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Search / Trial NCT06318858

Daily and Weekly Iron Supplementation in Infants

Launched by MAHIDOL UNIVERSITY · Mar 13, 2024

Trial Information

Current as of July 01, 2025

Recruiting

Keywords

Anemia Iron Status Infants Iron Supplementation

ClinConnect Summary

This clinical trial is studying the effects of giving iron supplements to infants aged 6 to 12 months. The goal is to see if giving iron daily works better than giving it weekly in helping to prevent anemia, a condition where there is not enough healthy red blood cells. Infants will be randomly assigned to one of the two groups: one will receive daily iron supplements for the first three months, followed by weekly supplements for another three months, while the other group will receive weekly supplements throughout the entire six months.

To be eligible for this trial, infants should be healthy, born full term, and weigh between 5.5 and 8.8 pounds at birth. They should also have a hemoglobin level of at least 10.5 g/dL and be planned to receive breast milk along with complementary foods. Infants with certain health conditions or those who have already taken iron supplements are not eligible. Participants in the trial will be closely monitored to check their anemia levels and iron status throughout the study. This research aims to find the best approach to support the iron needs of infants, which is important for their growth and development.

Gender

ALL

Eligibility criteria

  • 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

About Mahidol University

Mahidol University, a premier institution in Thailand, is dedicated to advancing healthcare through innovative research and education. As a leading sponsor of clinical trials, the university leverages its extensive expertise in medical and health sciences to facilitate rigorous scientific investigations aimed at improving patient care and public health outcomes. With a commitment to ethical practices and collaboration, Mahidol University fosters multidisciplinary approaches, engaging a diverse array of researchers and healthcare professionals to drive meaningful advancements in clinical research.

Locations

Sam Phran, Nakhon Pathom, Thailand

Patients applied

0 patients applied

Trial Officials

Tippawan Pongcharoen, PhD

Principal Investigator

Mahidol University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported