The Effect of High Oral Loading Dose of Cholecalciferol in Non-Alcoholic Fatty Liver Disease Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Fasting blood glucose (FBG mg/dl)
研究概览
简要总结
Non-alcoholic fatty liver disease (NAFLD) is a metabolic disorder with high prevalence in patients suffering from chronic liver diseases [1]. NAFLD is characterized by the accumulation of > 5% of fat deposits in hepatocytes (hepatic steatosis) with no known other reasons for steatosis as excessive alcohol intake.The global prevalence of NAFLD differs depending on the population reaching 13% in Africa, 32% in the Middle East, and 30 % in the United States
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
- Double (Participant, Care Provider)
盲法说明
double-blinded
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Either male or female adult patients (>19 years) with fatty liver diagnosis by using upper abdominal ultrasound echography (US) and with type II diabetes diagnosed according to American Diabetes Association (ADA) 2019 criteria and treated with metformin
排除标准
- •pregnant and/or lactating women, excessive alcohol use (defined as an average alcohol intake of> 30 g per day in men and > 20 g per day in women),
- •Other etiology of chronic liver diseases such as viral hepatitis, drug-induced hepatitis, autoimmune hepatitis, patients suffering from chronic kidney disease, and hyper/hypoparathyroidism.
- •Hypersensitivity to cholecalciferol, hypercalcemia, patients taking supplementation with vitamin D, and calcium.
- •Medications affecting calcium/vitamin D metabolism (as anticonvulsants, glucocorticoids, and antacids).
研究组 & 干预措施
Control Group
50 patients will receive the standard conventional therapy in addition to a placebo for 4 months.
干预措施: Placebo (Drug)
Vit D Group
50 patients were given the standard conventional therapy plus cholecalciferol. Cholecalciferol was given as a high oral loading dose of 300,000 IU followed by a daily oral dose of 800 IU for 4 months.
干预措施: Cholecalciferol (Drug)
结局指标
主要结局
Fasting blood glucose (FBG mg/dl)
时间窗: 4 months
Glycated hemoglobin (HbA1C%)
时间窗: 4 months
Fasting insulin (mU/L).
时间窗: 4 months
Aspartate transaminase (AST U/L)
时间窗: 4 months
Albumin (g/dl)
时间窗: 4 months
Gamma-glutamyl transferase (GGT U/L)
时间窗: 4 months
Alkaline phosphatase (ALP U/L)
时间窗: 4 months
Lipid profile: Low-density lipoprotein (LDL-C mg/dl), High-density lipoprotein (HDL-C mg/dl)
时间窗: 4 months
Lipid profile: Triglycerides (TG mg/dl)
时间窗: 4 months
Lipid profile: Total cholesterol (TC mg/dl)
时间窗: 4 months
Alanine transaminase (ALT U/L)
时间窗: 4 months
次要结局
未报告次要终点
研究者
Mostafa Bahaa
Teaching Assistant
Tanta University