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| Name | Class |
|---|---|
| Suranaree University of Technology | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 daily iron supplementation | Experimental | 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. |
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| Group 2 weekly iron supplementation | Other | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iron supplement | Dietary Supplement | Group 1: 12.5 mg daily iron syrup supplementation from 6-9 months old |
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| Measure | Description | Time Frame |
|---|---|---|
| Anemia status | Hemoglobin concentration will be assessed and classified as anemia or non-anemia. | at aged 6, 9, and 12 months |
| Iron status | Serum ferritin will be assessed to reflect iron status | at aged 6, 9, and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Length | Length will be assessed, and length-for-age Z scores and weight-for-length will be generated |
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin typing | Hemoglobin typing will be assessed | at aged 12 months |
| C-reactive protein (CRP) | High sensitivity CRP will be analyzed and will be used for the adjustment of serum ferritin |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tippawan Pongcharoen, PhD | Mahidol University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samphran District Hospital | Sam Phran | Changwat Nakhon Pathom | 73110 | Thailand |
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| ID | Term |
|---|---|
| D000740 | Anemia |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D007505 | Iron-Dextran Complex |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D003911 | Dextrans |
| D005936 | Glucans |
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group 1: daily iron syrup supplementation group 2: weekly iron syrup supplementation
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Letter codes were assigned to the iron syrup and the placebo by researchers who have not involved in the study. The codes have been kept until data analysis and report writing are complete.
| at aged 6, 9, and 12 months |
| Dietary intake | Dietary intake will be assessed using the 24-hr dietary recall for 3 days | at aged 6, 9, and 12 months |
| Head circumference (HC) | HC will be assessed, and head circumference-for-age Z scores will be generated | at aged 6, 9, and 12 months |
| at aged 6, 9, and 12 months |
| 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 |
| Serum transferrin receptor | Serum transferrin receptor will be assessed to reflect iron status | at aged 6, 9, and 12 months |
| Serum Retinol Binding Protein (RBP) | RBP will be assessed to reflect vitamin A status | at aged 6, 9, and 12 months |
| D011134 |
| Polysaccharides |
| D002241 | Carbohydrates |