Daily and Weekly Iron Supplementation in Infants

Not Applicable

Recruiting

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Group 2 weekly iron supplementation	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.
Group 1 daily iron supplementation	Iron supplement	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.

Primary Outcome Measures

Name	Time	Method
Anemia status	at aged 6, 9, and 12 months	Hemoglobin concentration will be assessed and classified as anemia or non-anemia.
Iron status	at aged 6, 9, and 12 months	Serum ferritin will be assessed to reflect iron status

Secondary Outcome Measures

Name	Time	Method
Weight	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
Length	at aged 6, 9, and 12 months	Length will be assessed, and length-for-age Z scores and weight-for-length will be generated
Head circumference (HC)	at aged 6, 9, and 12 months	HC will be assessed, and head circumference-for-age Z scores will be generated
Dietary intake	at aged 6, 9, and 12 months	Dietary intake will be assessed using the 24-hr dietary recall for 3 days

Locations (1): Samphran District Hospital
🇹🇭
Sam Phran, Nakhon Pathom, Thailand

Receive instant email notifications about changes in this clinical trial

Receive instant email notifications about changes in this clinical trial