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Trial registered on ANZCTR


Registration number
ACTRN12618000228280
Ethics application status
Approved
Date submitted
2/02/2018
Date registered
12/02/2018
Date last updated
21/02/2020
Date data sharing statement initially provided
11/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Introducing cashew nuts during infancy – The Cashew Study.
Scientific title
Regular intake of cashew nut paste in infant diets between six to twelve months of age to reduce cashew nut allergy at 1 year of age - a dose response randomised controlled trial.
Secondary ID [1] 293952 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Food allergy 306454 0
Tree Nut Hypersensitivity 306486 0
Condition category
Condition code
Inflammatory and Immune System 305540 305540 0 0
Allergies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1: The families will be provided with the updated 2016 ASCIA infant feeding and allergy prevention guidelines (www.allergy.org.au). In addition, the families will be advised to orally give their infant 1 teaspoon of cashew nut spread (100% cashew nuts) mixed with their solid foods three times per week from 6-8 until 12 months of age . Families will be provided with jars of the cashew nut spread to use..
Arm 2: The families will be provided with the updated 2016 ASCIA infant feeding and allergy prevention guidelines. In addition, the families will be advised to orally give their infant increasing amounts of the cashew nut spread (100% cashew nuts) mixed with their solid foods three times per week. The increasing dosage regime will be 1 teaspoon from 6-7 months, 2 teaspoons from 8-9 months and 3 teaspoons from 10 months of age with the intervention period of from 6-8 until 12 months of age . If a participant commences at 8 months of age the starting dose will be 2 teaspoons. Families will be provided with jars of the cashew nut spread to use.

Compliance: All arm 1 and arm 2 participating families will be contacted monthly via a 10 minute telephone call and asked about how much of the Cashew Nut spread their infant had eaten over the preceding week.
Intervention code [1] 300218 0
Prevention
Comparator / control treatment
The families will be provided with the updated 2016 ASCIA infant feeding and allergy prevention guidelines..
Control group
Active

Outcomes
Primary outcome [1] 304674 0
Cashew nut-specific IgG4 concentration in infant blood measured using the ImmunoCAP 250 system (Phadia AB, Uppsala, Sweden)..
Timepoint [1] 304674 0
At 1 year of age.
Secondary outcome [1] 342734 0
Sensitization to cashew nut measured by cashew nut-specific IgE concentration in infant blood measured using the ImmunoCAP 250 system (Phadia AB, Uppsala, Sweden).
Timepoint [1] 342734 0
At 1 year of age.
Secondary outcome [2] 342735 0
Sensitization to cashew nut measured by cashew nut skin prick testing.
Timepoint [2] 342735 0
At 1 year of age.
Secondary outcome [3] 342736 0
Medically diagnosed cashew nut allergy by a medical officer during the medically supervised cashew nut food challenge appointment at 1 year of age.
Timepoint [3] 342736 0
At 1 year of age.
Secondary outcome [4] 342737 0
Medically diagnosed eczema between 6 to 12 months of age via parent self-report or via examination by a medical officer during the 1 year of age appointment.
Timepoint [4] 342737 0
At 1 year of age.
Secondary outcome [5] 342738 0
Medically diagnosed wheeze between 6 to 12 months of age via parent self-report or via examination by a medical officer during the 1 year of age appointment.
Timepoint [5] 342738 0
At 1 year of age.

Eligibility
Key inclusion criteria
Eligible participants will be infants who are born greater than or equal to 37 weeks gestation.
Minimum age
6 Months
Maximum age
8 Months
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Infants with a feeding difficulty that are unable to eat solid foods prior to 8 months of age.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation was concealed by use of sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Analysis Plan: For the primary and secondary outcome measurements with detection thresholds (cashew nut-specific IgG4 and IgE concentrations) Tobit regression models will be used, with treatment effects described using ratios of means and 95% confidence intervals. The secondary binary outcomes food allergy, food sensitisation, eczema and wheeze will be analysed using log binomial regression models, with treatment effects described using relative risks and 95% confidence intervals.

Sample size calculations: The primary outcome for this study will be the difference in median cashew nut-specific IgG4 concentrations between the intervention group 1 and the control group. Using results from our previous egg introduction in infancy trial, the effect of the intervention of regular egg introduction versus egg avoidance on egg-specific IgG4 concentrations, for 80% power and 95% confidence (alpha-value 0.05), we would require 30 infants per group. As we require successful blood collections at 1 year of age for this primary outcome result, and our infant blood collection rate has been 60%, along with an expected completion rate of at least 80%, we would need to randomise 64 infants into each group. Thus our total sample size will be 3 groups of 64 infants = 192 infants.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 11535 0
Joondalup Health Campus - Joondalup
Recruitment postcode(s) [1] 23562 0
6027 - Joondalup

Funding & Sponsors
Funding source category [1] 298581 0
Charities/Societies/Foundations
Name [1] 298581 0
Australian Food Allergy Foundation
Address [1] 298581 0
PO Box 1242, Windsor, Victoria, 3181
Country [1] 298581 0
Australia
Primary sponsor type
Individual
Name
Dr Debra Palmer
Address
Telethon Kids Institute
Roberts Rd Subiaco WA 6008
Country
Australia
Secondary sponsor category [1] 297735 0
None
Name [1] 297735 0
Address [1] 297735 0
Country [1] 297735 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299546 0
Human Research Ethics Committee of the Joondalup Health Campus
Ethics committee address [1] 299546 0
PO Box 242, Joondalup WA 6919
Ethics committee country [1] 299546 0
Australia
Date submitted for ethics approval [1] 299546 0
19/11/2017
Approval date [1] 299546 0
12/01/2018
Ethics approval number [1] 299546 0
1740

Summary
Brief summary
In Australia cashew nut allergy is the most common of the tree nut allergies in adolescents. The 2016 revised Australasian Society of Clinical Immunology and Allergy (ASCIA) infant feeding and allergy prevention guidelines recommend: all infants should be given allergenic foods including peanut butter, cooked egg, dairy and wheat in the first year of life. However there is no specific mention of tree nut foods, like cashew nut spread. This is because we still need to establish evidence of the effect of regularly eating tree nuts or tree nut spreads in early childhood as a tree nut allergy prevention strategy. Cashew nut spreads are now readily available in supermarkets. With the texture of a paste like peanut butter, they could feasibly be introduced into the diets of infants once they have established the developmental readiness for eating solid foods. We propose to investigate two different doses of cashew nut spread regularly eaten by infants from 6 months of age onwards. This study will enable us to examine whether babies regularly eating cashew nut spread should be further investigated as a cashew nut allergy prevention strategy in a larger multi-centre randomised controlled trial. This evidence will contribute towards providing specific recommendations to also include tree nut spreads introduction during infancy in allergy prevention guidelines.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 80802 0
Dr Debra Palmer
Address 80802 0
Level 7, Telethon Kids Institute, Perth Children's Hospital, 15 Hospital Ave Nedlands WA 6009
Country 80802 0
Australia
Phone 80802 0
+61 410 851 607
Fax 80802 0
Email 80802 0
debbie.palmer@telethonkids.org.au
Contact person for public queries
Name 80803 0
Dr Debra Palmer
Address 80803 0
Level 7, Telethon Kids Institute, Perth Children's Hospital, 15 Hospital Ave Nedlands WA 6009
Country 80803 0
Australia
Phone 80803 0
+61 410 85 1607
Fax 80803 0
Email 80803 0
debbie.palmer@telethonkids.org.au
Contact person for scientific queries
Name 80804 0
Dr Debra Palmer
Address 80804 0
Level 7, Telethon Kids Institute, Perth Children's Hospital, 15 Hospital Ave Nedlands WA 6009
Country 80804 0
Australia
Phone 80804 0
+61 410 851 607
Fax 80804 0
Email 80804 0
debbie.palmer@telethonkids.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
After de-identification, individual participant data underlying published results only.
When will data be available (start and end dates)?
Beginning 6 months after and ending 5 years following main results publication
Available to whom?
Case by case basis at the discretion of CI Debbie Palmer
Available for what types of analyses?
For IPD meta-analyses
How or where can data be obtained?
Access subject to approvals by CI Debbie Palmer
What supporting documents are/will be available?
No other documents available
Summary results
No Results