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Vitamin E Level in Buccal Cells of Arsenicosis Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Prof. Mir Misbahuddin, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
ClinicalTrials.gov Identifier:
NCT01743066
First received: December 1, 2012
Last updated: December 4, 2012
Last verified: December 2012
History of Changes
  Purpose

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.


Condition Intervention
Chronic Arsenic Poisoning
 Dietary Supplement: Vitamin E

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Vitamin E Level in Buccal Cells of Arsenicosis Patients Following Vitamin E Supplementation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh:

Primary Outcome Measures:
  • Change in the amount of vitamin E in buccal cells [ Time Frame: 0 week (baseline), 20 weeks (end) ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Changes in the amount of cholesterol in buccal cells [ Time Frame: 0 week (baseline), 20 weeks (end) ] [ Designated as safety issue: No ]
    Changes in the amount of cholesterol 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.

  • Changes in the concentration of vitamin E in serum [ Time Frame: 0 week (baseline), 20 weeks (end) ] [ Designated as safety issue: No ]
    Changes in the concentration of vitamin E in serum of arsenicosis patients, arsenic exposed controls and healthy volunteers will be estimated both before and after supplementation with vitamin E for 20 weeks.

  • Changes in the concentration of cholesterol in serum [ Time Frame: 0 week (baseline), 20 weeks (end) ] [ Designated as safety issue: No ]
    Changes in the concentration of cholesterol in serum of arsenicosis patients, arsenic exposed controls and healthy volunteers will be estimated both before and after supplementation with vitamin E for 20 weeks.


Enrollment: 60
Study Start Date: October 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arsenicosis patients
Vitamin E (200 IU, caplet) daily orally for 20 weeks
 Dietary Supplement: Vitamin E
vitamin E (200 IU, caplet) daily orally for 20 weeks
Active Comparator: Arsenic exposed controls
vitamin E (200 IU, caplet) daily orally for 20 weeks
 Dietary Supplement: Vitamin E
vitamin E (200 IU, caplet) daily orally for 20 weeks
Active Comparator: Heathy volunteers
Vitamin E (200 IU, caplet) daily orally for 20 weeks
 Dietary Supplement: Vitamin E
vitamin E (200 IU, caplet) daily orally for 20 weeks

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • tuberculosis, eczema psoriasis, contact dermatitis
  • patients getting treatment of arsenicosis
  • subject who voluntarily do not agree to participate
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01743066

Locations
Bangladesh
Department of Pharmacology, Bangabandhu Sheikh Mujib Medical University
Dhaka, Bangladesh
Sponsors and Collaborators
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
  More Information

No publications provided

Responsible Party: Prof. Mir Misbahuddin, Prof. and Chairman, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
ClinicalTrials.gov Identifier: NCT01743066     History of Changes
Other Study ID Numbers: BSMMU-004-CT
Study First Received: December 1, 2012
Last Updated: December 4, 2012
Health Authority: Bangladesh: Ethical Review Committee

Keywords provided by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh:
Arsenic
Arsenicosis
Buccal cells
 Serum
Vitamin E
Cholesterol

Additional relevant MeSH terms:
Poisoning
Arsenic Poisoning
Substance-Related Disorders
Heavy Metal Poisoning, Nervous System
Neurotoxicity Syndromes
Nervous System Diseases
Vitamin E
Alpha-Tocopherol
Tocopherols
 Tocotrienols
Vitamins
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on May 23, 2013