Evaluation of Efficacy and Safety of Nicotinamide in Non-Alcoholic Fatty Liver Disease Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Steatosis using Fibroscan with CAP
研究概览
简要总结
The purpose of the study is to evaluate the efficacy and safety of Niacinamide supplementation on clinical outcome of fatty liver patients having type II DM through measurement of the following before and after Niacinamide administration: Liver enzymes, Lipid profie, HOMA-IR, Oxidative stress markers and endothelial dysfunction marker. Fibroscan with CAP will be done at baseline and at the end of the trial. Also, Evaluation of quality of life of patients before and after Niacinamide administration using Chronic Liver Disease questionnaire.
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
- None
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
- 是
入选标准
- •Male or female outpatients age 18 to 70 years old.
- •The diagnosis of NAFLD will be established according to the appearance of fatty liver on US or elevated liver enzymes (>1.5 times normal level).
排除标准
- •History of alcohol abuse (as defined by an average daily consumption of alcohol > 30 g/day in men and > 20 g/day in women).
- •Cirrhotic patients.
- •Fibroscan result > 12Kpa or as
- •predicted from FIB 4 score > 3.25
- •FIB-4 = age (yr) * AST (IU/L)/platelet count (109/L) * ALT1/2 (IU/L)
- •Hyper / hypoparathyroidism.
- •Viral hepatitis.
- •Biliary disease.
- •Autoimmune hepatitis
- •Other causes of liver disease (hemochromatosis, Wilson's disease).
- •Participants who took antibiotics, probiotic supplements and/or hepatotoxic medicines (NSAIDs, Amiodarone and methotrexate) within 6 months before the start of the study and during the study.
- •Ascetic patients and congestive heart failure patients will be excluded due to unreliability of Fibroscan results in them.
- •Pregnancy and lactation.
研究组 & 干预措施
Niacinamide group
Niacinamide oral tablets as Nature's Life 1000 mg tablets once daily for 3 months diabetes management including metformin or Sulphonylurea
干预措施: Niacinamide Oral Tablet (Dietary Supplement)
Niacinamide group
Niacinamide oral tablets as Nature's Life 1000 mg tablets once daily for 3 months diabetes management including metformin or Sulphonylurea
干预措施: Antidiabetic (Drug)
Control group
diabetes management including metformin or Sulphonylurea
干预措施: Antidiabetic (Drug)
结局指标
主要结局
Steatosis using Fibroscan with CAP
时间窗: 3 months
using Fibroscan with CAP
Adiponectin mesurement
时间窗: 3 months
Endothelial dysfunction
次要结局
- Malondialdehyde(3 monthes)
- ALT, AST(3 months)
- LDL, cholesterol(3 months)
- HOMA-IR(3 months)
研究者
Rasha Roshdy Ibrahim El-kady
Teaching assisstant at department clinical pharmacy
Ain Shams University