The aim of this study: Comparison of the effect of zinc sulfate- hydroxyzine and hydroxyzine alone on malnutrition indices in hemodialysis patients. Study design: After explaining the purpose of the study and obtaining the informed consent, patients under hemodialysis will be allocated into A and B groups. Randomization will be performed using random block sizes of 4. The study is single-center, phase 3 trial and patients and physician will be blind about the type of drugs. Inclusion criteria: More than 15 years old; history of at least 6 months hemodialysis. Exclusion criteria: zinc supplements usage; nephrotic syndrome; cancer. Sample size: 84 patients will participate in the study with 42 patients in each group. Study groups: Intervention group: one zinc sulfate capsule (220 mg) daily and one hydroxyzine tablet (25 mg) daily for 8 weeks. Control group: one hydroxyzine tablet (25 mg) daily for 8 weeks. Primary outcomes: BMI, Albumin, Cholesterol, Hemoglobine, Creatinin, Arm durchmesser
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017102136703N2
Registration date:2017-11-08, 1396/08/17
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-11-08, 1396/08/17
Registrant information
Name
Elahe Hoseini
Name of organization / entity
Shahroud University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23233390433
Email address
hossaini@shmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shahroud University of Medical Sciences
Expected recruitment start date
2017-11-22, 1396/09/01
Expected recruitment end date
2018-11-22, 1397/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of zinc sulfate- hydroxyzine and hydroxyzine alone on malnutrition indices in hemodialysis patients: A clinical trial
Public title
Effect of zinc sulfate- hydroxyzine and hydroxyzine alone on malnutrition indices in hemodialysis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: More than 15 years old; history of at least 6 months hemodialysis.
Exclusion criteria: Zinc supplements usage; nephrotic syndrome; cancer
Age
From 15 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
84
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee, Vice chancellor for research, Shahroud University of Medical Sciences
Street address
Shahroud University of Medical Sciences, Hafte-Tir Square
City
Shahroud
Postal code
3613773955
Approval date
2017-08-25, 1396/06/03
Ethics committee reference number
IR.SHMU.REC.1396.63
Health conditions studied
1
Description of health condition studied
End stage renal disease, hemodialysis
ICD-10 code
N18
ICD-10 code description
Chronic renal failure
Primary outcomes
1
Description
BMI
Timepoint
Before the intervention and 4 and 8 weeks after intervention
Method of measurement
Wt(kg)/Ht(m2)
2
Description
Albumin
Timepoint
Before the intervention and 4 and 8 weeks after intervention
Method of measurement
Autoanalyzer
3
Description
Cholesterol
Timepoint
Before the intervention and 4 and 8 weeks after intervention
Method of measurement
Autoanalyzer
4
Description
Hemoglobine
Timepoint
Before the intervention and 4 and 8 weeks after intervention
Method of measurement
Cell Blood Count with sismex k1000
5
Description
Creatinin
Timepoint
Before the intervention and 4 and 8 weeks after intervention
Method of measurement
Autoanalyzer
6
Description
Arm durchmesser
Timepoint
Before the intervention and 4 and 8 weeks after intervention
Method of measurement
Meter
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: one zinc sulfate capsule (220 mg) daily and one hydroxyzine tablet (25 mg) daily for 8 weeks
Category
Treatment - Drugs
2
Description
Control group: one hydroxyzine tablet (25 mg) daily for 8 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossein hospital
Full name of responsible person
Dr Monire Amerian
Street address
Imam Hossein Hospital, End of Ayatollah Towhidi avenue, Shahroud
City
Shahroud
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Shahroud University of Medical Sciences
Full name of responsible person
Mohammad Hasan Emamian
Street address
Shahroud University of Medical Sciences, 7 Tir square, Shahroud
City
Shahroud
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Shahroud 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
Shahroud University of Medical Sciences
Full name of responsible person
Azita Roohi
Position
Medical Student
Other areas of specialty/work
Street address
Shahroud University of Medical Sciences, Hafte-Tir Square, Shahroud
City
Shahroud
Postal code
3613773955
Phone
+98 23 3239 1796
Fax
Email
hossaini@shmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Dr Monire Amerian
Position
Nephrologist
Other areas of specialty/work
Street address
Imam Hossein Hospital, End of Ayatollah Towhidi avenue
City
Shahroud
Postal code
3613773955
Phone
+98 23 3239 1796
Fax
Email
amerian@shmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Azita Roohi
Position
Medical student
Other areas of specialty/work
Street address
Shahroud University of Medical, Hafte-Tir Square,Shahroud
City
Shahroud
Postal code
3613773955
Phone
+98 23 3239 1796
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)