Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000341628
Ethics application status
Approved
Date submitted
6/09/2005
Date registered
9/09/2005
Date last updated
9/09/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
Efficacy of a micronutrient fortified seasoning powder on micronutrient status, health, and physical and cognitive development of North East Thai primary school children.
Scientific title
Randomized controlled trial of the efficacy of a seasoning powder fortified with iron, zinc, vitamin A, and iodine on biochemical indices, growth and body composition, morbidity, and cognitive function of primary school children from North East Thailand.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anemia and deficiencies of iron, zinc, vitamin A, and iodine 434 0
Condition category
Condition code
Blood 506 506 0 0
Anaemia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention: seasoning powder fortified with iron, zinc, vitamin A, and iodine was served with school lunches of instant noodles or rice and consumed on each school day (5 days/week) for 31 weeks.
Intervention code [1] 379 0
None
Comparator / control treatment
Control: unfortified seasoning powder served with school lunches of instant noodles or rice and consumed on each school day (5 days/week) for 31 weeks.
Control group
Active

Outcomes
Primary outcome [1] 577 0
Anemia defined as: Haemoglobin (Hb) < 115 g/L, males and females, 5 age (years) < 12; Hb < 120 g/L, males and females, age (years) ÿ³ 12.
Timepoint [1] 577 0
Measured at baseline and at the end of the 31 week trial.
Secondary outcome [1] 1232 0
Timepoint [1] 1232 0

Eligibility
Key inclusion criteria
1. Apparently healthy primary school children 2. Hemoglobin > 80 g/L 3. Parental approval to participate in all aspects of the study 4. Parental approval to not use vitamin and mineral supplements during the trial.
Minimum age
Not stated
Maximum age
14 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Children with evidence of recent acute or chronic illnessesChildren with hemoglobin < 80 g/L.

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)
All children were randomized to the intervention or control group at one time. A text file containing the names of the consented children, a school code, their sex, and age, were sent to the project statistician in New Zealand. The statistician had no involvement with the recruitment of the children. A random number was generated for each child using the statistical package STATA. Children within each stratum, defined by school, age (< 108 months, ³ 108 months) and sex, were sorted by random number. Children in the first half were assigned to receive intervention A, while those in the second half were assigned to intervention B.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The sequence was generated using the uniform() function in the statistical package STATA (StataCorp. 2001. Stata Statistical Software: Release 7.0. College Station, TX: Stata Corporation). Stratification was used, with the strata being school, age (< 108 months, ³ 108 months), and sex.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2002
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
500
Accrual to date
Final
Recruitment outside Australia
Country [1] 174 0
New Zealand
State/province [1] 174 0

Funding & Sponsors
Funding source category [1] 568 0
Charities/Societies/Foundations
Name [1] 568 0
Micronutrient Initiative Fund
Country [1] 568 0
Canada
Primary sponsor type
University
Name
Institute of Nutrition, Mahidol University, Thailand
Address
Country
Thailand
Secondary sponsor category [1] 460 0
University
Name [1] 460 0
University of Otago
Address [1] 460 0
Dunedin
New Zealand
Country [1] 460 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1591 0
Human Ethics Committees of Mahidol University and University of Otago
Ethics committee address [1] 1591 0
Ethics committee country [1] 1591 0
Thailand
Date submitted for ethics approval [1] 1591 0
Approval date [1] 1591 0
Ethics approval number [1] 1591 0

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

Contacts
Principal investigator
Name 36209 0
Address 36209 0
Country 36209 0
Phone 36209 0
Fax 36209 0
Email 36209 0
Contact person for public queries
Name 9568 0
Rosalind S Gibson
Address 9568 0
Professor of Human Nutrition
Department of Human Nutrition
University of Otago
Union Street
PO Box 56
Dunedin 9015
Country 9568 0
New Zealand
Phone 9568 0
+64 3 4797955 (Office)
Fax 9568 0
+64 3 4797958 (Office)
Email 9568 0
[email protected]
Contact person for scientific queries
Name 496 0
Rosalind S Gibson
Address 496 0
Professor of Human Nutrition
Department of Human Nutrition
University of Otago
Union Street
PO Box 56
Dunedin 9015
Country 496 0
New Zealand
Phone 496 0
+64 3 4797955 (Office)
Fax 496 0
+64 3 4797958 (Office)
Email 496 0
[email protected]

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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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Documents added automatically
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