An interventional study of Iron supplement in Anemia, Iron Status and Infants, sponsored by Mahidol University. Completed at 1 site in Thailand. Open to participants aged 6 Months to 12 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-01.
Sponsored by Mahidol University · Not applicable, Interventional, and Prevention
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.
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.
1,733 studies on the registry are indexed under Anemia; 246 are open to participants now.
This study's enrollment of 287 is above the median of 94 across 1,291 interventional studies indexed under Anemia.
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Exclusion Criteria:
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
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
Anemia status
Hemoglobin concentration will be assessed and classified as anemia or non-anemia.
Time frame: at aged 6, 9, and 12 months
Iron status
Serum ferritin will be assessed to reflect iron status
Time frame: at aged 6, 9, and 12 months
Weight
Body weight will be assessed, and weight-for-age and weight-for-length Z scores will be generated
Time frame: 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
Time frame: at aged 6, 9, and 12 months
Dietary intake
Dietary intake will be assessed using the 24-hr dietary recall for 3 days
Time frame: at aged 6, 9, and 12 months
Head circumference (HC)
HC will be assessed, and head circumference-for-age Z scores will be generated
Time frame: at aged 6, 9, and 12 months
Hemoglobin typing
Hemoglobin typing will be assessed
Time frame: at aged 12 months
C-reactive protein (CRP)
High sensitivity CRP will be analyzed and will be used for the adjustment of serum ferritin
Time frame: 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
Time frame: at aged 6, 9, and 12 months
Serum transferrin receptor
Serum transferrin receptor will be assessed to reflect iron status
Time frame: at aged 6, 9, and 12 months
Serum Retinol Binding Protein (RBP)
RBP will be assessed to reflect vitamin A status
Time frame: at aged 6, 9, and 12 months
Plan to share: No
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Mahidol University