Effect of Zinc Suplementation on Serum Hemosystein Level... | NCT01101217

Studies
Effect of Zinc Suplementation on Serum Hemosystein Level in Hemodialysis Patients

NCT01101217

Sponsor

Shiraz University of Medical Sciences

Status

Completed

Last Update Posted

Apr 9, 2010Estimated

Enrollment

100Actual

Phase

Not Applicable

Conditions

End Stage Renal Failure

Interventions

Zinc Supplement
placebo

Countries

Iran

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2009

Primary Completion Date

Not provided

Completion Date

Sep 2009Actual

First Submitted Date

Apr 8, 2010

First Submission Date that Met QC Criteria

Apr 8, 2010

First Posted Date

Apr 9, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 8, 2010

Last Update Posted Date

Apr 9, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
placebo	Placebo Comparator	placebo for 6 weeks	Drug: placebo
zinc	Active Comparator	zinc sulfate 220 mg per day orally for 6 weeks	Drug: Zinc Supplement

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Zinc Supplement	Drug	in 50 patients zinc sulfate 220 mg per day orally for 6 weeks	zinc

Measure	Description	Time Frame
decreased hemocystein level		6 months

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shiraz University Hemodialysis Center		Shiraz	Fars	098	Iran

Condition Browse Module

MeSH Terms

ID	Term
D051436	Renal Insufficiency, Chronic

Ancestor Terms

ID	Term
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided