NCT02468518

Brief Summary

This study will be conducted to observe any change in aerobic bacterial pattern on the skin of arsenicosis patients before and after administration of vitamin E (200 IU) capsules.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Mar 2015

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 27, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 11, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

January 13, 2016

Status Verified

January 1, 2016

Enrollment Period

9 months

First QC Date

January 27, 2015

Last Update Submit

January 12, 2016

Conditions

Chronic Arsenic Poisoning

Outcome Measures

Primary Outcomes (1)

  • Identification of aerobic bacteria in five areas of the skin

    Change in Number of aerobic bacteria in five areas (palm, dorsum of the hand, front of the chest, axilla and nare) of the skin of patients in comparison to arsenic exposed controls and healthy volunteers after 12 weeks of supplementation with vitamin E

    0 weeks (baseline), 12 weeks (end)

Secondary Outcomes (1)

  • Clinical improvement in palmar arsenical keratosis following supplementation

    0 weeks (baseline), 12 weeks (end)

Study Arms (3)

Patients

EXPERIMENTAL

Vitamin E capsule 200 IU bd x 12 weeks

Drug: Vitamin E capsule

Arsenic exposed controls

ACTIVE COMPARATOR

Vitamin E capsule 200 IU bd x 12 weeks

Drug: Vitamin E capsule

Healthy volunteers

ACTIVE COMPARATOR

Vitamin E capsule 200 IU bd x 12 weeks

Drug: Vitamin E capsule

Interventions

Vitamin E capsuleDRUG

Capsules will be distributed to each participant free of cost

Also known as: E-Cap, Batch No. 461016
Arsenic exposed controlsHealthy volunteersPatients

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • History of drinking arsenic contaminated water (\>50 µg/L) for more than 6 months
  • Patients having moderate palmar keratosis
  • Patients those voluntarily agree to participate
  • Family members of the patient
  • History of drinking arsenic contaminated water (\>50 µg/L)
  • Those voluntarily agree to participate
  • No sign/symptoms of palmar keratosis
  • Drinking arsenic safe water (\<50 µg/L)
  • Those voluntarily agree to participate

You may not qualify if:

  • Pregnant and lactating mother
  • Any other chronic disease like tuberculosis, diabetes, asthma
  • Patients under treatment of arsenicosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Muradnagar Health Complex

Comilla, Bangladesh

Location

MeSH Terms

Interventions

Vitamin E

Intervention Hierarchy (Ancestors)

BenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Mir Misbahuddin

    Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. and Chairman

Study Record Dates

First Submitted

January 27, 2015

First Posted

June 11, 2015

Study Start

March 1, 2015

Primary Completion

December 1, 2015

Study Completion

January 1, 2016

Last Updated

January 13, 2016

Record last verified: 2016-01

Locations

BA(1)