The effect of zinc supplementation on appetite status, biochemical parameters and food intake in patients with chronic renal failure under hemodialysis
Determining the effect of zinc supplementation on appetite status and biochemical parameters and food intake in patients with chronic renal failure under hemodialysis
Design
this randomized single-blind clinical trial that will be performed in patients with renal failure under hemodialysis. And will last for 8 weeks.
Sampling: Conventional sampling method is used. The sample size is 34 people.
Settings and conduct
Due to the ineffectiveness of the control and intervention group, we will use dialysis unit in Golestan and Razi hospitals of Ahwaz. Patients in a hospital as an intervention group and other hospital patients will be considered as a control group.
Participants/Inclusion and exclusion criteria
inclusion criteria:
Age between 20-80 years
At least 6 months of dialysis
2-3 times the dialysis per week
Not having trouble eating or digestion
Non-use of any multivitamin and minerals (except venofer, aprex)
Lack of hospitalization or hospitalization during the
exclusion criteria:
Unwillingness to cooperate
Intervention groups
The intervention group will receive zinc sulfate supplements to improve weigh gain and appetite status and the control group will also receive a placebo.
The effect of zinc supplementation on appetite status, biochemical parameters and food intake in patients with chronic renal failure under hemodialysis
Public title
Effect of zinc supplementation in patients undergoing hemodialysis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 20-80 years
At least 6 months of hemodialysis
2-3 with hemodialysis per week
No problems in eating and indigestion
Non-use of any multivitamin and minerals
Lack of hospitalization or hospitalization during the study
Lack of infection, liver failure, cancer, thyroid problem when entering or during study
Exclusion criteria:
Unwilling to participate in the study
Age
From 20 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
38
Actual sample size reached:
38
Randomization (investigator's opinion)
Randomized
Randomization description
Written on a sheet of paper from 1 to 34 and randomly divided into 2 parts.
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants and some health care personnel
Placebo
Used
Assignment
Other
Other design features
This study has two groups of control and intervention. The intervention group received zinc supplements and the control group received a placebo.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
School Of Nutrition And Food Sciences, Razi Blvd, Shiraz
City
shiraz
Province
Fars
Postal code
7153675541
Approval date
2016-11-05, 1395/08/15
Ethics committee reference number
IR.SUMS.REC.1395.143
Health conditions studied
1
Description of health condition studied
Patients with chronic renal failure under hemodialysis
ICD-10 code
N18
ICD-10 code description
Chronic kidney disease (CKD)
Primary outcomes
1
Description
Dry weight
Timepoint
At the beginning of the study and 60 days after taking zinc supplement or placebo
Method of measurement
seca scales
2
Description
Blood urea nitrogen
Timepoint
At the beginning of the study and 60 days after taking zinc supplement or placebo
Method of measurement
autoanalyzer, enzymatic assay
3
Description
Creatinine
Timepoint
At the beginning of the study and 60 days after taking zinc supplement or placebo
Method of measurement
autoanalyzer, enzymatic assay
4
Description
Calcium
Timepoint
At the beginning of the study and 60 days after taking zinc supplement or placebo
Method of measurement
autoanalyzer
5
Description
phosphorus
Timepoint
At the beginning of the study and 60 days after taking zinc supplement or placebo
Method of measurement
autoanalyzer
6
Description
potassium
Timepoint
At the beginning of the study and 60 days after taking zinc supplement or placebo
Method of measurement
autoanalyzer
7
Description
sodium
Timepoint
At the beginning of the study and 60 days after taking zinc supplement or placebo
Method of measurement
autoanalyzer
8
Description
blood pressure
Timepoint
At the beginning of the study and 60 days after taking zinc supplement or placebo
Method of measurement
Gauge pressure gauge
9
Description
food intake
Timepoint
At the beginning of the study and 60 days after taking zinc supplement or placebo
Method of measurement
2-day 24-h diet recall
Secondary outcomes
1
Description
Appetite Status
Timepoint
At the beginning of the study and 60 days after taking zinc supplement or placebo
Method of measurement
2-day 24-h diet recall
Intervention groups
1
Description
Intervention group: one capsule containing 220 mg zinc sulfate with 50 mg elemental zinc per day, for 60 days, prepared by Al Hawi Tehran Pharmaceutical Company
Category
Treatment - Drugs
2
Description
Control group: one capsule containing cornstarch per day, for 60 days, prepared by Shiraz University of Pharmacy
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Golestan hospital
Full name of responsible person
Rezaee Eisa
Street address
Khuzestan Province, Ahvaz, Farvardin Blv
City
Ahvaz
Province
Khouzestan
Postal code
6135733118
Phone
+98 61 3374 3001
Fax
Email
Golestanjpspital@yahoo.com
Web page address
2
Recruitment center
Name of recruitment center
Razi Hospital
Full name of responsible person
Rezaee Eisa
Street address
Khuzestan Province, Ahvaz, Amaniye, Felestin St, Facing the governorate
City
Ahvaz
Province
Khouzestan
Postal code
۶۱۹۶۵۱۴۹۴۱
Phone
+98 61 3333 5935
Fax
+98 61 3333 6513
Email
razi-hos@ajums.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Akhlaghi Masoumeh
Street address
School Of Nutrition And Food Sciences, Razi Blvd, Shiraz
City
Shiraz
Province
Fars
Postal code
7153675541
Phone
+98 71 3725 1001
Fax
+98 71 3725 7288
Email
msm.akhlaghi@gmail.com
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Masoumeh Akhlaghi
Position
assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
School Of Nutrition And Food Sciences, Razi Blvd, Shiraz
City
Shiraz
Province
Fars
Postal code
7153675541
Phone
+98 71 3725 1001
Email
msm.akhlaghi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Masoumeh Akhlaghi
Position
assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
School Of Nutrition And Food Sciences, Razi Blvd, Shiraz
City
Shiraz
Province
Fars
Postal code
7153675541
Phone
+98 71 3725 1001
Email
msm.akhlaghi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Seyedeh Maryam Sadeghi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
School Of Nutrition And Food Sciences, Razi Blvd, Shiraz
City
Shiraz
Province
Fars
Postal code
7153675541
Phone
+98 71 3725 1001
Email
sadeghi2306@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
We will publish the data in the form of the article
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not 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