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

NCT03819530 | Completed

• 1 other identifier: 20181056741
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Iron-deficiency; Iron Deficiency Anemia; Micronutrient Deficiency; Nutrient Deficiency; Stunting

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (2)

• Change in height (cm)

  First height measurement upon enrollment at 0 months. Second height measurement at 6 months.

• Change in weight (kg)

  First weight measurement upon enrollment at 0 months. Second weight measurement at 4 months.

Study Arms (2)

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.

Dietary Supplement: Vitamin and Mineral Powder

Control Group

NO INTERVENTION

Receives baseline deworming medication. Blood iron and anthropometric measurements taken at 0 and 4 months.

Interventions

Vitamin and Mineral Powder DIETARY_SUPPLEMENT

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

Also known as: Multiple Micronutrient Powder

Supplementation Group

Eligibility Criteria

• Age: 6 Months - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 6 months to 5 years living in PPR Lembah Subang

You may not qualify if:

• Ex-premature babies and children with congenital abnormalities resulting in gross impairment
• Children whose caregiver did not consent to participation

Sponsors & Collaborators

• University of Malaya: lead

Study Sites (1)

University of Malaya Medical Center

Kuala Lumpur, Kuala Lumpur, 59100, Malaysia

Location

Related Publications (1)

• 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.

  PMID: 36360757 DERIVED

MeSH Terms

Conditions

Anemia, Iron-Deficiency; Growth Disorders

Interventions

Vitamins

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Micronutrients; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Nutrients; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Lucy Chai See Lum, MD

  University Malaya, Faculty of Medic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Treatment group: receives baseline deworming medication and daily micronutrient supplementation for 4 months; Control group: receives baseline deworming medication only

Study Record Dates

• First Submitted: January 15, 2019
• First Posted: January 28, 2019
• Study Start: September 16, 2019
• Primary Completion: February 29, 2020
• Study Completion: March 15, 2020
• Last Updated: August 31, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)