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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]

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

IgE-mediated cashew nut allergy

Condition category

Condition code

Inflammatory and Immune System

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]

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]

The proportion of infants with IgE-mediated peanut and/or cashew nut allergy - this is a composite primary outcome.

Timepoint [1]

At 12 months of age

Secondary outcome [1]

The proportion of infants with IgE-mediated peanut allergy

Timepoint [1]

At 12 months of age

Secondary outcome [2]

The proportion of infants with IgE-mediated cashew nut allergy

Timepoint [2]

At 12 months of age

Secondary outcome [3]

The proportion of infants with allergic sensitisation to peanut

Timepoint [3]

At 12 months of age

Secondary outcome [4]

The proportion of infants with allergic sensitisation to cashew nut

Timepoint [4]

At 12 months of age

Secondary outcome [5]

The proportion of infants with allergic sensitisation to almond

Timepoint [5]

At 12 months of age

Secondary outcome [6]

The proportion of infants with allergic sensitisation to hazelnut

Timepoint [6]

At 12 months of age

Secondary outcome [7]

The proportion of infants with a medical diagnosis of eczema

Timepoint [7]

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?

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

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Other

Name [1]

Telethon Kids Institute

Address [1]

15 Hospital Ave Nedlands Western Australia 6009

Country [1]

Australia

Primary sponsor type

Other

Name

Telethon Kids Institute

Address

15 Hospital Ave Nedlands Western Australia 6009

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Child and Adolescent Health Service, Western Australia

Ethics committee address [1]

15 Hospital Ave Nedlands Western Australia 6009

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

19/01/2024

Approval date [1]

22/02/2024

Ethics approval number [1]

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

A/Prof Debra Palmer

Address

Telethon Kids Institute, 15 Hospital Ave, Nedlands WA 6009

Country

Australia

Phone

+61 410851607

Fax

[email protected]

Contact person for public queries

Name

Debra Palmer

Address

Telethon Kids Institute, 15 Hospital Ave, Nedlands WA 6009

Country

Australia

Phone

+61 410851607

Fax

[email protected]

Contact person for scientific queries

Name

Debra Palmer

Address

Telethon Kids Institute, 15 Hospital Ave, Nedlands WA 6009

Country

Australia

Phone

+61 410851607

Fax

[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

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No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

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