Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000734268
Ethics application status
Approved
Date submitted
19/08/2009
Date registered
25/08/2009
Date last updated
28/07/2024
Date data sharing statement initially provided
12/06/2019
Date results provided
12/06/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Melbourne Atopy Cohort Study (MACS): A Randomised controlled trial of a partially hydrolysed whey and a soy formula for the prevention of allergic disease.
Scientific title
In children with a family history of allergic disease does consumption of a partially hydrolysed whey or a soy formula at the cessation or partial cessation of breastfeeding, when compared to conventional cows’ milk formula reduce the incidence of allergic disease
Secondary ID [1] 283672 0
Nil known
Universal Trial Number (UTN)
Trial acronym
MACS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Allergic manifestations
Eczema
Asthma
Allergic rhinitis
Atopy 243548 0
Condition category
Condition code
Inflammatory and Immune System 239852 239852 0 0
Allergies
Diet and Nutrition 239863 239863 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1: Partially hydrolysed whey formula (Nan HA) given as required, at the cessation, or partial cessation of breastfeeding, up to 12 months of age. Administered orally after mixing 4.4g of powdered formula to every 30 ml of warm water.
Arm2: Soy formula (Prosobee) given as required, at the cessation, or partial cessation of breastfeeding, up to 12 months of age. Administered orally after mixing 4.4g of powdered formula to every 30 ml of warm water
Intervention code [1] 241154 0
Prevention
Comparator / control treatment
Conventional cows' milk formula (NAN) given as required, at the cessation, or partial cessation of breastfeeding, up to 12 months of age. Administered orally after mixing 4.3g of powdered formula to every 30 ml of warm water
Control group
Active

Outcomes
Primary outcome [1] 240618 0
Allergic manifestations (eczema, food reactions, urticaria) assessed by telephone interview of parent
Timepoint [1] 240618 0
up to 2 years age. Telephone interviews were undertaken 18 times during the first two years of life (every 4 weeks until 64 weeks, then at 78 and 104 weeks)
Secondary outcome [1] 257255 0
eczema (assessed by telephone interview of parent)
Timepoint [1] 257255 0
up to 2 years age. Telephone interviews were undertaken 18 times during the first two years of life (every 4 weeks until 64 weeks, then at 78 and 104 weeks)
Secondary outcome [2] 257256 0
atopy (positive skin prick test)
Timepoint [2] 257256 0
6, 12, and 24 months of age, and 12, 18 and 25 years
Secondary outcome [3] 257257 0
eczema assessed by questionnaire designed specifically for this study at all time points, and using the validated International Study of Asthma and Allergies in Childhood questions at the 12, 18 and 25 year follow-up.
Timepoint [3] 257257 0
5-7, 12, 18 and 25 years of age. A questionnaire was conducted when the child was six, seven, 12, 18 and 25 years of age, At 12 years and younger, questions were asked of parents. At 18 and 25 years, participants were asked directly. The quesionnaire asked if the participant had had any episodesof eczema in the previous 12 months.
Secondary outcome [4] 257258 0
asthma assessed by questionnaire designed specifically for this study at all time points, and using the validated International Study of Asthma and Allergies in Childhood questions at the 12, 18 and 25 year follow-up.
Timepoint [4] 257258 0
5-7, 12, 18 and 25 years of age. A questionnaire was conducted when the child was six, seven, 12, 18 and 25 years of age, At 12 years and younger, questions were asked of parents. At 18 and 25 years, participants were asked directly. The quesionnaire asked if the participant had had any episodesof asthma in the previous 12 months.
Secondary outcome [5] 257259 0
allergic rhinitis assessed by questionnaire designed specifically for this study at all time points and using the validated International Study of Asthma and Allergies in Childhood questions at the 12, 18 and 25 year follow-up.
Timepoint [5] 257259 0
5-7, 12, 18 and 25 years of age. A questionnaire was conducted when the child was six, seven, 12, 18 and 25 years of age, At 12 years and younger, questions were asked of parents. At 18 and 15 years, participants were asked directly. The quesionnaire asked if the participant had had any episodesof asthma in the previous 12 months.
Secondary outcome [6] 349315 0
Lung function as assessed by spirometry
Timepoint [6] 349315 0
12, 18 and 25 years

Eligibility
Key inclusion criteria
Family history of allergic disease (asthma, eczema, allergic rhinitis or severe food allergy)
Minimum age
0 Years
Maximum age
0 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Nil

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)
Mother-baby pairs were allocated to the next sequential number on the allocation list as they were enrolled in the study, and were assigned to the formula code allocated to that number. The tins of formula were labeled at an independent location with a code number. Neither the study staff or particpants knew which formula was assigned to each tin code number.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomisation table created by a computer program
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/01/1990
Actual
8/01/1990
Date of last participant enrolment
Anticipated
1/11/1994
Actual
15/07/1994
Date of last data collection
Anticipated
31/12/2030
Actual
Sample size
Target
620
Accrual to date
Final
620
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 237520 0
Commercial sector/Industry
Name [1] 237520 0
Nestec Ltd,
Country [1] 237520 0
Switzerland
Funding source category [2] 237521 0
Government body
Name [2] 237521 0
National Health and Medical Research Council (NHMRC)
Country [2] 237521 0
Australia
Funding source category [3] 237522 0
Charities/Societies/Foundations
Name [3] 237522 0
Victorian Asthma Foundation
Country [3] 237522 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Nestec Ltd,
Address
Avenue Nestle 55 CH - 180-0 Vevey
Country
Switzerland
Secondary sponsor category [1] 236998 0
None
Name [1] 236998 0
Address [1] 236998 0
Country [1] 236998 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 243653 0
Mercy Hospital Human Research Ethics Committee
Ethics committee address [1] 243653 0
Ethics committee country [1] 243653 0
Australia
Date submitted for ethics approval [1] 243653 0
Approval date [1] 243653 0
19/01/1989
Ethics approval number [1] 243653 0

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

Contacts
Principal investigator
Name 30071 0
Prof Shyamali Dharmage
Address 30071 0
Centre for Epidemiology and Biostatistics
Melbourne School of Population and Global Health
L3, 207 Bouverie Street
University of Melbourne VIC 3010
Country 30071 0
Australia
Phone 30071 0
+61 3 83440737
Fax 30071 0
Email 30071 0
[email protected]
Contact person for public queries
Name 13318 0
Dr David Hill
Address 13318 0
Senior Consultant Allergist
Murdoch Children's Research Institute
The Royal Children’s Hospital
Flemington Road Parkville Victoria 3052
Country 13318 0
Australia
Phone 13318 0
+61 3 8344 0878
Fax 13318 0
Email 13318 0
[email protected]
Contact person for scientific queries
Name 4246 0
Dr David Hill
Address 4246 0
Senior Consultant Allergist
Murdoch Children's Research Institute
The Royal Children’s Hospital
Flemington Road Parkville Victoria 3052
Country 4246 0
Australia
Phone 4246 0
+61 3 8344 0878
Fax 4246 0
Email 4246 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Consent for release of IPD has not been obtained


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
SourceTitleYear of PublicationDOI
Dimensions AINo reason to change the current guidelines on allergy prevention2011https://doi.org/10.1016/j.jaci.2011.08.038
EmbaseDo variants in GSTs modify the association between traffic air pollution and asthma in adolescence?.2016https://dx.doi.org/10.3390/ijms17040485
EmbaseThe effect of breastfeeding on lung function at 12 and 18 years: A prospective cohort study.2016https://dx.doi.org/10.1183/13993003.01598-2015
EmbaseEarly smoke exposure is associated with asthma and lung function deficits in adolescents.2017https://dx.doi.org/10.1080/02770903.2016.1253730
EmbaseInteraction of Glutathione S-Transferase M1, T1, and P1 Genes With Early Life Tobacco Smoke Exposure on Lung Function in Adolescents.2019https://dx.doi.org/10.1016/j.chest.2018.08.1079
EmbaseTransient childhood wheeze is associated with less atopy in adolescence.2020https://dx.doi.org/10.1111/pai.13304
N.B. These documents automatically identified may not have been verified by the study sponsor.