Comparative Effect of Different Concentrations of Vitamin E Supplementation in Management of Calcium Oxalate Crystals in Nephrolithiatic Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Urine Analysis
研究概览
简要总结
Nephrolithiasis is a condition characterized by the formation of crystalline stones in the urinary system. The most common component of these stones is calcium oxalate. The current study was proposed to explore the effect of different concentration of vitamin E supplementation on Calcium oxalate crystal among nephrolithiatic patients.
详细描述
A randomized controlled trial (pre-post treatment) was conducted on 48 participants who met the inclusion criteria. The participants were selected from the OPD of Hussain Memorial Hospital in Lahore. They were divided into three groups, with each group consisting of 16 participants. The control group (T0) did not receive any treatment, while the treatment groups received different doses of Vitamin E supplementation. The first treatment group (T1) received 200mg of Vitamin E supplementation, and the second treatment group (T2) received 400mg of Vitamin E supplementation, both for a duration of 8 weeks. Data was collected at baseline and after the 8th week of the study, including blood samples for renal function tests (RFT), ultrasounds, and 24-hour urine samples for calcium and oxalate analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Both male and female.
- •Participants between the age of 20-50 years old.
- •Presence of calcium oxalate crystals in urine and kidneys
- •The size of the stones will range from 2 to 5 mm.
排除标准
- •People having stones of Uric acid, struvite, Cystine.
- •People having any other medical condition (End stage renal disease, Chronic Kidney disease, Kidney failure, and dialysis) .
- •Subjects were excluded if they were taking any medications, which might affect vitamin E metabolism (such as Wrafrin, dalteparin sodium, enoxaparin sodium).
- •Pregnant and lactating females.
- •People having known allergies to Vitamin E supplementation (rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing).
- •Participants enrolled in other studies or taking other nutraceutical preparations.
结局指标
主要结局
Urine Analysis
时间窗: 8 weeks
The laboratory reading of urine analysis involves the identification and microscopic examination of urine to assess the characteristics and concentration of calcium and oxalate crystals present.
Renal function test
时间窗: 8 weeks
This involved measuring the levels of BUN (blood urea nitrogen) and creatinine in the blood.
次要结局
未报告次要终点
研究者
Maria Aslam
Clinical Head
University of Lahore