Introducing cashew nuts during infancy – The Cashew Study.

• Register: ANZCTR
• Last refreshed on: 9 August 2022
• Main ID: ACTRN12618000228280
• Date of registration: 12/02/2018
• Prospective Registration: Yes
• Primary sponsor: Dr Debra Palmer
• 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.
• Date of first enrolment: 04/07/2018
• Target sample size: 192
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12618000228280.aspx
• Study type: Interventional
• Study design: Purpose: Prevention; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy;
• Phase: Not Applicable

Countries of recruitment

Australia

Contacts

• Name: Dr Debra Palmer

• Name: Dr Debra Palmer

Key inclusion & exclusion criteria

Inclusion criteria: Eligible participants will be infants who are born greater than or equal to 37 weeks gestation.
Exclusion criteria: Infants with a feeding difficulty that are unable to eat solid foods prior to 8 months of age.

Age minimum: 6 Months
Age maximum: 8 Months
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Inflammatory and Immune System - Allergies

Food allergy;Tree Nut Hypersensitivity;
Food allergy
Tree Nut Hypersensitivity

Intervention(s)

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.

Primary Outcome(s)

Cashew nut-specific IgG4 concentration in infant blood measured using the ImmunoCAP 250 system (Phadia AB, Uppsala, Sweden)..[At 1 year of age.]

Secondary Outcome(s)

Sensitization to cashew nut measured by cashew nut skin prick testing. [At 1 year of age.]

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.[At 1 year of age.]

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.[At 1 year of age.]

Medically diagnosed cashew nut allergy by a medical officer during the medically supervised cashew nut food challenge appointment at 1 year of age. [At 1 year of age.]

Sensitization to cashew nut measured by cashew nut-specific IgE concentration in infant blood measured using the ImmunoCAP 250 system (Phadia AB, Uppsala, Sweden).[At 1 year of age.]

Secondary ID(s)

none

Source(s) of Monetary Support

Australian Food Allergy Foundation

Ethics review

Status: Approved
Approval date: 12/01/2018
Contact:

Human Research Ethics Committee of the Joondalup Health Campus

Results

• Results available: Yes
• Date Posted: 05/08/2021
• Date Completed: 18/08/2021