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临床试验/NCT01743066
NCT01743066已完成不适用

Vitamin E Level in Buccal Cells of Arsenicosis Patients Following Vitamin E Supplementation

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2010年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Change in the amount of vitamin E in buccal cells

研究概览

简要总结

To understand the pathogenesis of chronic arsenic toxicity, the investigators need to know the levels of vitamin E in patients chronically exposed to high concentration of arsenic and if changes are found, what happens when supplemented with vitamin E. The buccal cells and serum of patients will be collected for the estimation of vitamin E both before and after supplementation with vitamin E. Similar samples will be collected from similar number of arsenic exposed controls and healthy volunteers for comparison.

详细描述

Chronic consumption of arsenic through water (drinking and cooking) and food leads to accumulation of arsenic within the cell. We usually give emphasis on the skin manifestations (melanosis and keratosis) of arsenicosis that is diagnosed first. Other manifestations remain un-diagnosed or diagnosed later. The severe form is the development of cancer in different organs mainly skin, lungs and urinary bladder. To understand the pathophysiology of the development of clinical manifestations appearing in the skin first, we need to understand interior of cells other than skin. One of the dietary supplements, vitamin E is found to be effective in improving the clinical signs/symptoms of melanosis and keratosis. Buccal cells are also exposed to arsenic and easy to collect. To understand the pathogenesis, we need to know the levels of vitamin E in patients of arsenicosis and if changes, what happens when supplemented with vitamin E. The buccal cells and serum of 20 patients will be collected for the estimation of vitamin E both before and after supplementation with vitamin E (200 IU, caplet) daily orally for 20 weeks. Similar samples will be collected from 20 arsenic exposed controls and 20 healthy volunteers for comparison.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
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

入选标准

  • For arsenicosis
  • who drank arsenic contaminated water (>50 µg/L) for more than 6 months
  • having physical signs of moderate degree of melanosis and keratosis
  • For arsenic exposed control
  • relative or family member of the patient
  • showing no physical signs of melanosis and keratosis
  • share same tube well water for drinking purpose for more than 6 months
  • For healthy volunteers
  • who drank arsenic safe water (<50 µg/L)
  • live in the same Upazilla
  • have no cutaneous manifestation
  • who voluntarily agree to participate

排除标准

  • tuberculosis, eczema psoriasis, contact dermatitis
  • patients getting treatment of arsenicosis
  • subject who voluntarily do not agree to participate

结局指标

主要结局

Change in the amount of vitamin E in buccal cells

时间窗: 0 week (baseline), 20 weeks (end)

Changes in the amount of vitamin E in buccal cells of arsenicosis patients, arsenic exposed controls and healthy volunteers will be estimated both before and after supplementation with vitamin E for 20 weeks.

次要结局

  • Changes in the amount of cholesterol in buccal cells(0 week (baseline), 20 weeks (end))
  • Changes in the concentration of vitamin E in serum(0 week (baseline), 20 weeks (end))
  • Changes in the concentration of cholesterol in serum(0 week (baseline), 20 weeks (end))

研究者

发起方
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof. Mir Misbahuddin

Prof. and Chairman

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

研究点 (1)

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