CUPIP: Child of Urban Poverty Iron Project

• Sponsor: University of Malaya (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03819530
• Collaborator: (none)
• Enrollment: 300
• Arms: 2
• Anticipated Duration (Months): 7

Study Details

Study Description

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 6 months later.

Condition or Disease	Intervention/Treatment	Phase
Iron-deficiency; Iron Deficiency Anemia; Micronutrient Deficiency; Nutrient Deficiency; Stunting	Dietary Supplement: Vitamin and Mineral Powder	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 300 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Treatment group: receives baseline deworming medication and daily micronutrient supplementation for 6 months; Control group: receives baseline deworming medication onlyTreatment group: receives baseline deworming medication and daily micronutrient supplementation for 6 months; Control group: receives baseline deworming medication only
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Micronutrient Supplementation for Child of Urban Poverty Iron Project in Selangor, Malaysia
• Anticipated Study Start Date: Feb 1, 2019
• Anticipated Primary Completion Date: Sep 1, 2019
• Anticipated Study Completion Date: Sep 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Supplementation Group Receives baseline deworming medication. Intervention: receive daily micronutrient supplementation packets- 6 month supply, to be taken every day. Blood iron and anthropometric measurements taken at 0 and 6 months.	Dietary Supplement: Vitamin and Mineral Powder; Vitamin and mineral nutritional supplement. Each packet is 1g of powder, to be taken with food.; Other Names: Multiple Micronutrient Powder
No Intervention: Control Group Receives baseline deworming medication. Blood iron and anthropometric measurements taken at 0 and 6 months.

Outcome Measures

Primary Outcome Measures

1. Change in serum ferritin level between baseline and after 6 months mineral supplementation [First blood test upon enrollment, at 0 months. Second blood test at 6 months]

   Blood test for serum ferritin level will be done at enrollment (0 months) and again at end of study period, after 6 months of supplementation (or no supplementation for control group).

2. Change in reticulocyte hemoglobin level between baseline and after 6 months mineral supplementation [First blood test upon enrollment, at 0 months. Second blood test at 6 months]

   Blood test for RET-He level will be done at enrollment (0 months) and again at end of study period, after 6 months of supplementation (or no supplementation for control group).

3. Change in C-reactive protein level between baseline and after 6 months mineral supplementation [First blood test upon enrollment, at 0 months. Second blood test at 6 months]

   Blood test for C-reactive protein level will be done at enrollment (0 months) and again at end of study period, after 6 months of supplementation (or no supplementation for control group).

Secondary Outcome Measures

1. Change in height (cm) [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 6 months mineral supplementation (or no supplementation for control group).

2. Change in weight (kg) [First weight measurement upon enrollment at 0 months. Second weight measurement at 6 months.]

   Weight of child will be measured at baseline (0 months) and after 6 months mineral supplementation (or no supplementation for control group).

3. Change in head circumference (cm) [First head circumference measurement upon enrollment at 0 months. Second head circumference measurement at 6 months.]

   Head circumference of child will be measured at baseline (0 months) and after 6 months mineral supplementation (or no supplementation for control group).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Months to 5 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• University of Malaya

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Malaya
• ClinicalTrials.gov Identifier: NCT03819530
• Other Study ID Numbers: 20181056741
• First Posted: Jan 28, 2019
• Last Update Posted: Jan 28, 2019
• Last Verified: Jan 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Anemia, Iron-Deficiency; Micronutrients

Study Results

No Results Posted as of Jan 28, 2019