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NCT Number: NCT03819530

Child of Urban Poverty Iron Project (CUPIP) - A Pilot Study

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.

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Key information

Conditions

Iron-deficiency Anemia Anemia, Hypochromic Anemia, Iron-Deficiency Growth Disorders Hematologic Diseases Hemic and Lymphatic Diseases Iron Deficiencies Iron Deficiency Anemia Iron Metabolism Disorders Metabolic Diseases Micronutrient Deficiency Nutrient Deficiency Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stunting

Age range

6 month–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Malaya Medical Center

Kuala Lumpur, 59100, Malaysia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin and Mineral Powder

Dietary Supplement

Vitamin and mineral nutritional supplement. Each packet is 1g of powder, to be taken with food.

Other names: Multiple Micronutrient Powder

Primary outcomes

  1. Change in serum ferritin level between baseline and after 4 months mineral supplementation

    Time frame: First blood test upon enrollment, at 0 months. Second blood test at 4 months

    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).

  2. Change in reticulocyte hemoglobin level between baseline and after 4 months mineral supplementation

    Time frame: First blood test upon enrollment, at 0 months. Second blood test at 4 months

    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).

  3. Change in C-reactive protein level between baseline and after 4 months mineral supplementation

    Time frame: First blood test upon enrollment, at 0 months. Second blood test at 4 months

    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).

Secondary outcomes

  1. Change in height (cm)

    Time frame: First height measurement upon enrollment at 0 months. Second height measurement at 6 months.

    Height of child will be measured at baseline (0 months) and after 4 months mineral supplementation (or no supplementation for control group).

  2. Change in weight (kg)

    Time frame: First weight measurement upon enrollment at 0 months. Second weight measurement at 4 months.

    Weight of child will be measured at baseline (0 months) and after 4 months mineral supplementation (or no supplementation for control group).

Sponsors and collaborators

Lead sponsor

University of Malaya

Other

Registry information

Official study title

A Pilot Study of Micronutrient Supplementation for Child of Urban Poverty Iron Project in Selangor, Malaysia

Acronym: CUPIP

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jan 28, 2019
Registry last updated
Aug 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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