Samphran District Hospital
Sam Phran, Changwat Nakhon Pathom, 73110, Thailand
NCT Number: NCT06318858
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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Notify Me6 month–12 month
All sexes
Interventional
Not applicable
Sam Phran, Changwat Nakhon Pathom, 73110, Thailand
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Group 1: 12.5 mg daily iron syrup supplementation from 6-9 months old
Time frame: at aged 6, 9, and 12 months
Hemoglobin concentration will be assessed and classified as anemia or non-anemia.
Time frame: at aged 6, 9, and 12 months
Serum ferritin will be assessed to reflect iron status
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
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
Time frame: at aged 6, 9, and 12 months
Dietary intake will be assessed using the 24-hr dietary recall for 3 days
Time frame: at aged 6, 9, and 12 months
HC will be assessed, and head circumference-for-age Z scores will be generated
Time frame: at aged 12 months
Hemoglobin typing will be assessed
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
Time frame: at aged 6, 9, and 12 months
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 will be assessed to reflect iron status
Time frame: at aged 6, 9, and 12 months
RBP will be assessed to reflect vitamin A status
Mahidol University
Other
Efficacy of Daily and Weekly Iron Supplementation on Anemia Prevalence in Thai Infants Aged 6-12 Months
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