Clinical trial NCT03819530: Child of Urban Poverty Iron Project (CUPIP) - A Pilot Study
Official title: A Pilot Study of Micronutrient Supplementation for Child of Urban Poverty Iron Project in Selangor, Malaysia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Iron-deficiency
Iron Deficiency Anemia
Micronutrient Deficiency
Nutrient Deficiency
Stunting
Lead sponsor: University of Malaya
Sponsor class: OTHER
First posted: 2019-01-28
Enrollment: 45
Sex: ALL
Minimum age (years): 6
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Treatment group: receives baseline deworming medication and daily micronutrient supplementation for 4 months; Control group: receives baseline deworming medication only
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Children aged 6 months to 5 years living in PPR Lembah Subang

Exclusion Criteria:

* Ex-premature babies and children with congenital abnormalities resulting in gross impairment
* Children whose caregiver did not consent to participation

Primary outcomes:
measure: Change in serum ferritin level between baseline and after 4 months mineral supplementation
timeFrame: First blood test upon enrollment, at 0 months. Second blood test at 4 months
measure: Change in reticulocyte hemoglobin level between baseline and after 4 months mineral supplementation
timeFrame: First blood test upon enrollment, at 0 months. Second blood test at 4 months
measure: Change in C-reactive protein level between baseline and after 4 months mineral supplementation
timeFrame: First blood test upon enrollment, at 0 months. Second blood test at 4 months
Secondary outcomes:
measure: Change in height (cm)
timeFrame: First height measurement upon enrollment at 0 months. Second height measurement at 6 months.
measure: Change in weight (kg)
timeFrame: First weight measurement upon enrollment at 0 months. Second weight measurement at 4 months.
Other outcomes:
Locations:
city: Kuala Lumpur
country: Malaysia
facility: University of Malaya Medical Center
state: Wilayah Persekutuan Kuala Lumpur
Study officials:
affiliation: University Malaya, Faculty of Medic
name: Lucy Chai See Lum, MD
role: PRINCIPAL_INVESTIGATOR
References: