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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supplementation Group | Experimental | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin and Mineral Powder | Dietary Supplement | Vitamin and mineral nutritional supplement. Each packet is 1g of powder, to be taken with food. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in serum ferritin level between baseline and after 4 months mineral supplementation | Blood test for serum ferritin level will be done at enrollment (0 months) and again at end of study period, after 4 months of supplementation (or no supplementation for control group). | First blood test upon enrollment, at 0 months. Second blood test at 4 months |
| Change in reticulocyte hemoglobin level between baseline and after 4 months mineral supplementation | Blood test for RET-He level will be done at enrollment (0 months) and again at end of study period, after 4 months of supplementation (or no supplementation for control group). | First blood test upon enrollment, at 0 months. Second blood test at 4 months |
| Change in C-reactive protein level between baseline and after 4 months mineral supplementation | Blood test for C-reactive protein level will be done at enrollment (0 months) and again at end of study period, after 4 months of supplementation (or no supplementation for control group). | First blood test upon enrollment, at 0 months. Second blood test at 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in height (cm) | Height of child will be measured at baseline (0 months) and after 4 months mineral supplementation (or no supplementation for control group). | First height measurement upon enrollment at 0 months. Second height measurement at 6 months. |
| Change in weight (kg) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lucy Chai See Lum, MD | University Malaya, Faculty of Medic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Malaya Medical Center | Kuala Lumpur | Kuala Lumpur | 59100 | Malaysia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36360757 | Derived | Wang CC, Abdul Jalal MI, Song ZL, Teo YP, Tan CA, Heng KV, Low MSY, Anuar Zaini A, Lum LCS. 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. Int J Environ Res Public Health. 2022 Oct 25;19(21):13878. doi: 10.3390/ijerph192113878. |
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Not planning to share patient data.
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| ID | Term |
|---|---|
| D018798 | Anemia, Iron-Deficiency |
| D006130 | Growth Disorders |
| ID | Term |
|---|---|
| D000747 | Anemia, Hypochromic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D014815 | Vitamins |
| ID | Term |
|---|---|
| D018977 | Micronutrients |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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Treatment group: receives baseline deworming medication and daily micronutrient supplementation for 4 months; Control group: receives baseline deworming medication only
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|
Weight of child will be measured at baseline (0 months) and after 4 months mineral supplementation (or no supplementation for control group). |
| First weight measurement upon enrollment at 0 months. Second weight measurement at 4 months. |
| D000090463 |
| Iron Deficiencies |
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000078622 | Nutrients |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |