Determination the effect of oral supplementation of zinc on glycemic status, lipid profile and body composition in non-diabetic hemodialysis patients
Design
In this randomized, double-blind, placebo-controlled trial, sixty-six non-diabetic hemodialysis patients were randomly divided into two groups.
Settings and conduct
The study was performed by attending the hemodialysis center of Ayatollah Taleghani Hospital and reviewing the patients' files and after providing sufficient explanations about the research design and obtaining written consent from patients with the inclusion and exclusion criteria.At first, people's general information was obtained. Subjects were coded into groups 1 and 2 by the Bias Coin method. Cans containing zinc gluconate and placebo were coded 2 and 1 by a researcher other than the researcher.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
At least 6 months have passed since the start of hemodialysis.
Patients undergo hemodialysis 3 times a week for 4-3 hours.
Non-diabetic hemodialysis patients
Exclusion criteria:
Patients are candidates for kidney transplant.
Patients with any symptoms of gastrointestinal disorders.
Patients taking penicillamine medication.
Patients taking glucocorticoid medication.
Patients taking estrogen medication.
Patients taking the antibiotic medication.
Women taking oral contraceptives.
Patients taking lipid lowering medications.
Patients with zinc malabsorption (Acroderma enteropathica).
Pregnant and lactating women.
Intervention groups
Intervention group: Daily consumption of a 30 mg tablet of zinc gluconate for 60 days,
manufactured by Dineh Iranian Pharmaceutical Company with standard therapy
Control group: Daily consumption of a placebo tablet containing corn starch, made by Dineh Iranian Pharmaceutical Company with standard treatment
Main outcome variables
Glycemic status; lipid profile; body composition
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191223045862N1
Registration date:2020-03-14, 1398/12/24
Registration timing:retrospective
Last update:2020-03-14, 1398/12/24
Update count:0
Registration date
2020-03-14, 1398/12/24
Registrant information
Name
Mohammad Mohajjel Halim
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3344 5257
Email address
mohammad.mohajjel.h@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-07, 1398/03/17
Expected recruitment end date
2019-07-08, 1398/04/17
Actual recruitment start date
2019-06-07, 1398/03/17
Actual recruitment end date
2019-07-08, 1398/04/17
Trial completion date
2019-09-15, 1398/06/24
Scientific title
The effect of oral supplementation of zinc on glycemic status, lipid profile and body composition in non-diabetic hemodialysis patients
Public title
The effect of oral supplementation of zinc on glycemic status, lipid profile and body composition in non-diabetic hemodialysis patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
At least 6 months have passed since the start of hemodialysis.
Patients undergo hemodialysis 3 times a week for 4-3 hours.
Non-diabetic hemodialysis patients
Exclusion criteria:
Patients are candidates for kidney transplant.
Patients with any symptoms of gastrointestinal disorders.
Patients taking penicillamine medication.
Patients taking glucocorticoid medication.
Patients taking estrogen medication.
Patients taking the antibiotic medication.
Women taking oral contraceptives.
Patients taking lipid lowering medications.
Patients with zinc malabsorption (Acroderma enteropathica).
Pregnant and lactating women.
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
66
Actual sample size reached:
61
Randomization (investigator's opinion)
Randomized
Randomization description
At the end of the sampling, individuals were contacted to begin the intervention.At the beginning of the intervention, the patients were assigned in groups 1 and 2 respectively. The first person in group 1, the second person in group 2 continued to 66.
Blinding (investigator's opinion)
Double blinded
Blinding description
Individuals were coded into groups 1 and 2. Also Cans containing Zinc gluconate and placebo tablets were coded 2 and 1 by someone other than the researcher and provided to the researcher in order to ensure that the researcher was not informed about the type of tablet consumed by each group.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Oroumia University of Medical Sciences
Street address
Oroumia University of medical science, Resalat Blvd.,Oroumia Town
City
Oroumia
Province
West Azarbaijan
Postal code
5714783734
Approval date
2018-10-03, 1397/07/11
Ethics committee reference number
IR.UMSU.REC.1397.248
Health conditions studied
1
Description of health condition studied
non-diabetic hemodialysis patients
ICD-10 code
N18.5
ICD-10 code description
Chronic kidney disease, stage 5
Primary outcomes
1
Description
Serum zinc level
Timepoint
At the beginning (day 0) and end of the intervention (day 60)
Method of measurement
Serum zinc level was measured using Dialab kit by BT-1500 autoanalyzer in micrograms / dL.
2
Description
Insulin resistance
Timepoint
At the beginning (day 0) and end of the intervention (day 60)
Method of measurement
Insulin resistance was calculated using the homeostasis model formula (HOMA-IR) as follows. HOMA-IR = [fasting insulin (μU/L) × fasting blood glucose (mg/dl)]/405
Secondary outcomes
1
Description
Serum albumin level
Timepoint
At the beginning (day 0) and end of the intervention (day 60)
Method of measurement
Serum albumin levels were measured using Dialab kit by BT-1500 autoanalyzer and in g / dl.
2
Description
Serum insulin level
Timepoint
At the beginning (day 0) and end of the intervention (day 60)
Method of measurement
Serum insulin level were measured using Dialab ELISA kit.
3
Description
Serum glucose level
Timepoint
At the beginning (day 0) and end of the intervention (day 60)
Method of measurement
Glucose level was measured using Pars Co kit and glucose oxidase enzymatic assay.
4
Description
Total cholesterol concentration
Timepoint
At the beginning (day 0) and end of the intervention (day 60)
Method of measurement
Total cholesterol concentration was measured using Dialab kit by enzymatic photometry.
5
Description
LDL-cholesterol concentration
Timepoint
At the beginning (day 0) and end of the intervention (day 60)
Method of measurement
Dialab kit was used to measure serum LDL-cholesterol concentration.
6
Description
HDL-cholesterol concentration
Timepoint
Dialab kit was used to measure serum HDL-cholesterol concentration.
Method of measurement
At the beginning (day 0) and end of the intervention (day 60)
7
Description
Serum triglyceride concentration
Timepoint
At the beginning (day 0) and end of the intervention (day 60)
Method of measurement
Serum triglyceride concentration was measured using Dialab kit and enzymatically.
8
Description
body composition
Timepoint
At the beginning (day 0) and end of the intervention (day 60)
Method of measurement
BIA model InBody 770 was used to determine body composition indices.
Intervention groups
1
Description
Intervention group: Daily consumption of a 30 mg tablet of zinc gluconate for 60 days, manufactured by Dineh Iranian Pharmaceutical Company with standard therapy
Category
Prevention
2
Description
Control group: Daily consumption of a placebo tablet containing corn starch, made by Dineh Iranian Pharmaceutical Company with standard treatment
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Taleghani Hospital
Full name of responsible person
Dr. Khadijeh Makhdoumi
Street address
Ayatollah Taleghani Hospital, Kashani St., Oroumia Town
City
Oroumia
Province
West Azarbaijan
Postal code
5715974677
Phone
+98 44 3348 7990
Email
hospital_taleghani@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Dr. Iraj Mohebbi
Street address
Oroumia University of medical science, Resalat Blvd., Oroumia Town
City
Oroumia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3193 7224
Fax
+98 44 3224 0642
Email
mohebbi_iraj@yahoo.co.uk
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Oroumia 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
Oroumia University of Medical Sciences
Full name of responsible person
Mohammad Mohajjel Halim
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Shohada dormitory, Naslow Road.,Oroumia Town
City
Oroumia
Province
West Azarbaijan
Postal code
5331678577
Phone
+98 41 3344 5257
Email
mohammad.mohajjel.h@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Mohammad Mohajjel Halim
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Shohada dormitory, Naslow Road., Oroumia Town
City
Oroumia
Province
West Azarbaijan
Postal code
5331678577
Phone
+98 41 3344 5257
Email
mohammad.mohajjel.h@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Mohammad Mohajjel Halim
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Shohada dormitory, Naslow Road., Oroumia Town
City
Oroumia
Province
West Azarbaijan
Postal code
5331678577
Phone
+98 41 3344 5257
Email
mohammad.mohajjel.h@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The data file is accessible after the results are published.
When the data will become available and for how long
Start of access period 6 months after the results are published
To whom data/document is available
The data will be available to researchers working in academic and scientific institutions.
Under which criteria data/document could be used
Before starting the analysis, the results should be coordinated with the researcher for guidance.
From where data/document is obtainable
Call the following number if needed.
09145268940
What processes are involved for a request to access data/document