Evaluation the effects of camel milk in spirometry parameters in over 6 year’s children with Cystic Fibrosis lung disease
Design
Two arm parallel groups randomised trial with blinded postoperative care and outcome assessment and performed on 60 patients aged over 6 years (30 people in each group)
Settings and conduct
This clinical trial is conducted on patients with Cystic Fibrosis who refer to Akbar Hospital clinic in Mashhad. Patients are randomly divided into two groups. The first group will receive only airway clearance therapies( Hypertonic Saline, Inhaled shortacting beta-2 agonist, Azithromycin) and 300 milliliter of cow milk per day as a placebo. The second group, in addition to drug treatment, will receive 300 milliliter of pasteurized camel milk per day for two months.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1. Over 6 year’s children with Cystic Fibrosis lung disease undergoing airway Clearance Treatment
2. The patient is not in the acute exacerbation phase of the disease
3. Those who have FEV1 more than 60% in spirometry
4. Those who have not a severe cough and sputum.
Exclusion criteria:
1.Those who are allergic to cow's milk
2.Those who do not cooperate properly in spirometry
3.Those who are hospitalized
Intervention groups
Control group: Patients will receive airway clearance therapies( Hypertonic Saline, Inhaled shortacting beta-2 agonist, Azithromycin) and 300 milliliter of cow milk per day as a placebo. Intervention group: in addition to drug treatment, will receive 300 milliliter of pasteurized camel milk per day for two months.
Main outcome variables
more than 10% increase in FEV1
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210914052477N1
Registration date:2022-01-09, 1400/10/19
Registration timing:registered_while_recruiting
Last update:2022-01-09, 1400/10/19
Update count:0
Registration date
2022-01-09, 1400/10/19
Registrant information
Name
Toktam Kheirabadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3841 3977
Email address
kheirabadit981@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-22, 1400/10/01
Expected recruitment end date
2022-05-22, 1401/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effects of camel milk in spirometry parameters in over 6 year’s children with Cystic Fibrosis lung disease
Public title
Evaluation the effects of camel milk on treatment of children with Cystic Fibrosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Over 6 year’s children with Cystic Fibrosis lung disease undergoing airway Clearance Treatment
The patient is not in the acute exacerbation phase of the disease
The patient has completed the Informed consent Form
Those who have FEV1 more than 60% in spirometry
Exclusion criteria:
Those who are allergic to cow's milk
Those who have a severe cough and sputum
Those who are hospitalized
Those who do not cooperate properly in spirometry
Age
From 6 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be assigned to either control or intervention groups according to a random number table provided by a computer (simple randomization). Allocation Concealment is done using sealed envelopes.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients and patient outcome assessment will be unaware of Intervention and control groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Central Building of Mashhad University of Medical Sciences (Ghorshi),Daneshgah 16, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2021-08-15, 1400/05/24
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1400.290
Health conditions studied
1
Description of health condition studied
Cystic Fibrosis lung disease in children
ICD-10 code
E84
ICD-10 code description
Cystic fibrosis
Primary outcomes
1
Description
Patients with Expiratory Volume in First Second (FEV1) greater than 60%
Timepoint
At the beginning of the study (before the intervention) and two months after beginning milk use (after the intervention)
Method of measurement
spirometer device
Secondary outcomes
1
Description
Percentage of patient whose Forced Expiratory Volume in First Second (FEV1) increase 10%
Timepoint
At the beginning of the study (before the intervention) and two months after beginning milk use (after the intervention)
Method of measurement
spirometer device
Intervention groups
1
Description
Control group: Patients will receive airway clearance therapies( Hypertonic Saline, Inhaled shortacting beta-2 agonist, azithromycin) and 300 milliliter of cow milk per day as a placebo.
Category
Treatment - Drugs
2
Description
Intervention group: In addition to drug treatment, will receive 300 milliliter of pasteurized camel milk per day for two months.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Akbar children Hospital
Full name of responsible person
Dr Seyed Javad Sayedi
Street address
Akbar children Hospital, In front of Shahid Kave 14, Shahid Kaveh sq
City
Mashhad
Province
Razavi Khorasan
Postal code
9139963185
Phone
+98 51 3870 9202
Email
SayediJ@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah street
City
mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 2081
Email
ramresearch@mums.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
100
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
Dr Seyed Javad Sayedi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Akbar children Hospital, In front of Shahid Kave 14, Shahid Kaveh sq
City
Mashhad
Province
Razavi Khorasan
Postal code
9139963185
Phone
+98 51 3870 9202
Email
SayediJ@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Seyed Javad Sayedi
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Akbar children Hospital, In front of Shahid Kave 14, Shahid Kaveh sq
City
Mashhad
Province
Razavi Khorasan
Postal code
9139963185
Phone
+98 51 3870 9202
Email
SayediJ@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Seyed Javad Sayedi
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Akbar children Hospital, In front of Shahid Kave 14, Shahid Kaveh sq
City
Mashhad
Province
Razavi Khorasan
Postal code
9139963185
Phone
+98 51 3870 9202
Email
SayediJ@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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All data can be shared after patients are made unidentifiable.
When the data will become available and for how long
Data can be accessible 6 months after results are published.
To whom data/document is available
Data will be available for researchers in universities and other scientific institutes.
Under which criteria data/document could be used
Carrying out analysis on data is permitted.
From where data/document is obtainable
Data can be accessible through sending an email to the corresponding author.
What processes are involved for a request to access data/document
After sending a request email to the corresponding author, data will be sent in 1 month.