Daily and Weekly Iron Supplementation in Infants

Last updated: April 4, 2024
Sponsor: Mahidol University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Anemia

Treatment

Iron supplement

Clinical Study ID

NCT06318858
MU-CIRB 2022/313.1411
  • Ages 6-12
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

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 withformula milk

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 300
Treatment Group(s): 1
Primary Treatment: Iron supplement
Phase:
Study Start date:
March 15, 2023
Estimated Completion Date:
October 14, 2024

Study 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.

Connect with a study center

  • Samphran District Hospital

    Sam Phran, Nakhon Pathom 73110
    Thailand

    Active - Recruiting

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