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Trial registered on ANZCTR


Registration number
ACTRN12610000646044
Ethics application status
Approved
Date submitted
13/06/2010
Date registered
9/08/2010
Date last updated
15/02/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Fortifying day-care meals with desiccated beef liver or micronutrient sprinkles to combat anaemia and micronutrient deficiencies in Brazillian pre-school children
Scientific title
In Brazillian pre-school children, do desiccated beef liver or micronutrient sprinkles improve micronutrient status relative to placebo as measured by haemoglobin changes
Secondary ID [1] 251855 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anaemia 257450 0
Micronutrient deficiencies 257451 0
Impaired growth 257452 0
Susceptibility to diarrhoea 257453 0
Susceptibility to repiratory infections 257454 0
Delayed motor development 257455 0
Impaired cognitive development 257456 0
Condition category
Condition code
Blood 257600 257600 0 0
Anaemia
Diet and Nutrition 257601 257601 0 0
Other diet and nutrition disorders
Public Health 257602 257602 0 0
Epidemiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1. Desiccated New Zealand beef liver (freeze dried cooked) from an 11g sachet to be added to mid-day day-care meals each weekday and to home-prepared meals once per day on holidays for 12 months.

Arm 2. Multi-micronutrient sprinkles (1g sprinkles plus 10g of maltodextrin per sachet) to be added to mid-day day-care meals each weekday and to home-prepared meals once per day on holidays for 12 months.
Multi-micronutrient sprinkles contain iron, zinc, selenium, vitamin C, vitamin D, thiamine, riboflavin, niacin, vitamin B6, folate, vitamin B12, copper and iodine.
Intervention code [1] 256546 0
Prevention
Comparator / control treatment
Beef flavoured and coloured maltodextrin from 11g sachet to be added to mid-day day-care meals each weekday and to home-prepared meals once per day on holidays for 12 months.
Control group
Placebo

Outcomes
Primary outcome [1] 258516 0
Differences in the changes in hemoglobin concentration to be measured electronically on an automated counter.
Timepoint [1] 258516 0
Baseline and at end of 12-month intervention.
Secondary outcome [1] 264319 0
Differences in the changes in serum ferritin determined using a microparticle enzyme immunoassay ferritin kit
Timepoint [1] 264319 0
Baseline and at end of 12-month intervention.
Secondary outcome [2] 264320 0
Differences in the changes in serum zinc by atomic absorption spectrophotometry
Timepoint [2] 264320 0
Baseline and at end of 12-month intervention.
Secondary outcome [3] 264321 0
Differences in the changes in serum selenium by atomic absorption spectrophotometry
Timepoint [3] 264321 0
Baseline and at end of 12-month intervention.
Secondary outcome [4] 264322 0
Differences in the changes in serum folate by microbiological assay
Timepoint [4] 264322 0
Baseline and at end of 12-month intervention.
Secondary outcome [5] 264323 0
Differences in the changes in serum retinol by high-performance liquid chromatography
Timepoint [5] 264323 0
Baseline and at end of 12-month intervention.
Secondary outcome [6] 264324 0
Differences in the incidence rate and average duration (in days) of respiratory-related illnesses, recorded on weekdays by day-care staff and at weekends & holidays by parental recall
Timepoint [6] 264324 0
Daily, throughout the 12-month intervention.
Secondary outcome [7] 264325 0
Differences in the incidence rate and average duration (in days) of diarrhoeal-related illnesses, recorded on weekdays by day-care staff and at weekends & holidays by parental recall
Timepoint [7] 264325 0
Daily, throughout the 12-month intervention.
Secondary outcome [8] 264327 0
Differences in the change in height for age Z-score
Timepoint [8] 264327 0
Baseline and at end of 12-month intervention.
Secondary outcome [9] 264328 0
Differences in the change in weight for age Z-score
Timepoint [9] 264328 0
Baseline and at end of 12-month intervention.
Secondary outcome [10] 264329 0
Differences in the change in weight for length Z-score
Timepoint [10] 264329 0
Baseline and at end of 12-month intervention.
Secondary outcome [11] 264330 0
Differences in the change in mean development score based on the Denver II Developmental Screening Test adapted to Brazilian Portuguese.
Timepoint [11] 264330 0
Baseline and at end of 12-month intervention.
Secondary outcome [12] 264331 0
Differences in the mean cognitive scores based on the Wechsler Pre-School and Primary scale of intelligence Revised (WPPSI-RI) at 12month follow-up only.
Timepoint [12] 264331 0
At end of 12-month intervention.

Eligibility
Key inclusion criteria
Preschool children aged 36 to 60 months whose parent expect to reside in Salvador for at least the subsequent 14 months
Minimum age
36 Months
Maximum age
60 Months
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Preschool children who have evidence of chronic disease

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)
Allocation will involve contacting the holder of the allocation schedule who will be "off-site" in New zealand
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratification will be by gender and age-group (36 to <48 mo; and 48 to 60 mo). Sequence generation will be performed by permuted block randomisation.
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
Withdrawn
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
1/08/2010
Actual
1/08/2010
Date of last participant enrolment
Anticipated
Actual
1/08/2010
Date of last data collection
Anticipated
Actual
Sample size
Target
500
Accrual to date
Final
1
Recruitment outside Australia
Country [1] 2656 0
Brazil
State/province [1] 2656 0
Bahia

Funding & Sponsors
Funding source category [1] 257047 0
University
Name [1] 257047 0
University of Otago
Country [1] 257047 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
Union St.,
PO Box 56,
Dunedin 9015
Country
New Zealand
Secondary sponsor category [1] 256305 0
Commercial sector/Industry
Name [1] 256305 0
Interstate Batteries
Address [1] 256305 0
12770 Merit Drive Suite 1000
Dallas, TX 75251
Country [1] 256305 0
United States of America
Secondary sponsor category [2] 256308 0
Individual
Name [2] 256308 0
Dr. Hugo da Costa Ribeiro Jr MD, PhD,
Address [2] 256308 0
Universidade Federal da Bahia,
Rua Dr. Augusto Viana,
s/n Canela, CEP: 40110-060
Salvador, Bahia,
Country [2] 256308 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259086 0
Ethics Review Board of the Federal University of Bahia
Ethics committee address [1] 259086 0
Ethics committee country [1] 259086 0
Brazil
Date submitted for ethics approval [1] 259086 0
Approval date [1] 259086 0
31/08/2009
Ethics approval number [1] 259086 0

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

Contacts
Principal investigator
Name 31215 0
Prof Rosalind S Gibson
Address 31215 0
Dept of Human Nutrition, University of Otago, PO Box 56, Union Street, Dunedin 9015
Country 31215 0
New Zealand
Phone 31215 0
+64 3 4797955
Fax 31215 0
Email 31215 0
[email protected]
Contact person for public queries
Name 14462 0
Prof. Hugo Ribeiro
Address 14462 0
Universidade Federal da BahiaCCC
Rua Padre Feijo,
29 – Canela
40-110-170- Salvador-Bahia
BRASIL
Country 14462 0
Brazil
Phone 14462 0
+55-71-328-38100
Fax 14462 0
Email 14462 0
[email protected]
Contact person for scientific queries
Name 5390 0
Prof. Rosalind Gibson
Address 5390 0
Dept of Human Nutrition,
University of Otago,
PO Box 56,
Union Street,
Dunedin
9015
Country 5390 0
New Zealand
Phone 5390 0
+64-3-479-7955
Fax 5390 0
Email 5390 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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