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Effect of Zinc Suplementation on Serum Hemosystein Level in Hemodialysis Patients

Primary Purpose

End Stage Renal Failure

Status
Completed
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Zinc Supplement
placebo
Sponsored by
Shiraz University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for End Stage Renal Failure focused on measuring hemocystein zinc renal failure

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • hemodialysis for 3 months
  • older than 18 years old
  • serum level of zinc less than 72.6 microgram/ l in men and less than 70 microgram/ l in female

Exclusion Criteria:

  • acute renal failre
  • malabsorption
  • history of steroid or cytotoxic consumption

Sites / Locations

  • Shiraz University Hemodialysis Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

placebo

zinc

Arm Description

placebo for 6 weeks

zinc sulfate 220 mg per day orally for 6 weeks

Outcomes

Primary Outcome Measures

decreased hemocystein level

Secondary Outcome Measures

Full Information

First Posted
April 8, 2010
Last Updated
April 8, 2010
Sponsor
Shiraz University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01101217
Brief Title
Effect of Zinc Suplementation on Serum Hemosystein Level in Hemodialysis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2009
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Shiraz University of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to study the effect of zinc supplementation in end stage renal failure on hemocystein level.
Detailed Description
hemocystein increased in end stage renal failure and zinc involved in hemocystein metabolism thus zinc supplementation may be effective on hemocystein level.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Failure
Keywords
hemocystein zinc renal failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
placebo for 6 weeks
Arm Title
zinc
Arm Type
Active Comparator
Arm Description
zinc sulfate 220 mg per day orally for 6 weeks
Intervention Type
Drug
Intervention Name(s)
Zinc Supplement
Intervention Description
in 50 patients zinc sulfate 220 mg per day orally for 6 weeks
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo daily for 6 weeks
Primary Outcome Measure Information:
Title
decreased hemocystein level
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: hemodialysis for 3 months older than 18 years old serum level of zinc less than 72.6 microgram/ l in men and less than 70 microgram/ l in female Exclusion Criteria: acute renal failre malabsorption history of steroid or cytotoxic consumption
Facility Information:
Facility Name
Shiraz University Hemodialysis Center
City
Shiraz,
State/Province
Fars
ZIP/Postal Code
098
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Learn more about this trial

Effect of Zinc Suplementation on Serum Hemosystein Level in Hemodialysis Patients

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