Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000134527
Ethics application status
Approved
Date submitted
13/01/2024
Date registered
14/02/2024
Date last updated
4/08/2024
Date data sharing statement initially provided
14/02/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Eating nuts while breastfeeding – the Nuts For Babies Study.
Scientific title
Developing infant tolerance to nuts via breastmilk: a randomised controlled trial.
Secondary ID [1] 311318 0
Nil known
Universal Trial Number (UTN)
U1111-1302-6343
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
IgE-mediated peanut allergy 332569 0
IgE-mediated cashew nut allergy 332725 0
Condition category
Condition code
Inflammatory and Immune System 329267 329267 0 0
Allergies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Maternal consumption of at least 60 peanuts and 40 cashew nuts per week from birth until 6 months post-natal. Participants will purchase their own peanuts and cashew nuts. Every 2 weeks during the intervention period, the women will be sent a mobile phone text with a link to complete a quick survey about how much peanut and cashew nut they have eaten over the past week, and whether they would like any further advice and support regarding their allocated nut diet. This will also include one question on their breastfeeding status.
Intervention code [1] 327764 0
Prevention
Comparator / control treatment
Maternal consumption of no more than 20 peanuts and 12 cashew nuts per week from birth until 6 months post-natal. Participants will purchase their own peanuts and cashew nuts. Every 2 weeks during the intervention period, the women will be sent a mobile phone text with a link to complete a quick survey about how much peanut and cashew nut they have eaten over the past week, and whether they would like any further advice and support regarding their allocated nut diet. This will also include one question on their breastfeeding status.
Control group
Dose comparison

Outcomes
Primary outcome [1] 337089 0
The proportion of infants with IgE-mediated peanut and/or cashew nut allergy - this is a composite primary outcome.
Timepoint [1] 337089 0
At 12 months of age
Secondary outcome [1] 430637 0
The proportion of infants with IgE-mediated peanut allergy
Timepoint [1] 430637 0
At 12 months of age
Secondary outcome [2] 430638 0
The proportion of infants with IgE-mediated cashew nut allergy
Timepoint [2] 430638 0
At 12 months of age
Secondary outcome [3] 430639 0
The proportion of infants with allergic sensitisation to peanut
Timepoint [3] 430639 0
At 12 months of age
Secondary outcome [4] 430640 0
The proportion of infants with allergic sensitisation to cashew nut
Timepoint [4] 430640 0
At 12 months of age
Secondary outcome [5] 430641 0
The proportion of infants with allergic sensitisation to almond
Timepoint [5] 430641 0
At 12 months of age
Secondary outcome [6] 430642 0
The proportion of infants with allergic sensitisation to hazelnut
Timepoint [6] 430642 0
At 12 months of age
Secondary outcome [7] 430643 0
The proportion of infants with a medical diagnosis of eczema
Timepoint [7] 430643 0
At 3, 6, 9 and 12 months of age

Eligibility
Key inclusion criteria
Women with a singleton pregnancy, who are planning to breastfeed, and where the infant has a high-risk of developing nut allergies due to a family history of eczema/atopic dermatitis, IgE-mediated food allergy and/or hay fever (allergic rhinitis) in at least one of the infant’s biological parents (mother and/or father) or full-sibling (child with the same biological mother and father).
Minimum age
18 Years
Maximum age
50 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Women with a peanut and/or cashew nut allergy, as they would be unable to safely follow the intervention without an allergic reaction. Women who have already participated in the Nuts For Babies Study with a previous child.

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)
Central randomisation using a secure web-based randomisation service. The randomisation service will allocate a unique uninformative participant trial identification number and a group assignment according to a computer-generated randomisation schedule produced by a statistician not otherwise involved in the trial.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be stratified by any parental/sibling history of eczema/atopic dermatitis or IgE-mediated food allergy, using randomly permuted blocks of varying sizes.
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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
8/04/2024
Actual
22/07/2024
Date of last participant enrolment
Anticipated
30/06/2028
Actual
Date of last data collection
Anticipated
30/11/2029
Actual
Sample size
Target
742
Accrual to date
3
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 315569 0
Other
Name [1] 315569 0
Telethon Kids Institute
Country [1] 315569 0
Australia
Primary sponsor type
Other
Name
Telethon Kids Institute
Address
15 Hospital Ave Nedlands Western Australia 6009
Country
Australia
Secondary sponsor category [1] 317661 0
None
Name [1] 317661 0
Address [1] 317661 0
Country [1] 317661 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314468 0
Child and Adolescent Health Service, Western Australia
Ethics committee address [1] 314468 0
15 Hospital Ave Nedlands Western Australia 6009
Ethics committee country [1] 314468 0
Australia
Date submitted for ethics approval [1] 314468 0
19/01/2024
Approval date [1] 314468 0
22/02/2024
Ethics approval number [1] 314468 0

Summary
Brief summary
Australia has the highest prevalence of food allergy in the world, with at least one in every 32 (3.1%) infants developing peanut allergy and one in every 66 (1.5%) infants developing a cashew nut allergy, which are usually lifelong. Nut allergies place individuals and their families under enormous stress and have been shown to decrease quality of life.
This trial aims to determine if the risk of developing peanut and cashew nut allergy during infancy can be reduced by a maternal diet rich in peanuts and cashew nuts during breastfeeding. A finding from our recent Western Australian pilot randomised controlled trial (ACTRN12617001465347) with 109 mother-infant pairs discovered that a maternal high-peanut diet, compared to a low-peanut diet, during the first six months of lactation may reduce the risk that her infant will develop a peanut allergy.
We now propose a definitive efficacy randomised controlled trial, in order to provide high-quality evidence to inform maternal diet guidelines for peanut and cashew nut allergy prevention. If the hypothesis is correct, this will be a simple strategy to reduce nut allergies. If incorrect, this information will be paramount for informing breastfeeding women about food choices.
Participating mothers will be randomly allocated into either a high-nut (minimum of 60 peanuts and 40 cashew nuts per week), or a low-nut (maximum of 20 peanuts and 12 cashew nuts per week) group, for 6 months from the birth of their baby. From six months of age after commencement of solid foods, both groups will be encouraged to include smooth peanut butter and cashew nut spread in their baby’s diet as per our current Australian infant feeding and allergy prevention guidelines. Infant peanut and cashew nut allergy outcomes will be assessed at 12 months of age. This trial has been co-designed with consumers who will continue to be involved in all stages.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 131686 0
A/Prof Debra Palmer
Address 131686 0
Telethon Kids Institute, 15 Hospital Ave, Nedlands WA 6009
Country 131686 0
Australia
Phone 131686 0
+61 410851607
Fax 131686 0
Email 131686 0
[email protected]
Contact person for public queries
Name 131687 0
Debra Palmer
Address 131687 0
Telethon Kids Institute, 15 Hospital Ave, Nedlands WA 6009
Country 131687 0
Australia
Phone 131687 0
+61 410851607
Fax 131687 0
Email 131687 0
[email protected]
Contact person for scientific queries
Name 131688 0
Debra Palmer
Address 131688 0
Telethon Kids Institute, 15 Hospital Ave, Nedlands WA 6009
Country 131688 0
Australia
Phone 131688 0
+61 410851607
Fax 131688 0
Email 131688 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual (de-identified) participant data underlying published results only.
When will data be available (start and end dates)?
Beginning 6 months and ending 3 years following main results publication.
Available to whom?
Case-by-case basis at the discretion of the Chief Investigator Team and Primary Sponsor.
Available for what types of analyses?
For individual participant data meta-analyses.
How or where can data be obtained?
Access subject to approvals from Principal Investigator Debra Palmer
(email: [email protected])


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.