Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT03819530 |
Other study ID # |
20181056741 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
September 16, 2019 |
Est. completion date |
March 15, 2020 |
Study information
Verified date |
August 2022 |
Source |
University of Malaya |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
The first 1,000 days of life are critical periods for brain development. Proper nutrition
lays the foundation for optimal growth, health, and neurodevelopment across the lifespan.
Poor nutrition in this vulnerable period has irreversible consequences, including stunting,
susceptibility to sickness, reduced school performance and productivity, and impaired
intellectual and social development. UNICEF reported in 2018 that among the low cost flat
residents in urban areas of the Klang Valley, 15% of children under 5 years old were stunted,
22% underweight, and 23% either overweight or obese.
Will a micronutrient supplementation program improve the growth and iron status of children
aged 6 months to 5 years staying in Lembah Subang? Children will be randomized into treatment
and control groups. Treatment groups will receive dietary micronutrient supplementation
packets. Measurements of height and weight and iron status will be taken at baseline and 4
months later.
Description:
This is a pilot study in a single-centre, using a single-blind, two-parallel group,
randomized trial conducted amongst children aged 6 months to 5 years residing at PPR Lembah
Subang, located in the state of Selangor, Malaysia between October 2019 and February 2020 (4
months). The participants were randomly assigned in a 3:2 treatment-to-control allocation to
receive, in addition to the baseline deworming treatment, either daily micronutrient packets
for 4 months (intervention arm) or no micronutrient supplementation (control group). This
residency area comprises a local population with mixed ethnic makeup and poor socioeconomic
status (majority are B40).
We distributed flyers, posters, and leaflets with the help of the community mothers in PPR
communities to encourage participation. Registration, informed consent and anthropometric
measurements, dietary logs and blood drawn for iron status were taken prior to randomization.
All children received a baseline deworming treatment at this point.
The treatment group received baseline deworming medications, a 4-month supply of daily
micronutrient supplementation and a compliance monitoring log. The control group only
received similar baseline deworming medications without any daily micronutrient
supplementation. Only the research investigators and outcome assessors were masked to the
treatment status whilst the participants and interventionists research investigators were
aware of the assigned intervention.
Primary endpoints assessed in this study are changes in serum ferritin and hemoglobin levels
at 0 and 4 months after interventions. The secondary endpoints are changes in age-and-sex
standardized height and weight percentile scores at 0 and 4 months after micronutrient
supplementation.