Efficacy of Daily and Weekly Iron Supplementation on Anemia Prevalence in Thai Infants Aged 6-12 Months
| Registry | NCT06318858 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: triple, prevention |
| Enrollment | 287 (Actual) |
| Sponsor | Mahidol University (Other); collaborators: Suranaree University of Technology |
| Conditions | Anemia, Iron Status, Infants, Iron |
| Interventions | Iron supplement (Dietary supplement) |
| Dates | start 2023-03-15, primary completion 2024-10-25, completion 2025-05-14, first posted 2024-03-19, last updated 2026-06-01 |
| Locations | 1 site in Thailand |
Related Papers Related Patents Related Grants Related Experts
All trials for Anemia All trials for Iron Status All trials of Iron supplement
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Group 1 daily iron supplementation | Experimental | Dietary Supplement: 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. |
| Group 2 weekly iron supplementation | Other | 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. |
Sex: All, ages: 6 Months to 12 Months, accepts healthy volunteers
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
| Facility | City | Country | Status |
|---|---|---|---|
| Samphran District Hospital | Sam Phran, Changwat Nakhon Pathom | Thailand |