailty, poor physical performance, and increased mortality in cirrhotic patients. Despite standard medical treatment (SMT), muscle loss and fat infiltration persist, highlighting the need for adjunctive therapies.
Vitamin E, a potent fat-soluble antioxidant, may offer therapeutic benefit in myosteatosis by mitigating oxidative stress and inflammation—key drivers in muscle deterioration in cirrhosis. Preliminary studies have indicated potential improvements in muscle function and hepatic parameters with vitamin E supplementation. However, high-quality clinical evidence in this population is lacking.
This prospective, open-label, randomized controlled trial at PGIMER, Chandigarh, aims to evaluate the efficacy of Vitamin E (400 mg BID for 6 months) in combination with SMT versus SMT alone in 100 cirrhotic patients with radiologically confirmed myosteatosis. Key outcomes include changes in muscle radiodensity (HU) at L3 vertebra, skeletal muscle index (SMI), inflammatory markers (CRP, IL-6), ammonia levels, frailty index, quality of life, and prognostic liver scores (CTP, MELD). Radiological assessments via CT, handgrip strength, and bioelectrical impedance analysis (BIA) will be utilized for objective measurements.
The hypothesis is that vitamin E supplementation will lead to improved muscle composition, reduced systemic inflammation, better clinical outcomes, and improved survival. The study also seeks to address the lack of standardized treatment strategies for myosteatosis in cirrhosis and may potentially redefine management protocols.
By generating evidence on vitamin E’s efficacy, this trial could contribute significantly to improving quality of life and reducing complications in cirrhotic patients, thereby filling a critical gap in hepatology research.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Age between 18-75 years
- •Cirrhosis of any etiology with CTP score less than and equal to 10
- •Evidence of myosteatosis on CT.
排除标准
- •CTP score greater than 10
- •Acute on chronic liver failure (ACLF)
- •Active malignancy, hepatocellular carcinoma, or end-stage renal disease
- •Prior study enrollment or concurrent enrollment in conflicting studies
- •Non-consenting patients
- •Recent participation in other clinical trials (within 3 months)
- •Active infection
- •Acute organic brain disease within the last 6 months
- •Severe hemodynamic instability, significant heart disease, bradycardia, or tachycardia
- •Severe cognitive impairment, overt hepatic encephalopathy, or physical disability
- •Pregnancy or breastfeeding
- •Post-liver transplant patients
- •Previous exposure to Vitamin E within 12 weeks
- •Known hypersensitivity to Vitamin E.
结局指标
主要结局
To assess the effect of Vitamin E on Myosteatosis in patients with cirrhosis as measured by CT.
时间窗: To assess the effect of Vitamin E on Myosteatosis in patients with cirrhosis as measured by CT at 6 months
次要结局
- 1. To study the effect on sarcopenia (skeletal muscle at L3 vertebral level on CT), “Subcutaneous Adipose Tissue (SAT)”, “Visceral Adipose Tissue (VAT)” and “Total Body Fat (TBF)” at 6 months.(2. Effect of Vitamin E on Frailty.)
研究者
SUNIL TANEJA
Post Graduate Institute Of Medical Research And Education