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Improvement of oxidative stress injuries following the supplementation of zinc in chronic hemodialysis patients

Protocol summary

Summary
The purpose of the present investigation was to examine the effect of Zn supplementation on the improvement of uremic symptoms (through improvement of oxidative stress) in chronic HD patients. In a double blind, randomized, controlled crossover trial, 73 chronic HD patients without exclusion criteria were randomized into following groups. The patients received placebo or 100 mg elemental zinc daily for 2 months. The patients were crossed over after 2 months washout period and received alternative treatments. Serum levels of zinc, total antioxidant capacity, total glutathione, superoxide dismutase activity, malondialdehyde, lipid profile, antiphosholipid, and blood sugar at the baseline and 60th, 120th, 180th days were determined. Moreover, neurological and hematological factors, ejection fraction, blood pressure, taste acuity, smell, libido, and pruritus were measured at above-mentioned intervals.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138902033777N1
Registration date: 2003-10-10, 1382/07/18
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2003-10-10, 1382/07/18
Registrant information
Name
Mohammad Mazani
Name of organization / entity
Faculty of Medicine, Ardabil university of medical sciences,
Country
Iran (Islamic Republic of)
Phone
+98 45 1551 2788
Email address
m.mazani@www.arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz university of medical sciences
Expected recruitment start date
2003-10-10, 1382/07/18
Expected recruitment end date
2004-12-26, 1383/10/06
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Improvement of oxidative stress injuries following the supplementation of zinc in chronic hemodialysis patients
Public title
The effect of zinc supplementation in chronic hemodialysis patients
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria: Hemodialysis more than 6 month, Age more than 20 year, referring to Tabriz Sina Hospital for hemodialysis Exclusion criteria: presence of gastrointestinal disorders, smoking, kidney transplantation candidates, lactation, pregnancy, consumption of glucocorticoids, antibiotics, penicilamine, estrogens or contraceptives (in females), hospitalization due to other reasons than chronic renal failure
Age
From 20 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 73
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Crossover
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Drug Applied Research Center, Tabriz University of Medical Sciences
Street address
Drug Applied Research Center, Medical Research and Development Complex, Daneshgah St., Tabriz
City
Tabriz
Postal code
51656-65811
Approval date
2003-03-15, 1381/12/24
Ethics committee reference number
5/79/3295

Health conditions studied

1

Description of health condition studied
patients with hemodialsis
ICD-10 code
N00, N01,N
ICD-10 code description
Acute nephritic syndrome, Rapidly progressive nephritic syndrome, Chronic nephritic syndrome, Nephrotic syndrome, Unspecified nephritic syndrome, Glomerular disorders in diseases classified elsewhere, Acute renal failure, Chronic renal failure, Unspecifie

Primary outcomes

1

Description
serum level of zinc
Timepoint
Baseline and days 60, 120, and 180 after the intervention in each period
Method of measurement
as microgram per deciliter scale by atomic absorption spectrophotometry

2

Description
Serum total antioxidant capacity
Timepoint
Baseline and days 60, 120, and 180 after the intervention in each period
Method of measurement
as mM scale by spectrophotometry

3

Description
red blood cell superoxide dismutase activity
Timepoint
Baseline and days 60, 120, and 180 after the intervention in each period
Method of measurement
as unit per gram of hemoglobin scale by spectrophotometry

4

Description
serum total glutathione
Timepoint
Baseline and days 60, 120, and 180 after the intervention in each period
Method of measurement
as mM scale by spectrophotometry

5

Description
malondialdehyde (MDA)
Timepoint
Baseline and days 60, 120, and 180 after the intervention in each period
Method of measurement
as nmol/ml scale by spectrophotometry

6

Description
fasting serum glucose
Timepoint
Baseline and days 60, 120, and 180 after the intervention in each period
Method of measurement
as mg/dl scale by spectrophotometry

7

Description
Serum total cholesterol
Timepoint
4 time at 2 month interval at the 0th, 60th, 120th and 180th days of study (before and after intervention period, before and after placebo period)
Method of measurement
as mg/dl scale by spectrophotometry

8

Description
serum triglyceride
Timepoint
Baseline and days 60, 120, and 180 after the intervention in each period
Method of measurement
as mg/dl scale by spectrophotometry

9

Description
HDL cholesterol
Timepoint
Baseline and days 60, 120, and 180 after the intervention in each period
Method of measurement
as mg/dl scale by spectrophotometry

10

Description
LDL cholesterol
Timepoint
Baseline and days 60, 120, and 180 after the intervention in each period
Method of measurement
as mg/dl scale by spectrophotometry

11

Description
serum total lipid
Timepoint
Baseline and days 60, 120, and 180 after the intervention in each period
Method of measurement
as mg/dl scale by spectrophotometry

12

Description
Central and peripheral nerves evaluation
Timepoint
Baseline and days 60, 120, and 180 after the intervention in each period
Method of measurement
as m/s, ms and µv scales by electrodiagnostic test

13

Description
serum antiphospholipid
Timepoint
Baseline and days 60, 120, and 180 after the intervention in each period
Method of measurement
as u/ml by ELIZA

14

Description
cardiac ejection fraction
Timepoint
Baseline and days 60, 120, and 180 after the intervention in each period
Method of measurement
as % by echocardiography

15

Description
blood pressure
Timepoint
Baseline and days 60, 120, and 180 after the intervention in each period
Method of measurement
as mmHg by mercury manometer

Secondary outcomes

1

Description
taste perception evaluation
Timepoint
Baseline and days 60, 120, and 180 after the intervention in each period
Method of measurement
scale of taste acuity by taste tesing (Fernstrom A et al. Nephrol 1996 :45(3):169-74)

2

Description
pruritus evaluation
Timepoint
Baseline and days 60, 120, and 180 after the intervention in each period
Method of measurement
as pruritic score by pruritus questionnaire

3

Description
cell blood count (CBC) and diffraction
Timepoint
Baseline and days 60, 120, and 180 after the intervention in each period
Method of measurement
as number per microliter and % scale by Cell counter

4

Description
smell testing
Timepoint
Baseline and days 60, 120, and 180 after the intervention in each period
Method of measurement
smell test by pipe tobacco

5

Description
libido
Timepoint
Baseline and days 60, 120, and 180 after the intervention in each period
Method of measurement
by questionnaire

Intervention groups

1

Description
cornstarch, 2 capsules per day for 2 months
Category
Placebo

2

Description
zinc sulfates pentahydrate, two 220 mg capsules per day for 2 months
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
kyghobad Niyazmand
Street address
Sina Hospital, Azadi street, Tabriz
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Drug Applied Research Center-Tabriz University of Medical Sciences
Full name of responsible person
Dr Mesgari
Street address
Drug Applied Research Center - Medical Research and Development Complex Daneshgah St. Tabriz
City
Tabriz
Grant name
31303000
Grant code / Reference number
124203
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Drug Applied Research Center-Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Ardabil University of Medical sciences - faculty of medicine
Full name of responsible person
Mohammad Mazani
Position
PhD of clinical biochemistry, Assistant Professor
Other areas of specialty/work
Street address
Faculty of medicine, Ardabil University of Medical sciences,
City
Ardabil
Postal code
56198-53142
Phone
+98 45 1551 2788
Fax
+98 45 1551 0057
Email
m.mazani@www.arums.ac.ir
Web page address
www.arums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Faculty of medicine, Ardabil University of Medical sciences
Full name of responsible person
Mohammad Mazani
Position
PhD of clinical biochemistry, Assistant Professor
Other areas of specialty/work
Street address
Faculty of medicine, Ardabil University of Medical sciences, Ardabil
City
Ardabil
Postal code
56198-53142
Phone
+98 45 1551 2788
Fax
+98 45 1551 0057
Email
m.mazani@www.arums.ac.ir
Web page address
www.arums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Faculty of medicine, Ardabil University of Medical sciences
Full name of responsible person
Mohammad Mazani
Position
PhD of clinical biochemistry, Assistant Professor
Other areas of specialty/work
Street address
Faculty of medicine, Ardabil University of Medical sciences, Ardabil
City
Ardabil
Postal code
56198-53142
Phone
+98 45 1551 2788
Fax
+98 45 1551 0057
Email
m.mazani@www.arums.ac.ir
Web page address
www.arums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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