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Effect of Zinc Suplementation on Serum Hemosystein Level in Hemodialysis Patients

This study has been completed.
Sponsor:
Information provided by:
Shiraz University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01101217
First received: April 8, 2010
Last updated: NA
Last verified: January 2009
History: No changes posted
  Purpose

The purpose of this study is to study the effect of zinc supplementation in end stage renal failure on hemocystein level.


Condition Intervention
End Stage Renal Failure
 Drug: Zinc Supplement
Drug: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Shiraz University of Medical Sciences:

Primary Outcome Measures:
  • decreased hemocystein level [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 100
Study Start Date: February 2009
Study Completion Date: September 2009
Arms Assigned Interventions
Placebo Comparator: placebo
placebo for 6 weeks
 Drug: placebo
placebo daily for 6 weeks
Active Comparator: zinc
zinc sulfate 220 mg per day orally for 6 weeks
 Drug: Zinc Supplement
in 50 patients zinc sulfate 220 mg per day orally for 6 weeks

Detailed Description:

hemocystein increased in end stage renal failure and zinc involved in hemocystein metabolism thus zinc supplementation may be effective on hemocystein level.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01101217

Locations
Iran, Islamic Republic of
Shiraz University Hemodialysis Center
Shiraz,, Fars, Iran, Islamic Republic of, 098
Sponsors and Collaborators
Shiraz University of Medical Sciences
  More Information

No publications provided

Responsible Party: Office of Vice Chancellor for research in Shiraz UMS, Shiraz University of Medical Science
ClinicalTrials.gov Identifier: NCT01101217     History of Changes
Other Study ID Numbers: 4542
Study First Received: April 8, 2010
Last Updated: April 8, 2010
Health Authority: Iran: Ministry of Health

Keywords provided by Shiraz University of Medical Sciences:
hemocystein zinc renal failure

Additional relevant MeSH terms:
Kidney Failure, Chronic
Renal Insufficiency
Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases
Zinc
 Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013