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Trial registered on ANZCTR


Registration number
ACTRN12616001245482
Ethics application status
Approved
Date submitted
30/08/2016
Date registered
6/09/2016
Date last updated
16/10/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Micronutrient supplementation for improving micronutrient status in underweight and overweight/obese primary school children
Scientific title
The effect of a multiple micronutrient supplement on the micronutrient status of underweight and overweight/obese primary school children in Vietnam – a randomised controlled trial
Secondary ID [1] 290038 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anaemia 300087 0
Micronutrient status of primary school children 300088 0
Underweight 300142 0
Overweight and obesity 300143 0
Condition category
Condition code
Blood 299974 299974 0 0
Anaemia
Diet and Nutrition 299975 299975 0 0
Other diet and nutrition disorders
Diet and Nutrition 300020 300020 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention: a multiple micronutrient supplement

Composition of each capsule: 12.5 mg iron, 10 mg zinc, 400 micrograms vitamin A, 0.5 mg vitamin B1, 0.5 mg vitamin B2, 0.5 mg vitamin B6, 0.9 microgram vitamin B12, 30 mg vitamin C, 5 micrograms vitamin D3, 5 mg vitamin E, 150 micrograms folic acid, 6 mg vitamin B3, 0.56 mg copper, 90 micrograms iodine and 17 micrograms selenium. One capsule will be consumed by each participant five times per week (Monday to Friday) for six months.

Adherence: school staff will administer the supplement (1 capsule) to each child every day (Monday to Friday) for six months. School staff will monitor and record if the supplement has been taken; both empty and unused blister packs will be collected from school staff to further assess adherence. A blood sample will be taken at the beginning and end of study to confirm the effectiveness of the supplement in increasing haemoglobin concentration, and improving iron, zinc, vitamin A and other micronutrient status.
Intervention code [1] 295790 0
Prevention
Comparator / control treatment
Placebo (placebo capsule) administered to each child five times per week (Monday to Friday) for six months. Adherence will be monitored as in the intervention group.
Control group
Placebo

Outcomes
Primary outcome [1] 299459 0
Haemoglobin concentration.
Timepoint [1] 299459 0
Measured at baseline and at 6 months after intervention commencement.
Primary outcome [2] 299461 0
Iron status (assessed by serum ferritin).
Timepoint [2] 299461 0
Measured at baseline and at 6 months after intervention commencement.
Primary outcome [3] 299505 0
Zinc status (assessed by serum zinc).
Timepoint [3] 299505 0
Measured at baseline and at 6 months after intervention commencement.
Secondary outcome [1] 327223 0
Primary outcome [4]: Vitamin A status (assessed by serum retinol).
Timepoint [1] 327223 0
Timepoint [4]: Measured at baseline and at 6 months after intervention commencement.
Secondary outcome [2] 327224 0
Primary outcome [5]: Vitamin D status (assessed by serum 25-hydroxyvitamin D).
Timepoint [2] 327224 0
Timepoint [5]: Measured at baseline and at 6 months after intervention commencement.
Secondary outcome [3] 327225 0
Primary outcome [6]: Selenium status (assessed via serum selenium).
Timepoint [3] 327225 0
Timepoint [6]: Measured at baseline and at 6 months after intervention commencement.
Secondary outcome [4] 327227 0
Primary outcome [7]: Serum/plasma concentrations of other micronutrients (composite outcome: serum copper, serum iron, serum folate).
Timepoint [4] 327227 0
Timepoint [7]: Measured at baseline and at 6 months after intervention commencement.
Secondary outcome [5] 327228 0
Growth (assessed by height, weight and z-scores).
Timepoint [5] 327228 0
Measured at baseline and at 6 months after intervention commencement.
Secondary outcome [6] 327358 0
Body composition (assessed by triceps skinfold thickness, mid-upper arm circumference and waist circumference).
Timepoint [6] 327358 0
Measured at baseline and at 6 months after intervention commencement.
Secondary outcome [7] 327359 0
Dietary intakes (assessed via a 24-h recall collected for 7 days at 4 time points).
Timepoint [7] 327359 0
Measured for 7 days at baseline, and at 1.5, 3, and 5 months after intervention commencement.
Secondary outcome [8] 327377 0
Morbidity and health status (assessed via daily health/illness records collected by school health staff, daily health/illness records collected by parents; school absence recorded by school staff; and C-reactive protein concentration measured at baseline and at 6 months.
Timepoint [8] 327377 0
Measured daily for 6 months.
Secondary outcome [9] 327378 0
Physical activity (assessed via a 24-h recall collected for 7 days at 4 time points).
Timepoint [9] 327378 0
Measured for 7 days at baseline, and at 1.5, 3, and 5 months after intervention commencement.
Secondary outcome [10] 327379 0
Cost-benefit analysis (analysis based on calculating total expenditure for the intervention and benefits gained from improvements in micronutrient status in the intervention group).
Timepoint [10] 327379 0
6 months after intervention commencement.
Secondary outcome [11] 339832 0
Cognitive function (assessed by a visual recall task)
Timepoint [11] 339832 0
Measured at baseline and at 6 months after intervention commencement.
Secondary outcome [12] 339833 0
Dietary pattern (assessed via a Food Frequency Questionnaire that assessed intakes over the previous 7 days).
Timepoint [12] 339833 0
Measured at baseline

Eligibility
Key inclusion criteria
Primary school children aged 6-9 years
Apparently healthy
Haemoglobin concentration <110 g/L
Minimum age
6 Years
Maximum age
9 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Haemoglobin concentration <70 g/L
Current/planned vitamin and mineral supplementation
Chronic disease
Chronic infection
Congenital abnormality
Severe malnutrition

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint(s)
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 outside Australia
Country [1] 8148 0
Viet Nam
State/province [1] 8148 0

Funding & Sponsors
Funding source category [1] 294412 0
Government body
Name [1] 294412 0
National Institute of Nutrition, Vietnam
Address [1] 294412 0
48B Tang Bat Ho Street
Hai Ba Trung District
Hanoi
Country [1] 294412 0
Viet Nam
Funding source category [2] 294413 0
University
Name [2] 294413 0
Deakin University
Address [2] 294413 0
221 Burwood Highway
Burwood VIC 3125
Country [2] 294413 0
Australia
Primary sponsor type
Individual
Name
Dr Ewa Szymlek-Gay
Address
Institute for Physical Activity and Nutrition (IPAN)
School of Exercise and Nutrition Sciences
Deakin University
221 Burwood Highway
Burwood VIC 3125
Country
Australia
Secondary sponsor category [1] 293261 0
Individual
Name [1] 293261 0
Dr Hoang Thi Duc Ngan
Address [1] 293261 0
National Institute of Nutrition
48B Tang Bat Ho Street
Hai Ba Trung District
Hanoi
Country [1] 293261 0
Viet Nam

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295831 0
Deakin University Human Research Ethics Committee (DUHREC)
Ethics committee address [1] 295831 0
221 Burwood Highway
Burwood VIC 3125
Ethics committee country [1] 295831 0
Australia
Date submitted for ethics approval [1] 295831 0
05/06/2016
Approval date [1] 295831 0
04/08/2016
Ethics approval number [1] 295831 0
2016-181
Ethics committee name [2] 295832 0
Ethics Committee of the National Institute of Nutrition
Ethics committee address [2] 295832 0
48B Tang Bat Ho Street
Hai Ba Trung District
Hanoi
Ethics committee country [2] 295832 0
Viet Nam
Date submitted for ethics approval [2] 295832 0
11/01/2016
Approval date [2] 295832 0
19/04/2016
Ethics approval number [2] 295832 0
610/VDD-QLKH; dated 30/9/2016

Summary
Brief summary
Micronutrient deficiencies are a major health problem among underweight children in Vietnam. Similarly, overweight/obese children are at an increased risk of micronutrient deficiencies. This is of concern because both underweight and overweight/obesity affect many school children in Vietnam. The aim of this study is to assess the effect of a multiple micronutrient supplement on the micronutrient status of underweight and overweight/obese primary school children in rural areas in Vietnam.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 68642 0
Dr Ewa Szymlek-Gay
Address 68642 0
Institute for Physical Activity and Nutrition (IPAN)
School of Exercise and Nutrition Sciences
221 Burwood Highway
Burwood VIC 3125
Country 68642 0
Australia
Phone 68642 0
+61 3 9244 5404
Fax 68642 0
Email 68642 0
ewa.szymlekgay@deakin.edu.au
Contact person for public queries
Name 68643 0
Dr Hoang Thi Duc Ngan
Address 68643 0
National Institute of Nutrition
48B Tang Bat Ho Street
Hai Ba Trung District
Hanoi
Country 68643 0
Viet Nam
Phone 68643 0
+84 43 9713088
Fax 68643 0
Email 68643 0
hoangthiducngan@dinhduong.org.vn
Contact person for scientific queries
Name 68644 0
Dr Ewa Szymlek-Gay
Address 68644 0
Institute for Physical Activity and Nutrition (IPAN)
School of Exercise and Nutrition Sciences
221 Burwood Highway
Burwood VIC 3125
Country 68644 0
Australia
Phone 68644 0
+61 3 9244 5404
Fax 68644 0
Email 68644 0
ewa.szymlekgay@deakin.edu.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