The Effect of High Oral Loading Dose of Cholecalciferol in Non-Alcoholic Fatty Liver Disease Patients. A Randomized Placebo Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Efficacy of cholecalciferol on glycaemic control parameters in non alcoholic fatty liver disease
研究概览
简要总结
Aim of work The aim of our study is to assess the effectiveness and safety of high oral loading dose of inactive vitamin D supplementation on the clinical parameters related to liver steatosis, glycaemic control, insulin resistance and metabolic profile in NAFLD patients
详细描述
Aim of work The aim of our study is to assess the effectiveness and safety of high oral loading dose of inactive vitamin D supplementation on the clinical parameters related to liver steatosis, glycaemic control, insulin resistance and metabolic profile in NAFLD patients
Patients and Methods The present study is prospective, simply (via computer generated sequence) randomized controlled double blinded study, will be conducted on NAFLD patients in the outpatient liver clinics of EL Sahel Teaching hospital, Cairo, Egypt, Inclusion criteria: To be included in the study, patients have to fulfil the following inclusion criteria: male or female patients >19 years of age; presence of fatty liver detected by upper abdominal ultrasound echography (US) and with diagnosis of T2D according to ADA 2019 criteria.
Exclusion Criteria: The main exclusion criteria from the study are as follows: Pregnancy and lactation, history of alcohol abuse (as defined by an average daily consumption of alcohol > 30 g/day in men and > 20 g/day women), cirrhosis, autoimmune hepatitis and other causes of liver disease (viral hepatitis, hemochromatosis, Wilson's disease), drug induced hepatitis, chronic enteropathies, Chronic kidney disease, hyper/hypoparathyroidism, known hypersensitivity to cholecalciferol.
Hundred eligible patients will be included into the study and randomized by simple randomization into either of the 2 groups:
Group 1: 50 patients receive the standard conventional therapy in addition to placebo for 4 months.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Study medications were given to the patients by an unblinded pharmacist to ensure the right treatment assignment, however this pharmacist was not included in the outcome assessment.
All patients were diagnosed with NAFLD depending on abdominal ultrasonography performed by a radiologist where the liver brightness and liver parenchyma with diffuse echogenicity in confirm the diagnosis.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients >18 years with fatty liver diagnosis by using upper abdominal ultrasound echography (US)
- •patients with T2D diagnosed according to ADA 2019 criteria and treated with metformin.
排除标准
- •Pregnant and/or lactating women,
- •excessive alcohol use (as defined by an average daily consumption of alcohol > 30 g/day in men and > 20 g/day women),
- •patients with other causes of chronic liver disease as viral hepatitis, drug induced hepatitis, autoimmune hepatitis, patients suffering of chronic kidney disease, hyper/hypoparathyroidism,
- •hypersensitivity to cholecalciferol,
- •hypercalcemia,
- •patients taking supplementation with vitamin D,
- •calcium and medications affecting calcium/vitamin D metabolism (as: anticonvulsants, glucocorticoids, antacids).
研究组 & 干预措施
Placebo
Group 1: patients receive the standard conventional therapy in addition to placebo for 4 months.
干预措施: Cholecalciferol (Drug)
Cholecalciferol
Group 2: patients receive the standard conventional therapy in addition to a single oral dose of cholecalciferol 300,000 IU followed by oral cholecalciferol 800 IU daily for 4 months.
干预措施: Cholecalciferol (Drug)
结局指标
主要结局
Efficacy of cholecalciferol on glycaemic control parameters in non alcoholic fatty liver disease
时间窗: at Baseline and at week 16
Decrease in glycated haemoglobin in NAFLD patients
次要结局
- Efficacy of cholecalciferol on the degree of steatosis in non alcoholic fatty liver disease(at Baseline and at week 16)
研究者
Radwa Maher Abd El Kader El Borolossy
Lecturer of clinical pharmacy
Ain Shams University