The present study aimed to evaluate the effects of nano-curcumin on CF patients in order to achieve the intrinsic and extrinsic effects of curcumin on the inflammatory process in these patients.
Design
This was a double-blind, randomized, placebo-controlled clinical trial.
Settings and conduct
Akbar Children's Hospital in Mashhad, Iran.
Participants/Inclusion and exclusion criteria
Inclusion Criteria
The inclusion criteria of the study were as follows: 1) one or more typical phenotypic features of CF and a minimum of an elevated sweat chloride concentration on two/more occasions or two mutations known to cause CF on separate alleles; 2) age of 5-18 years; 3) pulmonary and gastrointestinal involvement; 4) ability to perform spirometry maneuvers and the minimum FEV1 of ≥30% compared to the same age, gender, and height in the normal population; 5) the percentage of oxygen saturation based on pulse the oximetry of ≥90% at room temperature; 6) no cardiovascular, hepatic, and renal failure; 7) absence of celiac disease and rheumatoid arthritis; 8) no acute pulmonary exacerbation requiring hospitalization within the past four weeks; 9) absence of acute respiratory tract infection; 10) informed consent for participation.
Exclusion Criteria
The exclusion criteria of the study were the lack of adherence to the drug regimen and presence of drug tolerance.
Intervention groups
The study population consisted of the patients with known CF referring to the Cystic Fibrosis Clinic at Akbar Children's Hospital.
Main outcome variables
Evaluation of inflammation at three levels: 1) systemic by assessing IL-8 as an inflammatory agent, IL-10 as an anti-inflammatory agent, and hsCRP level in the blood samples; 2) pulmonary with the neutrophil count, and bacterial/viral culture on the nasopharyngeal swab; 3) gastrointestinal with the calprotectin level in the fecal samples.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200705048018N1
Registration date:2020-07-10, 1399/04/20
Registration timing:registered_while_recruiting
Last update:2020-07-10, 1399/04/20
Update count:0
Registration date
2020-07-10, 1399/04/20
Registrant information
Name
Saeedeh Talebi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3842 0718
Email address
talebis961@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-21, 1399/03/01
Expected recruitment end date
2020-11-21, 1399/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effects of curcumin as a Nutritional Strategy on Clinical and Inflammatory Factors in Children with Cystic Fibrosis
Public title
Evaluation of using curcumin as a nutritional strategy on clinical finding and inflammatory markers in children with cystic fibrosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
One or more typical phenotypic features of CF and a minimum of an elevated sweat chloride concentration on two/more occasions or two mutations known to cause CF on separate alleles
Age of 5-18 years
Pulmonary and gastrointestinal involvement
Ability to perform spirometry maneuvers and the minimum FEV1 of ≥30% compared to the same age, gender, and height in the normal population
The percentage of oxygen saturation based on pulse oximetry of ≥90% at room temperature
No cardiovascular, hepatic, and renal failure
Absence of celiac disease and rheumatoid arthritis
No acute pulmonary exacerbation requiring hospitalization within the past four weeks
Absence of acute respiratory tract infection
Informed consent for participation
Exclusion criteria:
The lack of adherence to the drug regimen
Presence of drug intolerance
Age
From 5 years old to 18 years old
Gender
Both
Phase
1
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
60
More than 1 sample in each individual
Number of samples in each individual:
30
30
Randomization (investigator's opinion)
Randomized
Randomization description
All known cystic fibrosis patients referred to the clinic were included in the study based on the inclusion criteria. After that, spirometry was down and patients were divided into two groups using FEV1with 40% cutoff range: Severe lung disease (FEV1 lower than 40%) and Non severe lung disease(FEV1 higher than 40%).(Stratified randomization based on disease severity). Following that, simple random sampling method was used to select the patients from each groups and each stages divided in to two groups of case and control by using a table of random numbers .
Blinding (investigator's opinion)
Double blinded
Blinding description
The curcumin and placebo glasses were labeled A and B, respectively and made available to the patients through the double-blind design.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Research in Mashhad University of Medical Sciences
Street address
Ferdowsi Blvd., Mashhad University of Medical Sciencess
City
Mashhad
Province
Razavi Khorasan
Postal code
02181455618
Approval date
2019-07-06, 1398/04/15
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1399.144
Health conditions studied
1
Description of health condition studied
Cystic Fibrosis
ICD-10 code
J44
ICD-10 code description
Other chronic obstructive pulmonary disease
Primary outcomes
1
Description
Inflammation at three levels: Systemic Inflammation, Pulmonary Inflammation, Gastrointestinal Inflammation.
Timepoint
Before and after three months of trial
Method of measurement
1) Systemic inflammation by assessing IL-8 as an inflammatory agent, IL-10 as an anti-inflammatory agent, and hsCRP level in the blood samples; 2) Pulmonary inflammation with the neutrophil count, and bacterial/viral culture on the nasopharyngeal swab; 3) Gastrointestinal inflammation with the calprotectin level in the fecal samples.
Secondary outcomes
1
Description
Evaluation of pulmonary function
Timepoint
Before and after three months of trial
Method of measurement
Spirometer
2
Description
Quality of life
Timepoint
Before and after three months of trial
Method of measurement
Cystic Fibrosis Questionnaire(CFQ)
Intervention groups
1
Description
Intervention group: Nano-curcumin (Nano Sina Drug Company, Iran) was prepared as nanomicelle in the form of 70 milligrams of drops in 1 cc. To adjust the drug dose for different ages and considering that the maximum acceptable dose based with the most significant impact and minimum side-effects was 80 milligrams, the required amount was obtained for each subject based on the ratio of the body surface area of the patients. The curcumin and placebo glasses were labeled A and B, respectively and made available to the patients through the double-blind design. The duration of the treatment period was three months.
Category
Treatment - Drugs
2
Description
Control group:The placebo was made of polysorbate with the same color and taste. Placebo glasses were labeled A and B, respectively and made available to the patients through the double-blind design. The duration of the treatment period was three months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Akbar Children's Hospital
Full name of responsible person
Seyed Ali Jafari
Street address
Namaz Blvd., Zakaria Land., Akbar Children hospital., Mashhad Town
City
Mashhad
Province
Razavi Khorasan
Postal code
30007273010022
Phone
+98 51 3871 3801
Email
ak.pr@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Ahmad Reza Bahrami
Street address
Azadi Squar; Ferdowsi University of Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948974
Phone
+98 51 3880 2420
Email
vcr@um.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
80
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Saeedeh Talebi
Position
Pediatrician, PhD Student of Nutrition
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
No. 2.12, Taleghani 7., Ahmad Abad Street., Mashhad Town
City
Mashhad
Province
Razavi Khorasan
Postal code
9176756436
Phone
+98 51 3842 0718
Email
talebis@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Saeedeh Talebi
Position
Pediatrician, PhD Student of Nutrition
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
No. 2.12, Taleghani 7., Ahmad Abad Street., Mashhad Town
City
Mashhad
Province
Razavi Khorasan
Postal code
9176756436
Phone
+98 51 3842 0718
Email
talebis961@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Saeedeh Talebi
Position
Pediatrician,PhD Student of Nutrition
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
No. 2.12, Taleghani 7., Ahmad Abad Street., Mashhad Town
City
Mashhad
Province
Razavi Khorasan
Postal code
9176756436
Phone
+98 51 3842 0718
Fax
Email
talebis961@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data can be shared
When the data will become available and for how long
since 1400 years
To whom data/document is available
Academic and scientific institutions
Under which criteria data/document could be used
I haven't decided on that yet
From where data/document is obtainable
Saeedeh Talebi
What processes are involved for a request to access data/document
Send an email to the author responsible for the project