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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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IRCT |
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Last refreshed on:
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22 February 2018 |
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Main ID: |
IRCT2017080635110N2 |
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Date of registration:
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2017-09-07 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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The effect of Zinc Supplementation on Sleep quality and fatigue in the elderly
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Scientific title:
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The effect of Zinc Supplementation on Sleep quality and fatigue in the elderly |
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Date of first enrolment:
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2017-09-23 |
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Target sample size:
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150 |
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Recruitment status: |
Complete |
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URL:
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http://en.irct.ir/trial/26634 |
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Study type:
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interventional |
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Study design:
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Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, 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.
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Phase:
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N/A
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Countries of recruitment
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Iran (Islamic Republic of)
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Contacts
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Name:
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Abolfazl Afzali
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Address:
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Shahroud University of Medical Sciences, Hafte-Tir Square
Shahroud
Iran (Islamic Republic of) |
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Telephone:
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+98 23 3239 5054 |
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Email:
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Afzali.a1373@shmu.ac.ir |
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Affiliation:
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Shahroud University of Medical Sciences |
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Name:
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Dr. Hussein Ebrahimi
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Address:
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Shahroud University of Medical Sciences, Hafte-Tir Square
Shahroud
Iran (Islamic Republic of) |
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Telephone:
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+98 23 3239 5054 |
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Email:
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ebrahimi@shmu.ac.ir |
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Affiliation:
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Shahroud University of Medical Sciences |
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Key inclusion & exclusion criteria
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Inclusion 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.
Exclusion criteria:
Age minimum:
60 years
Age maximum:
100 years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Condition 1: Sleep Quality. Condition 2: Fatigue.
Sleep disorders
Malaise and fatigue
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Sleep disorders
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Malaise and fatigue
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Intervention(s)
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Intervention 1: 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. Intervention 2: In the control group: No action is taken.
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Treatment - Drugs
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In the control group: No action is taken.
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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.
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Primary Outcome(s)
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Fatigue. Timepoint: Before the intervention and 70 days after the intervention began. Method of measurement: MFI standard questionnaire.
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Sleep Quality. Timepoint: Before the intervention and 70 days after the intervention began. Method of measurement: PSQI standard questionnaire.
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Source(s) of Monetary Support
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Vice chancellor for research - Shahroud University of Medical Sciences
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Ethics review
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Status: Approved
Approval date:
Contact:
Ethics Committee of Shahroud University of Medical Sciences
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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