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Trial registered on ANZCTR


Registration number
ACTRN12608000047392
Ethics application status
Approved
Date submitted
16/01/2008
Date registered
29/01/2008
Date last updated
22/05/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
Growth and nutritional status of infants fed formula based on goat milk or cow milk.
Scientific title
A randomised trial to compare growth rates and nutritional status of infants fed formula based on goat milk or cow milk
Secondary ID [1] 508 0
G1.071
Universal Trial Number (UTN)
Trial acronym
TIGGA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Infant nutrition 2699 0
Condition category
Condition code
Diet and Nutrition 2817 2817 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Goat milk infant formula as the sole source of nutrient from enrollment until at least 4 months of age, thereafter with other complementary food up to 12 months of age. The study infant formula will be supplied in cans with appropriate sized scoops to measure the quantity of powder required to make up each feed (12.65g of goat milk powder per 100 ml of formula). The volume and frequency of formula feeding will be specfied by the infants' primary care provider according to the standardised infant feeding guidelines.
Intervention code [1] 2434 0
Other interventions
Comparator / control treatment
1. Cow milk infant formula as the sole source of nutrient from enrollment until at least 4 months of age, thereafter with other complementary food up to 12 months of age. The cow milk infant formula will be supplied in cans with appropriate sized scoops to measure the quantity of powder required to make up each feed (12.65g of cow milk powder per 100 ml of formula). The volume and frequency of formula feeding will be specfied by the infants' primary care provider according to the standardised infant feeding guidelines
2. Breast milk as the sole source of nutrient from enrollment until at least 4 months of age, thereafter with other complementary food up to 12 months of age.
Control group
Active

Outcomes
Primary outcome [1] 3702 0
Growth including weight and length. Weight will be measured using electronic scales with baby weighing trays and an error of 5g. A Harpenden Neonatometer will be used for measuring the length of the infants.
Timepoint [1] 3702 0
at 1, 2, 3, 4, 6 and 12 months of age
Secondary outcome [1] 6301 0
Gastrointestinal tolerance will be assessed by maternal report of frequency and consistency of stool (using The Bristol Stool Form Scale).
Timepoint [1] 6301 0
at 1, 2, 3 and 4 months of age
Secondary outcome [2] 6302 0
Blood biochemistry will be measured by NATA accredited pathology laboratories
Timepoint [2] 6302 0
at 4 months of age

Eligibility
Key inclusion criteria
healthy term infants, birth weight >=2.5kg & <=4.75kg, mother is exclusively feeding an infant formula within 2 weeks of birth or plans to exclusively breastfeed for at least 4 months.
Minimum age
No limit
Maximum age
14 Days
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
severe congenital or metabolic disease likely to affect infant feeding or growth, multiple birth.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomisation by phone
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation. Stratified allocation by gender and study centre. the
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
A parallel breastfed reference group consisting of 100 infants of mothers who plan to exclusively breastfed for at least 4 months will be recruited. mother will be encouraged to continue exclusively breast feeding until 6 months.
Phase
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
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)

Funding & Sponsors
Funding source category [1] 2952 0
Commercial sector/Industry
Name [1] 2952 0
Dairy Goat Co-operative (NZ) Ltd
Address [1] 2952 0
18 Gallagher Drive, PO Box 1398,
Hamilton, 3240, NZ
Country [1] 2952 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Dairy Goat Co-operative (NZ) Ltd
Address
18 Gallagher Drive, PO Box 1398,
Hamilton, 3240, NZ
Country
New Zealand
Secondary sponsor category [1] 2666 0
Other
Name [1] 2666 0
Women's & Children's Health Research Institute
Address [1] 2666 0
72 King William Road
North Adelaide, SA 5006
Country [1] 2666 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4891 0
Children, Youth and Women's Health Service
Ethics committee address [1] 4891 0
72 King William Road
North Adelaide, SA 5006
Ethics committee country [1] 4891 0
Australia
Date submitted for ethics approval [1] 4891 0
Approval date [1] 4891 0
14/12/2007
Ethics approval number [1] 4891 0
1980/08/10
Ethics committee name [2] 4892 0
Flinders Clinical Research Ethics Committee
Ethics committee address [2] 4892 0
FMC, Level 2, Room 2A221
Bedford Park, SA 5042
Ethics committee country [2] 4892 0
Australia
Date submitted for ethics approval [2] 4892 0
Approval date [2] 4892 0
15/11/2007
Ethics approval number [2] 4892 0
25/07

Summary
Brief summary
This project will compare the growth rates and nutritional status of infants who are exclusively fed formulae either based on goat milk or cow milk. Growth will be assessed regularly (2 weeks, 1, 2, 3, 4, 6 and 12 months). Blood biochemical profile of infants, including plasma amino acids, will be assessed at 4 months. Formula tolerance and stool frequency will be assessed through to 4 months of age and stool microbiota will be assessed through to 2 months of age. A gold standard reference group of breastfed infants will also be included.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28283 0
Address 28283 0
Country 28283 0
Phone 28283 0
Fax 28283 0
Email 28283 0
Contact person for public queries
Name 11440 0
Dr Jo Zhou
Address 11440 0
Child Nutrition Research Centre
Women's & Children's Hospital,
72 King William Rd,
North Adelaide, SA 5006
Country 11440 0
Australia
Phone 11440 0
08 8303 4111
Fax 11440 0
08 8303 7135
Email 11440 0
jo.zhou@adelaide.edu.au
Contact person for scientific queries
Name 2368 0
A/Prof Maria Makrides
Address 2368 0
Women's & Children's Hospital,
72 King William Rd,
North Adelaide, SA 5006
Country 2368 0
Australia
Phone 2368 0
08 8161 6067
Fax 2368 0
08 8161 8228
Email 2368 0
maria.makrides@cywhs.sa.gov.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary