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Effect of Zinc Suplementation on Serum Hemosystein Level in Hemodialysis Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01101217
Recruitment Status : Completed
First Posted : April 9, 2010
Last Update Posted : April 9, 2010
Sponsor:
Information provided by:

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.

Condition or disease Intervention/treatment
End Stage Renal Failure Drug: Zinc Supplement Drug: placebo

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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : February 2009
Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Failure
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. decreased hemocystein level [ Time Frame: 6 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: April 9, 2010    Key Record Dates
Last Update Posted: April 9, 2010
Last Verified: January 2009

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

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