Effect of curcumin supplementation on anthropometric measurments, quality of life, frequencies of hospitalization, lung infection and antibiotic therapies in children with cystic fibrosis
In this randomized clinical trial, 40 children with cystic fibrosis will be recruited. Inclusion criteria are children with cystic fibrosis 5-18 years old . Exclusion criteria include diabetes, cirrhosis, and hypoalbuminena , severe respiratory failure dependent to oxygen therpay,hypoalbuminemia,intolerance of curcumin supplemnation. On the basis of age and gender, patients are randomly assigned in to Curcumin group, receiving 2 nano curcumin capsules and 3 capsules 80 mg children <10 years and >10 years respectively or the placebo group receiving place capsules for 6 months. Primary outcomes are Pulmonary infection, duration of hospitalization,Oral or IV antibiotics administration. Secondary outcomes are anthropometric measurements, quality of life and gastrointestinal symptoms of children with cystic fibrosis.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016022826798N1
Registration date:2017-08-26, 1396/06/04
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-08-26, 1396/06/04
Registrant information
Name
Elnaz Faramarzi
Name of organization / entity
liver and Gastrointestinal Research Center, Tabriz University Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3336 9331
Email address
faramarzie@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
liver and Gastrointestinal diseases research center, tabriz university of medical scinces
Expected recruitment start date
2016-07-22, 1395/05/01
Expected recruitment end date
2017-10-23, 1396/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of curcumin supplementation on anthropometric measurments, quality of life, frequencies of hospitalization, lung infection and antibiotic therapies in children with cystic fibrosis
Public title
Effects of curcumin in children with cystic fibrosis
Purpose
Supportive
Inclusion/Exclusion criteria
inclusion criteria:children with cystic fibrosis (age 5-18 year)
exclusion criteria:history of diabetes;cirhosis;hypoalbuminemia; severe respiratory failure dependent to oxygen therapy;intolerance of curcumin supplementation
Age
From 5 years old to 18 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
simple randomization
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics comitte of Tabriz University of Medical Sciences
Street address
3rd floore, The Vice Chancellor for Research .Central building no2, Tabriz University of Medical Sciences, Golghasht street, Tabriz
City
Tabriz
Postal code
Approval date
2016-04-11, 1395/01/23
Ethics committee reference number
IR.TBZMED.REC.1395.324
Health conditions studied
1
Description of health condition studied
cystic fibrosis
ICD-10 code
J40-J47
ICD-10 code description
Cystic fibrosis, unspecified
Primary outcomes
1
Description
Pulmonary infection
Timepoint
before and after intervention
Method of measurement
questionnaire
2
Description
duration of hospitalization
Timepoint
before and after intervention
Method of measurement
questionnaire
3
Description
oral or Iv antibiotics administration
Timepoint
before and after intervention
Method of measurement
questionnaire
Secondary outcomes
1
Description
height
Timepoint
before and after intervention
Method of measurement
mounted tape
2
Description
weight
Timepoint
before and after intervention
Method of measurement
Seca scale
3
Description
quality of life
Timepoint
before and after intervention
Method of measurement
Pedsql4 questionnaire
4
Description
body mass index
Timepoint
before and after intervention
Method of measurement
weight (kg)/height (m)2
5
Description
gastrointestinal disease symptoms
Timepoint
before and after intervention
Method of measurement
questinnnaire
Intervention groups
1
Description
Patients in Curcumin group aged ≤10 year will receive 2 nano curcumin capsules and children with age >10 year will receive 3 nano curcumin capsules for 6 months.
Category
Other
2
Description
Patients in placebo group aged 10 or >10 year will receive 2 nano curcumin capsules and children with >10 year will receive placebo capsules for 6 months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Children Cure and Health hospital
Full name of responsible person
Ziba sameni
Street address
sheshghalan street, Children Cure and Health hospital
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
liver and gastrointestinal diseases research center, Tabriz University of medical sciences
Full name of responsible person
Dr.rafie
Street address
first floor, Liver and Gastrointestinal Diseases Research Center, Imam Reza Hospital, Golghasht Street , Tabriz
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
liver and gastrointestinal diseases research center, Tabriz University of medical sciences