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Trial registered on ANZCTR


Registration number
ACTRN12616000492459
Ethics application status
Approved
Date submitted
5/04/2016
Date registered
14/04/2016
Date last updated
17/01/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The prophylactic potential of a Mediterranean dietary pattern enriched with oily fish in improving respiratory function in asthmatic children.
Scientific title
The prophylactic potential of a Mediterranean dietary pattern enriched with oily fish in improving respiratory function in asthmatic children: a randomized control trial.
Secondary ID [1] 288883 0
NONE
Universal Trial Number (UTN)
U1111-1181-3989
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
CHILDHOOD ASTHMA 298183 0
Condition category
Condition code
Diet and Nutrition 298345 298345 0 0
Other diet and nutrition disorders
Respiratory 298346 298346 0 0
Asthma
Respiratory 298347 298347 0 0
Normal development and function of the respiratory system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention group will be instructed to consume 2 fatty fish meals (at least 150g cooked fish)/week as part of the Mediterranean diet for a period of 6 months. Emphasis to consume fatty fish only ( such as sardines, salmon, trout, mackerel etc) and no lean fish or seafood. Prior to commencement participants will be provided with an information sheet and consent form. At baseline and at 6 months during usual medical consultations, children will be assessed using anthropometry, spirometry, exhaled Nitric Oxide Analysis. And children together with parents will complete socio-demographics, Asthma Control Questionnaire, Paediatric Asthma Quality of life Questionnaire and food frequency questionnaires (requiring approximately 30 mins) as well as biochemical tests. During enrolment, a telephone-interview (lasting approximately 60 minutes) will be conducted by the dietitian to collect medical, dietary and lifestyle information. Dietary advice based on the Greek Mediterranean dietary guidelines ( Greek Ministry of Health & Welfare, 1999) including instructions on the dietary intervention will be explained to parents. Participants will be monitored fortnightly via telephone, text, e-mails and face-to-face consultations from the dietitian to address any problems relating to dietary adherence
Intervention code [1] 294341 0
Lifestyle
Intervention code [2] 294422 0
Treatment: Other
Comparator / control treatment
The control group will continue with their usual diet and will be provided with general healthy dietary guidelines according to the Greek Ministry of Health and Welfare (1999). At baseline and at 6 months during usual medical consultations children will be assessed using anthropometry, spirometry and exhaled Nitric Oxide analysis. Children together with parents will complete socio-demographic, Asthma Control Questionnaire, Paediatric Asthma Quality of life and food frequency questionnaires as well as biochemical tests. At both time-points, telephone-interviews will be conducted by the dietitian (lasting approximately 60 minutes) to collect medical, dietary and lifestyle information. Patients will be monitored fortnightly via telephone, text, e-mails, face-to-face consultations from the dietitian until the end of the study. At the end of 6 months, the child and their family will have a personalized consultation with the dietitian and will be provided with an information brochure on general healthy eating guidelines based on the Greek Mediterranean dietary guidelines (Greek Ministry of Health and Welfare, 1999) .
Control group
Active

Outcomes
Primary outcome [1] 297813 0
Respiratory function as assessed by spirometry (FEV1, FVC, FEV1/FVC, PEF, FEF 25-75%) and bronchial inflammation by exhaled Nitric Oxide (eNO) analysis.
Timepoint [1] 297813 0
Measured at baseline and 6 months
Primary outcome [2] 297814 0
Composite outcome of asthma status as indicated by the number of asthma episodes, day and night symptoms, need for reliever medication, hospitalization/medical care and by parent's report ( GINA, 2016)
Timepoint [2] 297814 0
Evaluated at baseline and 6 months
Secondary outcome [1] 322325 0
Asthma Control assessed by Asthma Control (ACQ) questionnaire
Timepoint [1] 322325 0
Measured at baseline and 6 months
Secondary outcome [2] 322328 0
Dietary habits evaluated using a Food Frequency Questionnaire
Timepoint [2] 322328 0
Assessed at baseline and at 6 months
Secondary outcome [3] 322329 0
Quality of life using the mini Paediatric Asthma Quality of Life Questionnaire(PAQLQ) (Juniper, 1996; 1999)
Timepoint [3] 322329 0
Measured at baseline and at 6 months
Secondary outcome [4] 322330 0
This is a composite secondary outcome. Change in plasma fatty acid composition, organic acids, Methyltetrahydrofolate, Vitamin D status assessed using Metabolomics ( urine and serum assay)
Timepoint [4] 322330 0
Measured at baseline and at 6 months
Secondary outcome [5] 342060 0
Adherence to Mediterranean dietary pattern assessed using KIDMED Index (Serra-Majem, 2003;2004)
Timepoint [5] 342060 0
baseline and 6 months

Eligibility
Key inclusion criteria
Asthma was defined as physician-diagnosed 'mild asthma.'
Minimum age
5 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Children suffering from cystic fibrosis, GERD, pneumonia, congenital respiratory disease, food allergies, requiring regular treatment with multiple glucocorticoids drugs or cortisone, taking high dose multi-vitamins or fish oil capsules, unwilling to modify diet or being vegetarian.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomization will be carried out by an independent private statistician and the participant's group allocation and number will be provided to the pediatric pneumologist and research dietitian on enrolment who will provide participants with the appropriate dietary instructions
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization will be conducted by an independent private statistitian using an online computerised random number generator
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The number of children enrolled was adequate to evaluate two-sided hypotheses regarding differences in FEV1 between groups. We used 90% power, effect size 0.4, alpha of 0.05 at a probability level of less than 0.05 gave a sample size of 52 children. Allowing for a 20% drop out rate gave a final sample size of 64 children.
Data analysis will be performed using SPSS. Continuous variables will be assessed for normality applying graphical methods, descriptive statistics, and Shapiro-Wilks test. Differences between groups will be assessed using t-test and ANOVA for variables found to be normally-distributed; Kruskal-Wallis and Mann-Whitney in the case of non-normality. And categorical variables using Chi square tests. P-value will be considered to be statistically significant at the 5% level

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/10/2016
Actual
11/11/2016
Date of last participant enrolment
Anticipated
30/06/2018
Actual
31/12/2016
Date of last data collection
Anticipated
Actual
31/08/2017
Sample size
Target
64
Accrual to date
Final
72
Recruitment outside Australia
Country [1] 7756 0
Greece
State/province [1] 7756 0
Attiki

Funding & Sponsors
Funding source category [1] 293232 0
University
Name [1] 293232 0
La Trobe University
Country [1] 293232 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
La Trobe University
Department of Rehabilitation, Nutrition and Sport
School of Allied Health
Bundoora, 3086
Victoria Australia
Country
Australia
Secondary sponsor category [1] 292035 0
None
Name [1] 292035 0
Address [1] 292035 0
Country [1] 292035 0
Other collaborator category [1] 278920 0
Individual
Name [1] 278920 0
Dr.Charis Katsardis
Address [1] 278920 0
Private Pediatric Respiratory Allergy Clinic
1 Pafou St
Marousi
Athens, 15125
Country [1] 278920 0
Greece
Other collaborator category [2] 279370 0
Individual
Name [2] 279370 0
Doctor Dimitris Tsoukalas
Address [2] 279370 0
Metabolomic Clinic
5 Koumbari Street
Kolonaki Square
Athens
Country [2] 279370 0
Greece

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294712 0
Latrobe University Ethics Committee
Ethics committee address [1] 294712 0
Ethics committee country [1] 294712 0
Australia
Date submitted for ethics approval [1] 294712 0
30/04/2016
Approval date [1] 294712 0
08/07/2016
Ethics approval number [1] 294712 0
HEC 16-035

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 64734 0
A/Prof Catherine Itsiopoulos
Address 64734 0
La Trobe University
Department of Rehabilitation, Nutrition and Sport
School of Allied Health
Bundoora, 3086
Victoria
Country 64734 0
Australia
Phone 64734 0
+61 3 94791721
Fax 64734 0
+ 61 3 94792552
Email 64734 0
C.Itsiopoulos@latrobe.edu.au
Contact person for public queries
Name 64735 0
Charis Katsardis
Address 64735 0
Private Pediatric Respiratory Allergy Clinic
1 Pafou St
Marousi
Athens, 15125
Country 64735 0
Greece
Phone 64735 0
+ 30-210-9322946
Fax 64735 0
Email 64735 0
katsardis@yahoo.gr
Contact person for scientific queries
Name 64736 0
Charis Katsardis
Address 64736 0
Private Pediatric Respiratory Allergy Clinic
1 Pafou Street
Marousi
Athens, 15125
Greece
Country 64736 0
Greece
Phone 64736 0
+30-210-9322946
Fax 64736 0
Email 64736 0
katsardis@yahoo.gr

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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