Clinical trial NCT06318858: Daily and Weekly Iron Supplementation in Infants
Official title: Efficacy of Daily and Weekly Iron Supplementation on Anemia Prevalence in Thai Infants Aged 6-12 Months
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anemia
Iron Status
Infants
Iron
Keywords: Anemia
Iron status
Infants
Iron supplementation
Lead sponsor: Mahidol University
Sponsor class: OTHER
Collaborators: name: Suranaree University of Technology
First posted: 2024-03-19
Enrollment: 300
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: group 1: daily iron syrup supplementation group 2: weekly iron syrup supplementation
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

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

Primary outcomes:
measure: Anemia status
timeFrame: at aged 6, 9, and 12 months
measure: Iron status
timeFrame: at aged 6, 9, and 12 months
Secondary outcomes:
measure: Weight
timeFrame: at aged 6, 9, and 12 months
measure: Length
timeFrame: at aged 6, 9, and 12 months
measure: Dietary intake
timeFrame: at aged 6, 9, and 12 months
measure: Head circumference (HC)
timeFrame: at aged 6, 9, and 12 months
Other outcomes:
measure: Hemoglobin typing
timeFrame: at aged 12 months
measure: C-reactive protein (CRP)
timeFrame: at aged 6, 9, and 12 months
measure: Alpha-1 acid glycoprotein (AGP)
timeFrame: at aged 6, 9, and 12 months
measure: Serum transferrin receptor
timeFrame: at aged 6, 9, and 12 months
measure: Serum Retinol Binding Protein (RBP)
timeFrame: at aged 6, 9, and 12 months
Locations:
city: Sam Phran
country: Thailand
facility: Samphran District Hospital
state: Nakhon Pathom
Study officials:
affiliation: Mahidol University
name: Tippawan Pongcharoen, PhD
role: PRINCIPAL_INVESTIGATOR
References: