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

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

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12616001245482

Enrollment

357

Registered

2016-09-06

Start date

2016-10-03

Completion date

2017-01-10

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

6 Years to 9 Years

Healthy volunteers

Yes

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

Outcome results