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Completed

NCT Number: NCT06318858

Daily and Weekly Iron Supplementation in Infants

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.

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Key information

Age range

6 month–12 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Samphran District Hospital

Sam Phran, Changwat Nakhon Pathom, 73110, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Iron Supplement

Dietary Supplement

Group 1: 12.5 mg daily iron syrup supplementation from 6-9 months old

Primary outcomes

  1. Anemia status

    Time frame: at aged 6, 9, and 12 months

    Hemoglobin concentration will be assessed and classified as anemia or non-anemia.

  2. Iron status

    Time frame: at aged 6, 9, and 12 months

    Serum ferritin will be assessed to reflect iron status

Secondary outcomes

  1. Weight

    Time frame: at aged 6, 9, and 12 months

    Body weight will be assessed, and weight-for-age and weight-for-length Z scores will be generated

  2. Length

    Time frame: at aged 6, 9, and 12 months

    Length will be assessed, and length-for-age Z scores and weight-for-length will be generated

  3. Dietary intake

    Time frame: at aged 6, 9, and 12 months

    Dietary intake will be assessed using the 24-hr dietary recall for 3 days

  4. Head circumference (HC)

    Time frame: at aged 6, 9, and 12 months

    HC will be assessed, and head circumference-for-age Z scores will be generated

Other outcomes

  1. Hemoglobin typing

    Time frame: at aged 12 months

    Hemoglobin typing will be assessed

  2. C-reactive protein (CRP)

    Time frame: at aged 6, 9, and 12 months

    High sensitivity CRP will be analyzed and will be used for the adjustment of serum ferritin

  3. Alpha-1 acid glycoprotein (AGP)

    Time frame: at aged 6, 9, and 12 months

    AGP will be analyzed and will be used for the adjustment of serum ferritin

  4. Serum transferrin receptor

    Time frame: at aged 6, 9, and 12 months

    Serum transferrin receptor will be assessed to reflect iron status

  5. Serum Retinol Binding Protein (RBP)

    Time frame: at aged 6, 9, and 12 months

    RBP will be assessed to reflect vitamin A status

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Collaborators

  • Suranaree University of Technology

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Mar 19, 2024
Registry last updated
Jun 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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