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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12605000487617
Ethics application status
Approved
Date submitted
13/09/2005
Date registered
23/09/2005
Date last updated
23/09/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
Optimising micronutrient status in toddlers - putting the theory into practice
Scientific title
A food-based intervention to improve the micronutrient status of 12-24 month old New Zealand toddlers
Universal Trial Number (UTN)
Trial acronym
TFS (Toddler Food Study)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Micronutrient status of toddlers 609 0
Condition category
Condition code
Diet and Nutrition 681 681 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Children are randomised into one of three food-based intervention groups i.e., a meat-based, fortified milk or an unfortified milk group.
The intervention period is 20-weeks.
Intervention code [1] 572 0
Other interventions
Comparator / control treatment
Control group
Placebo

Outcomes
Primary outcome [1] 831 0
Biochemical assessments of the micronutrient status of the study participants
Timepoint [1] 831 0
Measured at baseline and at 20 weeks.
Secondary outcome [1] 1636 0
Growth
Timepoint [1] 1636 0
Measured at baseline and at 20 weeks
Secondary outcome [2] 1637 0
Body composition
Timepoint [2] 1637 0
Measured at baseline and at 20 weeks
Secondary outcome [3] 1638 0
Dietary intakes
Timepoint [3] 1638 0
Measured for 7 days in every 4 weeks.
Secondary outcome [4] 1639 0
Blood lipid levels (meat and unfortified milk groups only).
Timepoint [4] 1639 0
Measured at baseline and at 20 weeks
Secondary outcome [5] 1640 0
Health status
Timepoint [5] 1640 0
Measured daily for 20 weeks.

Eligibility
Key inclusion criteria
(a) Child aged 12-20 months at recruitment(b) Child apparently healthy.
Minimum age
12 Years
Maximum age
20 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(a) Child has iron deficiency anaemia and/or haemoglobin < 105 g/L at baseline(b) Child is currently consuming iron- or zinc-containing supplements(c) Child is being given Toddler milk or Infant formula(d) Child does not drink cow's milk or eat meat(e) Parent is unwilling to offer the child the study food.

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)
A computer programme randomly assigns each subject into a group using a randomised block format. Subjects are entered into the computer programme for randomisation in the order that they become eligible (i.e. in the order in which biochemical results are received from an independent laboratory). Neither study subjects nor researchers know whether assignment has been to the Fortified Milk or Unfortified Milk group. Both milk powders are packaged in unmarked cans that are indistinguishable from each other.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated random numbers
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
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 outside Australia
Country [1] 220 0
New Zealand
State/province [1] 220 0

Funding & Sponsors
Funding source category [1] 753 0
Government body
Name [1] 753 0
Health Research Council of New Zealand
Address [1] 753 0
Country [1] 753 0
New Zealand
Funding source category [2] 754 0
Commercial sector/Industry
Name [2] 754 0
Meat and Livestock Australia
Address [2] 754 0
Country [2] 754 0
Australia
Funding source category [3] 755 0
Charities/Societies/Foundations
Name [3] 755 0
Meat and Wool New Zealand
Address [3] 755 0
Country [3] 755 0
New Zealand
Funding source category [4] 756 0
University
Name [4] 756 0
University of Otago
Address [4] 756 0
Country [4] 756 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
Country
New Zealand
Secondary sponsor category [1] 624 0
None
Name [1] 624 0
nil
Address [1] 624 0
Country [1] 624 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1975 0
The University of Otago Ethics Committee
Ethics committee address [1] 1975 0
Ethics committee country [1] 1975 0
New Zealand
Date submitted for ethics approval [1] 1975 0
Approval date [1] 1975 0
Ethics approval number [1] 1975 0

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

Contacts
Principal investigator
Name 35479 0
Address 35479 0
Country 35479 0
Phone 35479 0
Fax 35479 0
Email 35479 0
Contact person for public queries
Name 9761 0
Ewa Szymlek-Gay
Address 9761 0
Department of Human Nutrition
University of Otago
PO Box 56
Dunedin 9031
Country 9761 0
New Zealand
Phone 9761 0
+64 3 4798369
Fax 9761 0
+64 3 4797958
Email 9761 0
szyew607@student.otago.ac.nz
Contact person for scientific queries
Name 689 0
Drs Elaine Ferguson and Anne-Louise Heath
Address 689 0
Department of Human Nutrition
University of Otago
PO Box 56
Dunedin 9031
Country 689 0
New Zealand
Phone 689 0
+64 3 4797959
Fax 689 0
+64 3 4797958
Email 689 0
elaine.ferguson@stonebow.otago.ac.nz OR anne-louise.heath@stonebow.otago.ac.nz

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