Objective: Determining the effect of Zinc Supplement on mood, anxiety and quality of life in the elderly. Design: This study is a clinical trial study in which questioners and data analysts have been blinded. Study population: Seniors 60 years and older in Kashan. Main inclusion criteria: Having full satisfaction to participate in this study، Iranian citizenship، not using Zinc Supplement، no cognitive impairment، lack of liver and intestinal diseases as well as the absence of known cases of depression and anxiety both of these are diagnosed by the doctor. People with serum zinc levels in them based on experiment within be normal range. Main exclusion criteria: The lack of cooperation and refusal of the elderly to continue to participate in research، consumption of Zinc Supplement in the control group during the course of 70 days of intervention، The occurrence of severe stress in both groups during the study. For city-level sampling first, the health centers that cover the population groups they are considered as clusters، Then, relative to the number of the elderly located in each cluster 150 elderly they will be selected by stratified sampling. To measure serum zinc level 5 ml venous blood sample taken in fasting conditions of the elderly both intervention and control groups and sent to lab; Then GDS depression inventory، Anxiety BAI and quality of life SF-36 will be completed by the elderly. For the elderly of the intervention group for 10 weeks Zinc supplement 30 milligrams which will be given in the form of Zinc Gluconate. After 70 days serum zinc level will be measured again as well as questionnaires will be completed by the elderly.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017071635110N1
Registration date:2017-08-01, 1396/05/10
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-08-01, 1396/05/10
Registrant information
Name
Abolfazl Afzali
Name of organization / entity
Shahroud University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 5551 2727
Email address
afzali.a1373@shmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research (Research and Technology), Shahroud University of Medical Sciences
Expected recruitment start date
2017-09-23, 1396/07/01
Expected recruitment end date
2018-01-21, 1396/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Zinc Supplementation on mood, anxiety and quality of life in the elderly of Kashan
Public title
Investigating the effect of Zinc Supplement on mood, anxiety and quality of life in the elderly
Purpose
Prevention
Inclusion/Exclusion criteria
The inclusion criteria for this study are: having full satisfaction to participate in this study; seniors 60 years and older; Iranian citizenship; the ability to speak Farsi and answer questions; not using Zinc Supplement; no cognitive impairment (for the elderly with literacy based on the MMSE questionnaire score 25 and more and for the illiterate elderly, based on the AMTS questionnaire, score 7 and more); lack of liver and intestinal diseases as well as the absence of known cases of depression and anxiety both of these are diagnosed by the doctor. People with serum zinc levels in them based on experiment within be normal range; in that sense people whose serum zinc level is higher or lower than normal range do not enter the study.The exclusion criteria for this study are: the lack of cooperation and refusal of the elderly to continue to participate in research; the consumption of zinc supplement in the control group during the course of 70 days of intervention; the occurrence of severe stress, such as hospitalization or death of relatives in both groups during the study.
Age
From 60 years old to 100 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Select clusters is based on socioeconomic conditions of the people of Kashan city. Random assignment to test and control groups based on randomized software in the form of four blocks will be grouped and in two groups A (intervention) And group B (control) will be placed. Zinc measurements in a laboratory in Kashan and will be done by auto-analysis. In order to comply with ethical principles elderly both groups which after 70 days of intervention their zinc level is below normal To the expert physician will be referred.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahroud University of Medical Sciences
Street address
Shahroud University of Medical Sciences, Hafte-Tir Square
City
Shahroud
Postal code
Approval date
2017-06-20, 1396/03/30
Ethics committee reference number
IR.SHMU.REC.1396.42
Health conditions studied
1
Description of health condition studied
Mood (depression)
ICD-10 code
F30-F39
ICD-10 code description
Mood [affective] disorders
2
Description of health condition studied
Anxiety
ICD-10 code
F06.4
ICD-10 code description
Organic anxiety disorder
3
Description of health condition studied
Quality of life
ICD-10 code
Y98
ICD-10 code description
Lifestyle-related condition
Primary outcomes
1
Description
Mood(depression)
Timepoint
Before the intervention and 70 days after the intervention began
Method of measurement
GDS standard questionnaire
2
Description
Anxiety
Timepoint
Before the intervention and 70 days after the intervention began
Method of measurement
BAI standard questionnaire
Secondary outcomes
1
Description
Quality of life
Timepoint
Before the intervention and 70 days after the intervention began
Method of measurement
SF-36 standard questionnaire
Intervention groups
1
Description
In the control group: No action is taken.
Category
N/A
2
Description
In the intervention group: Zinc supplemented pill is a zinc gluconate form and it contains 30 mg zinc for 70 days will be given to elderly group intervention. One day one of these pills after lunch meal is used together with a glass of water.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ravand health center
Full name of responsible person
Abolfazl Afzali
Street address
Ravand _ Haram Street
City
Kashan
2
Recruitment center
Name of recruitment center
Sadoughi health center
Full name of responsible person
Abolfazl Afzali
Street address
Gendarmerie Street
City
Kashan
3
Recruitment center
Name of recruitment center
Imam Ali health center
Full name of responsible person
Abolfazl Afzali
Street address
Naji Abad _ Two Phases
City
Kashan
4
Recruitment center
Name of recruitment center
Greater Fin health center
Full name of responsible person
Abolfazl Afzali
Street address
Greater Fin_Above the bank
City
Kashan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research - Shahroud University of Medical Sciences
Full name of responsible person
Dr. Mohammad-Hassan Emamian
Street address
Shahroud University of Medical Sciences, Hafte-Tir Square
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
Abolfazl Afzali
Position
Master of Geriatric Nursing
Other areas of specialty/work
Street address
Shahroud University of Medical Sciences, Hafte-Tir Square
City
Shahroud
Postal code
Phone
+98 23 3239 5054
Fax
Email
Afzali.a1373@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. Hussein Ebrahimi
Position
Ph.D. Nursing
Other areas of specialty/work
Street address
Shahroud University of Medical Sciences, Hafte-Tir Square
City
Shahroud
Postal code
Phone
+98 23 3239 5054
Fax
Email
ebrahimi@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
Abolfazl Afzali
Position
Master of Geriatric Nursing
Other areas of specialty/work
Street address
Shahroud University of Medical Sciences, Hafte-Tir Square
City
Shahroud
Postal code
Phone
+98 23 3239 5054
Fax
Email
Afzali.A1373@gmail.com; Afzali.A1373@shmu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)