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Randomized Controlled Trial
. 2022 Oct 25;19(21):13878.
doi: 10.3390/ijerph192113878.

A Randomized Pilot Trial of Micronutrient Supplementation for Under-5 Children in an Urban Low-Cost Flat Community in Malaysia: A Framework for Community-Based Research Integration

Crystal C Wang  1 , Muhammad Irfan Abdul Jalal  2 , Zhi Liang Song  3 , Yik Pheng Teo  3 , Chin Aun Tan  4 , Kai Voon Heng  5 , Michelle Siu Yee Low  3 , Azriyanti Anuar Zaini  3 , Lucy Chai See Lum  3
Affiliations
Randomized Controlled Trial

A Randomized Pilot Trial of Micronutrient Supplementation for Under-5 Children in an Urban Low-Cost Flat Community in Malaysia: A Framework for Community-Based Research Integration

Crystal C Wang et al. Int J Environ Res Public Health. .

Abstract

Early childhood nutritional deficiency has detrimental consequences on physical and cognitive development. We conducted a single-center, single-blind, two-arm pilot randomized no-treatment controlled trial (the Child of Urban Poverty Iron Project (CUPIP); NCT03819530) in a people’s housing project locale in Selangor, Malaysia, between September 2019 and February 2020, to assess the trial’s general feasibility and preliminary benefits of daily micronutrient supplementation for iron storage and anthropometric outcomes in under-5 children. Those with history of premature births, congenital abnormalities, or baseline hemoglobin <70 g/L were excluded. Participants received baseline deworming and were simply randomized in a 1:1 ratio to either micronutrient (4-month daily micronutrient packets) or control (no micronutrient supplementation) groups. Information on anthropometric, erythrocytic, and iron storage endpoints were collected. Overall, 45 (25 micronutrient and 20 controls) participants were enrolled and completed 4-month endpoint assessments. Micronutrient recipients demonstrated higher median mean corpuscular volume, serum ferritin level with no significant differences in all anthropometric endpoints. In conclusion, this pilot trial was implementable, demonstrating that micronutrient supplementation significantly improved hematological, but not anthropometric, endpoints, of under-5-year-old children living in an underprivileged environment. A definitive well-designed trial with larger sample sizes and greater attrition control should be contemplated in the future.

Keywords: Malaysia; child nutrition; intervention program; micronutrient supplementation program; pilot trial; stunting; urban poverty.

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Conflict of interest statement

The authors declared no conflict interest. The micronutrient supplier, DSM Nutritional Product, and the grant funder, Sysmex Asia Pacific, had no role in the design and conduct of the trial and analysis and interpretations of trial results.

Figures

Figure 1
Figure 1
The conceptual framework of the CUPIP trial.
Figure 2
Figure 2
The flow of the study from recruitment until the completion of all follow-up visits.
Figure 3
Figure 3
The CONSORT flow diagram of the study.
See this image and copyright information in PMC

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