Micronutrient supplementation for improving micronutrient status in underweight and overweight/obese primary school children

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12616001245482
• Date of registration: 06/09/2016
• Prospective Registration: Yes
• Primary sponsor: Dr Ewa Szymlek-Gay
• 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
• Date of first enrolment: 03/10/2016
• Target sample size: 348
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12616001245482.aspx
• Study type: Interventional
• Study design: Purpose: Prevention; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy;

Countries of recruitment

Viet Nam

Contacts

• Name: Dr Hoang Thi Duc Ngan

• Name: Dr Ewa Szymlek-Gay

Key inclusion & exclusion criteria

Inclusion criteria: Primary school children aged 6-9 years
Apparently healthy
Haemoglobin concentration <110 g/L
Exclusion criteria: Haemoglobin concentration <70 g/L
Current/planned vitamin and mineral supplementation
Chronic disease
Chronic infection
Congenital abnormality
Severe malnutrition

Age minimum: 6 Years
Age maximum: 9 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Diet and Nutrition - Other diet and nutrition disorders

Diet and Nutrition - Obesity

Anaemia;Micronutrient status of primary school children;Underweight ;Overweight and obesity ;
Anaemia
Micronutrient status of primary school children
Underweight
Overweight and obesity

Blood - Anaemia

Intervention(s)

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.

Primary Outcome(s)

Haemoglobin concentration.[Measured at baseline and at 6 months after intervention commencement.]

Zinc status (assessed by serum zinc).[Measured at baseline and at 6 months after intervention commencement.]

Iron status (assessed by serum ferritin). [Measured at baseline and at 6 months after intervention commencement.]

Secondary Outcome(s)

Primary outcome [5]: Vitamin D status (assessed by serum 25-hydroxyvitamin D).[Timepoint [5]: Measured at baseline and at 6 months after intervention commencement.]

Body composition (assessed by triceps skinfold thickness, mid-upper arm circumference and waist circumference). [Measured at baseline and at 6 months after intervention commencement.]

Primary outcome [6]: Selenium status (assessed via serum selenium).[Timepoint [6]: Measured at baseline and at 6 months after intervention commencement.]

Dietary pattern (assessed via a Food Frequency Questionnaire that assessed intakes over the previous 7 days). [Measured at baseline ]

Physical activity (assessed via a 24-h recall collected for 7 days at 4 time points).[Measured for 7 days at baseline, and at 1.5, 3, and 5 months after intervention commencement.]

Primary outcome [7]: Serum/plasma concentrations of other micronutrients (composite outcome: serum copper, serum iron, serum folate). [Timepoint [7]: Measured at baseline and at 6 months after intervention commencement.]

Cognitive function (assessed by a visual recall task)[Measured at baseline and at 6 months after intervention commencement.]

Growth (assessed by height, weight and z-scores).[Measured at baseline and at 6 months after intervention commencement.]

Cost-benefit analysis (analysis based on calculating total expenditure for the intervention and benefits gained from improvements in micronutrient status in the intervention group). [6 months after intervention commencement.]

Dietary intakes (assessed via a 24-h recall collected for 7 days at 4 time points). [Measured for 7 days at baseline, and at 1.5, 3, and 5 months after intervention commencement.]

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.[Measured daily for 6 months. ]

Primary outcome [4]: Vitamin A status (assessed by serum retinol).[Timepoint [4]: Measured at baseline and at 6 months after intervention commencement.]

Secondary ID(s)

None

Source(s) of Monetary Support

Deakin University

National Institute of Nutrition, Vietnam

Secondary Sponsor(s)

Dr Hoang Thi Duc Ngan

Ethics review

Status: Approved
Approval date:
Contact:

Deakin University Human Research Ethics Committee (DUHREC)

Status: Approved
Approval date:
Contact:

Ethics Committee of the National Institute of Nutrition