Child of Urban Poverty Iron Project (CUPIP) - A Pilot Study
Condition: Iron-deficiency; Iron Deficiency Anemia; Micronutrient Deficiency; Nutrient Deficiency; Stunting
MeSH terms: Anemia, Iron-Deficiency; Iron Deficiencies
Study type: Interventional

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.
    

Intervention name(s): Vitamin and Mineral Powder
Intervention type(s): Dietary Supplement
Intervention description(s): Vitamin and mineral nutritional supplement. Each packet is 1g of powder, to be taken with food.
Other intervention name(s): Multiple Micronutrient Powder
Intervention MeSH terms: Micronutrients
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Treatment group: receives baseline deworming medication and daily micronutrient supplementation for 4 months; Control group: receives baseline deworming medication only
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment