NCT01101217

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2009

Shorter than P25 for not_applicable

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

Study Start

First participant enrolled

February 1, 2009

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 8, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 9, 2010

Completed
Last Updated

April 9, 2010

Status Verified

January 1, 2009

First QC Date

April 8, 2010

Last Update Submit

April 8, 2010

Conditions

End Stage Renal Failure

Keywords

hemocystein zinc renal failure

Outcome Measures

Primary Outcomes (1)

  • decreased hemocystein level

    6 months

Study Arms (2)

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

Zinc SupplementDRUG

in 50 patients zinc sulfate 220 mg per day orally for 6 weeks

zinc
placeboDRUG

placebo daily for 6 weeks

placebo

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shiraz University Hemodialysis Center

Shiraz, Fars, 098, Iran

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 8, 2010

First Posted

April 9, 2010

Study Start

February 1, 2009

Study Completion

September 1, 2009

Last Updated

April 9, 2010

Record last verified: 2009-01

Locations

IR(1)