Objective: Determining the effect of Zinc Supplement on Sleep quality and fatigue 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 diagnosed by the doctor and 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. Those who did not use sleep medications before the intervention began but after the intervention begins and in the 70-day study period taking a sleep medication will be excluded. 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 PSQI sleep quality inventory and MFI fatigue inventory 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. In the elderly, Zinc supplementation control group will not be used. 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:IRCT2017080635110N2
Registration date:2017-09-07, 1396/06/16
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-09-07, 1396/06/16
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 Sleep quality and fatigue in the elderly
Public title
The effect of Zinc Supplementation on Sleep quality and fatigue 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 to diagnose a 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. Elderly people with low sleep quality; according to Pittsburgh sleep quality questionnaire, gaining a score of over 5 in the entire questionnaire is means poor sleep quality. "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; those who did not use sleep medications before the intervention began but after the intervention begins and in the 70-day study period taking a sleep medication will be excluded.
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)
Single 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.Relaxation exercises will be taught if aging after 70 days of low sleep quality or high fatigue is based on Pittsburgh Sleep Quality and MFI Inventory.
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
2017-08-13, 1396/05/22
Ethics committee reference number
IR.SHMU.REC.1396.80
Health conditions studied
1
Description of health condition studied
Sleep Quality
ICD-10 code
G47
ICD-10 code description
Sleep disorders
2
Description of health condition studied
Fatigue
ICD-10 code
R53
ICD-10 code description
Malaise and fatigue
Primary outcomes
1
Description
Sleep Quality
Timepoint
Before the intervention and 70 days after the intervention began
Method of measurement
PSQI standard questionnaire
2
Description
Fatigue
Timepoint
Before the intervention and 70 days after the intervention began
Method of measurement
MFI standard questionnaire
Secondary outcomes
empty
Intervention groups
1
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
2
Description
In the control group: No action is taken.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Ravand Health Center
Full name of responsible person
Abolfazl Afzali
Street address
Haram Stree,؛ Ravand
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
2nd Phase, Naji Abad
City
Kashan
4
Recruitment center
Name of recruitment center
Greater Fin Health Center
Full name of responsible person
Abolfazl Afzali
Street address
Above the bank, Greater Fin
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.comAfzali.A1373@shmu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)