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Trial registered on ANZCTR


Registration number
ACTRN12611000659909
Ethics application status
Approved
Date submitted
27/06/2011
Date registered
28/06/2011
Date last updated
29/06/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Zinc supplementation trial before and after routine vitamin A supplementation program and their effects on illness in Indonesian preschool children
Scientific title
The effect of zinc supplementation and its interaction with vitamin A on child immune response and morbidity rate in Indonesian preschool children
Secondary ID [1] 262488 0
Nil
Universal Trial Number (UTN)
U1111-1122-3969
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Upper Respiratory Tract Infections 268178 0
diarrhea 268186 0
other infections 268188 0
Condition category
Condition code
Diet and Nutrition 268307 268307 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
10mg elemental zinc in syrup daily for 4 months, i.e. 2 months before routine vitamin A supplementation and 2 months after vitamin A supplementation. Vitamin A supplementation were given as a single dose capsule of 200.000 IU retinol
Intervention code [1] 266843 0
Prevention
Intervention code [2] 266853 0
Treatment: Other
Comparator / control treatment
placebo (sucrose syrup in identical taste and appearance to the supplements) were given daily for 4 months, i.e. 2 months before routine vitamin A supplementation (200.000IU retinol in capsule) and 2 months after vitamin A supplementation
Control group
Placebo

Outcomes
Primary outcome [1] 269049 0
Upper Respiratory Tract Infection morbidity, diarrhea and other infections (Number of episodes, percent of days ill and duration per episode). Information on symptoms such as cough, runny nose, fever, sore throat for Upper Respiratory Tract Infection were asked from the mothers, collected and observed by health workers who visited the children every third day. Physicians diagnosed the disease based on symptoms and visited the subjects if necessary.
Timepoint [1] 269049 0
During 2 months after zinc supplementation started and during 2 months after vitamin A supplementation
Secondary outcome [1] 276876 0
Immune responses: Ex vivo INF-gamma, serum IgG and salivary IgA levels
Timepoint [1] 276876 0
at 2months after zinc supplementation started and at 2 months after vitamin A supplementation
Secondary outcome [2] 276879 0
Vitamin A status: Serum retinol and Retinol Binding Protein levels
Timepoint [2] 276879 0
Baseline, at 2 months and at 4 months after zinc supplementation started

Eligibility
Key inclusion criteria
Age 2-5 years old
Live in the study area
Generally healthy
Minimum age
24 Months
Maximum age
59 Months
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Moved to other area
Consume supplements <75% of the total supplement days

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table from a statistic book
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
The parallel assignment was done for zinc supplementation and placebo. The assignment for vitamin A supplementation was before and after receiving single dose vitamin A from routine vitamin A supplementation program
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
6/06/2003
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
826
Accrual to date
Final
Recruitment outside Australia
Country [1] 3678 0
Indonesia
State/province [1] 3678 0
Central Java

Funding & Sponsors
Funding source category [1] 267314 0
Charities/Societies/Foundations
Name [1] 267314 0
Nestle Foundation
Country [1] 267314 0
Switzerland
Primary sponsor type
Individual
Name
Martha Irene Kartasurya
Address
Public Health Faculty
Diponegoro University
Jl. Prof. Sudarto, SH, Tembalang
Semarang
Country
Indonesia
Secondary sponsor category [1] 266376 0
Individual
Name [1] 266376 0
Geoffrey Marks
Address [1] 266376 0
School of Population Health
The University of Queensland
Herston Road
Herston, QLD 4006
Country [1] 266376 0
Australia
Secondary sponsor category [2] 266380 0
Individual
Name [2] 266380 0
Faruk Ahmed
Address [2] 266380 0
School of Population Health
The University of Queensland
Herston Road
Herston, QLD 4006
Country [2] 266380 0
Australia
Other collaborator category [1] 252077 0
Individual
Name [1] 252077 0
Hertanto Wahyu Subagio
Address [1] 252077 0
Medical Faculty
Diponegoro University
Jl. dr. Sutomo 16-18
Semarang
Country [1] 252077 0
Indonesia
Other collaborator category [2] 252079 0
Individual
Name [2] 252079 0
Muhammad Zen Rahfiludin
Address [2] 252079 0
Public Health Faculty
Diponegoro University
Jl. Prof. Sudarto, SH, Tembalang
Semarang
Country [2] 252079 0
Indonesia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269304 0
Medical Research Ethics Committee
The University of Queensland
Ethics committee address [1] 269304 0
Cumbrae Stewart Building
Research Road
Brisbane QLD 4072
Ethics committee country [1] 269304 0
Australia
Date submitted for ethics approval [1] 269304 0
Approval date [1] 269304 0
05/06/2003
Ethics approval number [1] 269304 0
2003000137
Ethics committee name [2] 269308 0
Committee of Ethical Medical Research Medical Faculty Diponegoro University/ Dr. Kariadi Hospital
Ethics committee address [2] 269308 0
Jl. dr. Sutomo 16-18
Semarang
Ethics committee country [2] 269308 0
Indonesia
Date submitted for ethics approval [2] 269308 0
Approval date [2] 269308 0
22/03/2003
Ethics approval number [2] 269308 0
04/EC/FK/RSDK/2003

Summary
Brief summary
This zinc supplementation study aimed to investigate the effect of zinc and vitamin A supplementation on immune responses and Upper Respiratory Tract Infections (URTI), diarrhea and other infections in Indonesian preschool children.
The study results showed that zinc supplementation in addition to vitamin A supplementation promoted elimination of vitamin A deficiency and reduced upper respiratory tract infection morbidity. Zinc supplementation increased ex vivo INF gamma production, but vitamin A supplementation had no measurable impact on general immune responses used in the study.
Trial website
Trial related presentations / publications
Submitted to publication on June 2011
Public notes

Contacts
Principal investigator
Name 32800 0
Address 32800 0
Country 32800 0
Phone 32800 0
Fax 32800 0
Email 32800 0
Contact person for public queries
Name 16047 0
Martha Irene Kartasurya
Address 16047 0
Public Health Faculty
Diponegoro University
Jl. Prof. Sudarto, SH, Tembalang
Semarang
Country 16047 0
Indonesia
Phone 16047 0
+6281326441641
Fax 16047 0
+62 24 8451894
Email 16047 0
[email protected]
Contact person for scientific queries
Name 6975 0
Geoffrey Marks
Address 6975 0
School of Population Health
The University of Queensland
Herston Road
Herston QLD 4006
Country 6975 0
Australia
Phone 6975 0
+61 7 3365 5402
Fax 6975 0
+61 7 3365 5442
Email 6975 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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.