Protocol summary

Summary
Objectives: Annually, respiratory infection diseases are those of the leading cause of deaths among children. Dietary supplements such as conjugated linoleic acid (CLA) are suggested for the treatment of respiratory infections. CLA supplements have several properties including antioxidant activity, anti -cancer, immune system regulation, anti-hypertensive, anti-diabetic and cholesterol reduction, that may be effect on improving respiratory infections in children. The purpose of study is the effect of CLA on improving the respiratory infections in children aged 1 - 5 years old. Design: Sixty children with acute respiratory infection aged 1- 5 years will be selected for study into two groups (30 test groups and 30 control groups). Setting and conduct: After obtaining consent from families, general information, anthropometric factors (height, weight and body mass index) and respiratory symptoms (including cough, fever, sore throat, and respiratory distress) will be collected and patient’s appetite will also be tested. Participants including major eligibility criteria: Children with pulmonary infection aged 1-5 years old, in Buali Hospital, Ardabil. Those with malnutrition and chronic disease will be excluded. Intervention: Two grams of CLA supplement daily will be given to test group for two weeks. Main outcome measures (variables): Weight, body mass index and symptoms of respiratory infection were measured at the end of two weeks period, and then both groups will be compared.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201402235144N6
Registration date: 2014-07-20, 1393/04/29
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-07-20, 1393/04/29
Registrant information
Name
Ali Nemati
Name of organization / entity
Ardabil University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 45 3351 0052
Email address
a.nemati@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Ardabil University of Medical Sciences, Daneshgah Avenue, Ardabil, Iran.
Expected recruitment start date
2014-03-21, 1393/01/01
Expected recruitment end date
2014-04-20, 1393/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of conjugated linoleic acid supplementation in improving of children pulmonary infection at 1-5 years old in Boali Hospital, Ardabil
Public title
The effect of conjugated linoleic acid supplementation in improving of children pulmonary infection
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Children with pulmonary infection in 1-5 years old; in Buali Hospital; Ardabil Exclusion criteria: Children with malnutrition and chronic disease
Age
From 93 years old to 93 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 60
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

1

Registry name
Secondary trial Id
Registration date
2017-11-21, 1396/08/30

Ethics committees

1

Ethics committee
Name of ethics committee
Ethic Committee of Ardabil University of Medical Sciences
Street address
Ethic Committee of Ardabil University of Medical Sciences, Vice Chancellor for Research, Ardabil University of Medical Sciences, Dneshgah Avenue, Ardabil, Iran.
City
Ardabil
Postal code
5618985991
Approval date
2013-05-26, 1392/03/05
Ethics committee reference number
9107

Health conditions studied

1

Description of health condition studied
Children with lower respiratory tract infection.
ICD-10 code
J20, J21,
ICD-10 code description
Other acute lower respiratory infections

Primary outcomes

1

Description
Respiratory infection
Timepoint
At the end of treatment
Method of measurement
Signs and symptoms related to diease

Secondary outcomes

1

Description
Weight
Timepoint
At the beginning and after two weeks intervention
Method of measurement
Digital scales

2

Description
Body Mass Index
Timepoint
At the beginning and after two weeks intervention
Method of measurement
Stadiometers

3

Description
Appetite
Timepoint
At the beginning and two weeks after the intervention
Method of measurement
Questionnaire

4

Description
Cough
Timepoint
At the beginning and after two weeks intervention
Method of measurement
Questionnaire

5

Description
Fever
Timepoint
At the beginning and after two weeks intervention
Method of measurement
Questionnaire

6

Description
Sore throat
Timepoint
At the beginning and after two weeks intervention
Method of measurement
Questionnaire

7

Description
Respiratory distress
Timepoint
At the beginning and after two weeks intervention
Method of measurement
Questionnaire

Intervention groups

1

Description
Intervention group: Two grams of conjugated linoleic acid for 2 weeks.
Category
Treatment - Drugs

2

Description
Control group: Was not given anything
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Ardabil University of Medical Science
Full name of responsible person
Ali Nemati
Street address
Nutrition Biochemistry Dept., Faculty of Medicine, Ardabil University of Medical Science, Daneshgah Avenue, Ardabil, Iran.
City
Ardabil

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research Ardabil University of Medical Sciences
Full name of responsible person
Hadi Piri
Street address
Vice Chancellor for Research Ardabil University of Medical Sciences, Ardabil University of Medical Sciences, Daneshgah Avenue, Ardabil, Iran.
City
Ardabil
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 Ardabil 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
Ardabil University Of Medical Science
Full name of responsible person
Parisa Ahadi Kalkhoran
Position
Studen
Other areas of specialty/work
Street address
Buali Hospital, Maidan Varzeh, Ardabil
City
Ardabil
Postal code
5613643197
Phone
+98 45 1771 3310
Fax
+98 45 1223 3055
Email
ali.nemati@arums.ac.ir
Web page address
www.arums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Manoucher Barakl
Position
Specialization in MD
Other areas of specialty/work
Street address
Children Dept., Faculty of Medicine, Ardabil University of Medical Sciences, Daneshgah Avenue, Ardabil, Iran.
City
Ardabil
Postal code
5919711111
Phone
+98 45 1551 0052
Fax
+98 45 1551 0057
Email
m.barak@arums.ac.ir
Web page address
http//:www.arums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Ali Nemati
Position
Ph.D in Nutrition
Other areas of specialty/work
Street address
Nutritional Biochemistry Dept., Faculty of Medicine, Ardabil University of Medical Sciences, Daneshgah Avenue, Ardabil, Iran
City
Ardabil
Postal code
5619711111
Phone
+98 45 1551 0052
Fax
+98 45 1551 0057
Email
ali.nemati@arums.ac.ir
Web page address
http//:www.arums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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