A Pilot Study of Micronutrient Supplementation for Child of Urban Poverty Iron Project in Selangor, Malaysia
| Registry | NCT03819530, acronym CUPIP |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: single, treatment |
| Enrollment | 45 (Actual) |
| Sponsor | University of Malaya (Other) |
| Conditions | Iron-deficiency, Iron Deficiency Anemia, Micronutrient Deficiency, Nutrient Deficiency, Stunting |
| Interventions | Vitamin and Mineral Powder (Dietary supplement) |
| Dates | start 2019-09-16, primary completion 2020-02-29, completion 2020-03-15, first posted 2019-01-28, last updated 2022-08-31 |
| Locations | 1 site in Malaysia |
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All trials for Iron-deficiency All trials for Iron Deficiency Anemia All trials of Vitamin and Mineral Powder
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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Supplementation Group | Experimental | Dietary Supplement: Vitamin and Mineral Powder | Receives baseline deworming medication. Intervention: receive daily micronutrient supplementation packets- 4 month supply, to be taken every day. Blood iron and anthropometric measurements taken at 0 and 4 months. |
| Control Group | No intervention | Receives baseline deworming medication. Blood iron and anthropometric measurements taken at 0 and 4 months. |
Sex: All, ages: 6 Months to 5 Years
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
| Facility | City | Country | Status |
|---|---|---|---|
| University of Malaya Medical Center | Kuala Lumpur, Kuala Lumpur | Malaysia |