In this study 100 elderly person from nursing homes in Kermanshah will be divided into two case and control groups after the initial screening for the diseases and other criteria. The groups will be matched in case of the history of dietary supplements. Daily dietary supplement capsules (Multivitamin-Mineral) will be administrated for 3 months. Food supplement will be given to the subjects under nurses’ supervision. There will be no intervention for control group. In order to control confounding variables double-blind random allocation method will be applied
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201205259856N1
Registration date:2015-11-13, 1394/08/22
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-11-13, 1394/08/22
Registrant information
Name
Yahya Pasdar
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1828 1991
Email address
yahya.pasdar@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice – Chancellery of Research & Technology Affairs Kermanshah University of Medical sciences
Expected recruitment start date
2015-10-23, 1394/08/01
Expected recruitment end date
2017-02-19, 1395/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of using nutritional supplements on quality of life and nutritional status of elders Cost utility analysis of interventions
Public title
Elderly Nutrition
Purpose
Supportive
Inclusion/Exclusion criteria
Elderly subjects who are residents in Kermanshah state nursing home at least for a month, will be enrolled in this study. Exclusion criteria include elderly who are suffering from chronic diseases, infectious diseases and who take dietary supplements.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kermanshah University of Medical Sciences
Street address
Faculty of Health,Nutrition Department
City
Kermanshah
Postal code
Approval date
2015-01-13, 1393/10/23
Ethics committee reference number
45250
Health conditions studied
1
Description of health condition studied
Elderly nutrition
ICD-10 code
E63.9
ICD-10 code description
Nutritional deficiency, unspecified
Primary outcomes
1
Description
The level of vitamins serum
Timepoint
3 month
Method of measurement
Biochemical tests using standard methods
Secondary outcomes
1
Description
Weight change
Timepoint
3 month
Method of measurement
device of Body Analyzer
Intervention groups
1
Description
Daily dietary supplement capsules (Multivitamin-Mineral) will be administrated for 3 months. Food supplement will be given to the subjects under nurses’ supervision.
Category
Treatment - Drugs
2
Description
There will be no intervention for control group
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
School of Public Health
Full name of responsible person
Dr yahya pasdar
Street address
kermanshah-Next Farabi Hospital
City
kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences, Vice – Chancellery of Research & Technology
Full name of responsible person
Dr Farid Najafi
Street address
Kermanshah.shahid Beheshti Blvd. Building No 2.University of Medical Sciences
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah University of Medical Sciences, Vice – Chancellery of Research & Technology
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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr Yahya Pasdar
Position
Ph.D
Other areas of specialty/work
Street address
Department of Nutrition, School of Health
City
kermanshah
Postal code
Phone
+98 83 3828 1991
Fax
Email
Yahya.pasdar@kums.ac.ir; yahya.pasdar@gmail.com
Web page address
www.Drpasdar.com
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)