Anemia Clinical Trial
Official title:
Efficacy of Daily and Weekly Iron Supplementation on Anemia Prevalence in Thai Infants Aged 6-12 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. 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.
Status | Recruiting |
Enrollment | 300 |
Est. completion date | October 14, 2024 |
Est. primary completion date | August 14, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 6 Months to 12 Months |
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 |
Country | Name | City | State |
---|---|---|---|
Thailand | Samphran District Hospital | Sam Phran | Nakhon Pathom |
Lead Sponsor | Collaborator |
---|---|
Mahidol University | Suranaree University of Technology |
Thailand,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Hemoglobin typing | Hemoglobin typing will be assessed | at aged 12 months | |
Other | C-reactive protein (CRP) | High sensitivity CRP will be analyzed and will be used for the adjustment of serum ferritin | at aged 6, 9, and 12 months | |
Other | Alpha-1 acid glycoprotein (AGP) | AGP will be analyzed and will be used for the adjustment of serum ferritin | at aged 6, 9, and 12 months | |
Other | Serum transferrin receptor | Serum transferrin receptor will be assessed to reflect iron status | at aged 6, 9, and 12 months | |
Other | Serum Retinol Binding Protein (RBP) | RBP will be assessed to reflect vitamin A status | at aged 6, 9, and 12 months | |
Primary | Anemia status | Hemoglobin concentration will be assessed and classified as anemia or non-anemia. | at aged 6, 9, and 12 months | |
Primary | Iron status | Serum ferritin will be assessed to reflect iron status | at aged 6, 9, and 12 months | |
Secondary | Weight | Body weight will be assessed, and weight-for-age and weight-for-length Z scores will be generated | at aged 6, 9, and 12 months | |
Secondary | Length | Length will be assessed, and length-for-age Z scores and weight-for-length will be generated | at aged 6, 9, and 12 months | |
Secondary | Dietary intake | Dietary intake will be assessed using the 24-hr dietary recall for 3 days | at aged 6, 9, and 12 months | |
Secondary | Head circumference (HC) | HC will be assessed, and head circumference-for-age Z scores will be generated | at aged 6, 9, and 12 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
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