Evaluation of the effect of zinc supplement on quality of life, quality of sleep and malnutrition indicators
Design
Clinical trial with control group, with parallel group, double-blind, randomized. For randomization we use SPSS software version 25.
Settings and conduct
Eighty hemodialysis patients referred to the dialysis center of Isfahan Khorshid Hospital will be allocated into two groups (n=40 in each group). Subjects in intervention group receive zinc gluconate supplement and subject in control group receive placebo for 12 weeks.
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
Present study contains two groups. Subjects in intervention group receive 30 mg/d of zinc gluconate. A placebo similar to zinc gluconate supplement is administer to control group. placebo contains starch.
Main outcome variables
life Quality, sleep Quality and Malnutrition indicators changes, serum zinc level
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130903014551N10
Registration date:2020-10-19, 1399/07/28
Registration timing:registered_while_recruiting
Last update:2020-10-19, 1399/07/28
Update count:0
Registration date
2020-10-19, 1399/07/28
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
2020-09-22, 1399/07/01
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
The effect of zinc supplementation on life quality, sleep quality and malnutrition indicators 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
Other diseases such as cancer, inflammatory diseases and advanced liver disease
Exclusion criteria:
consumption of calcium and vitamin D supplements
Enteral and Parenteral Feeding
smoking
pregnancy and lactation
consumption of drugs that affect dependent variables
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
Using SPSS software and based on the code assigned to each person, by stratified randomization based on BMI (between 25-25 and 25-30) and gender, subjects are assigned in the intervention and control groups Placed
Blinding (investigator's opinion)
Double blinded
Blinding description
Bottles contained zinc supplements and placebos were coded as A and B by person other than researcher to ensure researcher and participants are not aware 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.1399.407
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
sleep quality
Timepoint
quality of sleep assessment Before and immediately after intervention
Method of measurement
pitssburgh questionnaire completed by the individual
2
Description
life quality
Timepoint
quality of life assessment Before and immediately after intervention
Method of measurement
quality of life (HRQOL) questionnaire completed by the individual