Daily and Weekly Iron Supplementation in Infants

Efficacy of Daily and Weekly Iron Supplementation on Anemia Prevalence in Thai Infants Aged 6-12 Months

This study aims to compare the efficacy of daily iron supplementation and weekly iron supplementation in infants aged 6-12 months on the prevalence of anemia, hemoglobin level, and serum ferritin levels. Infants will be enrolled at 6 months and will be randomly assigned to receive either daily or weekly iron supplementation for the first 3 months and will be followed by weekly iron supplementation for another 3 months.

Study Overview

• Status: Completed
• Conditions: Anemia; Iron; Infants; Iron Status
• Intervention / Treatment: Dietary supplement: Iron supplement

Detailed Description

This study aims to compare the efficacy of daily iron supplementation and weekly iron supplementation in infants aged 6-12 months on the prevalence of anemia, hemoglobin level, and serum ferritin levels. Normal birth weight and term infants will be enrolled at 6 months based on the inclusion criteria. Eligible participants will be assessed at baseline, including anthropometry, dietary intake, and biochemistry (hemoglobin, iron status, vitamin A status, and inflammation). Participants will then be randomly assigned to receive either daily or weekly iron supplementation for the first 3 months. Participants will be followed up at 9 months for the same assessments and will receive weekly iron supplementation for another 3 months. Participants will be followed up at 12 months and the same assessments will be performed. After that, participants will go back to the routine health care service, weekly iron supplementation.

• Study Type: Interventional
• Enrollment (Actual): 287
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Changwat Nakhon Pathom
    • Sam Phran, Changwat Nakhon Pathom, Thailand, 73110
      • Samphran District Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Apparently healthy infant, aged 6 months ± 2 weeks
• Having a birth weight between 2,500 and 4,000 grams
• Being born full term (37 to 41 weeks of age + 6 days)
• Having hemoglobin ≥ 10.5 g/dL
• Being planned to breastfeed with complementary food and/or complementary foods with formula milk

Exclusion Criteria:

• Infants with chronic illnesses or thalassemia clinical signs such as anemia, enlarged liver, or spleen (if parental history suggests the child is at risk of developing a thalassemia disease that may not show clinical symptoms)
• Previously or currently taking an iron supplement

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1 daily iron supplementation; 12.5 mg daily iron syrup supplementation from 6-9 months old, followed by 12.5 mg weekly iron syrup supplementation from 9-12 months old. Infants aged 6-9 months will receive two iron syrup bottles. One bottle aims for ingestion every Monday of the week, and one bottle aims for ingestion on other days of the week. At ages 9-12 months, infants will receive an iron syrup bottle that aims for ingestion every Monday of the week.	Dietary supplement: Iron supplement; Group 1: 12.5 mg daily iron syrup supplementation from 6-9 months old
Other: Group 2 weekly iron supplementation; 12.5 mg weekly iron syrup supplementation from 6-12 months old. Infants aged 6-9 months will receive an iron syrup bottle that aims for ingestion every Monday of the week and a placebo bottle that aims for ingestion on other days of the week. At ages 9-12 months, infants will receive an iron syrup bottle that aims for ingestion every Monday of the week.	Dietary supplement: Iron supplement; Group 1: 12.5 mg daily iron syrup supplementation from 6-9 months old

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anemia status	Hemoglobin concentration will be assessed and classified as anemia or non-anemia.	at aged 6, 9, and 12 months
Iron status	Serum ferritin will be assessed to reflect iron status	at aged 6, 9, and 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight	Body weight will be assessed, and weight-for-age and weight-for-length Z scores will be generated	at aged 6, 9, and 12 months
Length	Length will be assessed, and length-for-age Z scores and weight-for-length will be generated	at aged 6, 9, and 12 months
Dietary intake	Dietary intake will be assessed using the 24-hr dietary recall for 3 days	at aged 6, 9, and 12 months
Head circumference (HC)	HC will be assessed, and head circumference-for-age Z scores will be generated	at aged 6, 9, and 12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemoglobin typing	Hemoglobin typing will be assessed	at aged 12 months
C-reactive protein (CRP)	High sensitivity CRP will be analyzed and will be used for the adjustment of serum ferritin	at aged 6, 9, and 12 months
Alpha-1 acid glycoprotein (AGP)	AGP will be analyzed and will be used for the adjustment of serum ferritin	at aged 6, 9, and 12 months
Serum transferrin receptor	Serum transferrin receptor will be assessed to reflect iron status	at aged 6, 9, and 12 months
Serum Retinol Binding Protein (RBP)	RBP will be assessed to reflect vitamin A status	at aged 6, 9, and 12 months

Collaborators and Investigators

• Sponsor: Mahidol University
• Collaborators: Suranaree University of Technology
• Investigators: Principal Investigator: Tippawan Pongcharoen, PhD, Mahidol University

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2023
• Primary Completion (Actual): October 25, 2024
• Study Completion (Actual): May 14, 2025

Study Registration Dates

• First Submitted: March 13, 2024
• First Submitted That Met QC Criteria: March 13, 2024
• First Posted (Actual): March 19, 2024

Study Record Updates

• Last Update Posted (Actual): June 1, 2026
• Last Update Submitted That Met QC Criteria: May 28, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Anemia; Iron supplementation; Infants; Iron status
• Additional Relevant MeSH Terms: Hematologic Diseases; Hemic and Lymphatic Diseases; Anemia; Organic Chemicals; Carbohydrates; Coordination Complexes; Polysaccharides; Glucans; Dextrans; Iron-Dextran Complex
• Other Study ID Numbers: MU-CIRB 2022/313.1411

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No