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Evaluation of the effect of zinc supplement on body composition, hand grip strength, appetite and skin lesions in hemodialysis patients

Protocol summary

Study aim
Determination and comparison of appetite, skin disorders and body composition in the intervention and control groups before and after the intervention
Design
Clinical trial with control group, with parallel group, double-blind, randomized,Single phase on 80 patients . For randomization we use SPSS software version 25
Settings and conduct
80 hemodialysis patients referred to the dialysis center of Isfahan Khorshid Hospital will be divided into two groups of 40 people. The studied variables will be measured in all individuals, then for twelve weeks one group with zinc gluconate supplement and the other group with placebo in two They will be complementary and after the complementary period, the variables will be measured and checked again.
Participants/Inclusion and exclusion criteria
Patients who have been on dialysis for at least 3 months, Dialyze at least twice a week, Do not smoke No pregnancy and lactation Lack of nutrition through antral and parenteral No other diseases such as cancer,inflammatory diseases and advanced liver disease Do not take calcium and vitamin D supplements Do not take drugs that affect dependent variables
Intervention groups
Eligible written consent will be obtained from eligible individuals who wish to participate in the study. Individuals are also asked to complete a questionnaire on demographic information, medical history, and medications. Then, using SPSS software and based on the code assigned to each person, by stratified randomization by BMI (between 25-25 and 25-30) and gender are divided into two groups of intervention and control.
Main outcome variables
Zinc gluconate supplementation, appetite changes, skin lesions, body composition, serum zinc level

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20130903014551N7
Registration date: 2020-10-05, 1399/07/14
Registration timing: prospective

Last update: 2020-10-05, 1399/07/14
Update count: 0
Registration date
2020-10-05, 1399/07/14
Registrant information
Name
Mohammad Hossein Rouhani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 3183
Email address
s_m_rouhani2003@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-22, 1399/08/01
Expected recruitment end date
2021-01-19, 1399/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of zinc supplement on body composition, hand grip strength, appetite and skin lesions in hemodialysis patients
Public title
The effect of zinc supplementation in hemodialysis patients
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who have been on dialysis for at least 3 months Dialysis at least twice a week Do not smoke No pregnancy and lactation Other diseases such as cancer, inflammatory diseases and advanced liver disease Do not take calcium and vitamin D supplements Do not take drugs that affect dependent variables
Exclusion criteria:
Performing a kidney transplant by a person Enteral and Parenteral Feeding Individual non-compliance with the study protocol Show complications side effects by the person to supplement Change the type of dialysis
Age
From 18 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done through block randomization method (permuted blocked randomization). depending on the sample size , each block includes 4 characters and will be used AABB combination. In the following, all possible modes from the combination will be listed and a code will be allocated to each patient. This will be done using a random number table.
Blinding (investigator's opinion)
Double blinded
Blinding description
For double blinding of this study, at the beginning, cans contained zinc supplement and placebo were coded as A and B by person other than researcher to ensure researcher and participants were not informed about types of supplement received by participants
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Street address
Esfahan University of Medical Sciences, Hezar Jerib street, Esfahan, Iran
City
esfahan
Province
Isfehan
Postal code
8174673461
Approval date
2020-10-03, 1399/07/12
Ethics committee reference number
IR.MUI.RESEARCH.REC.1399.405

Health conditions studied

1

Description of health condition studied
Hemodialysis
ICD-10 code
Z99.2
ICD-10 code description
Dependence on renal dialysis

Primary outcomes

1

Description
appetite
Timepoint
Before and after intervention
Method of measurement
Based on a questionnaire approved by VAS method

2

Description
Skin lesions
Timepoint
Before and after intervention
Method of measurement
Through observation and questionnaire completed by the individual

3

Description
Body composition
Timepoint
Before and after intervention
Method of measurement
By body analysis device and BIA method

4

Description
The power of the grip of the hand
Timepoint
Before and after intervention
Method of measurement
By handgrip device

Secondary outcomes

1

Description
Serum zinc level
Timepoint
Before and after the intervention
Method of measurement
By measuring the amount of zinc in a person's blood

Intervention groups

1

Description
Intervention group: People in this group receive Dine Company Zinc Gluconate 30 mg supplement every day for 12 weeks.
Category
Treatment - Other

2

Description
Control group: People in this group receive a placebo containing lactose and made by the company every day for 12 weeks
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Khorshid Hospital
Full name of responsible person
Dr. Shahrzad Shahidi
Street address
Ostandari Street - Next to Shahid Dastgheib Boulevard - Khorshid Hospital
City
Isfahan
Province
Isfehan
Postal code
8145833117
Phone
+98 31 3222 2127
Fax
+98 31 3222 2255
Email
nour@mui.ac.ir
Web page address
http://nour.mui.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Shaghayegh Haghjoo Javanmard
Street address
Deputy of Research & Technology of Esfahan University of Medical Sciences, Hezar Jarib Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8138
Fax
+98 31 3668 7898
Email
sh_haghjoo@med.mui.ac.ir
Web page address
http://research.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohammad Tavassoli
Position
Executor of plan
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Esfahan University of Medical Sciences, Hezar Jarib Street, Esfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3183
Email
mtk137551@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Seyed Mohammad Hossein Rouhani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Isfahan University of Medical Sciences, Hezar Jarib Street, Azadi Square
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3183
Email
sm_rouhani@nutr.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohammad Tavassoli
Position
Executor of plan
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Isfahan University of Medical Sciences, Hezar Jarib Street, Azadi Square
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3183
Email
mtk137551@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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