Anemia, Iron Status, Infants, Iron
Conditions
Keywords
Anemia, Iron status, Infants, Iron supplementation
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.
Interventions
DIETARY_SUPPLEMENTIron supplement
Group 1: 12.5 mg daily iron syrup supplementation from 6-9 months old
Sponsors
Suranaree University of Technology
Mahidol University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
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.
Intervention model description
group 1: daily iron syrup supplementation group 2: weekly iron syrup supplementation
Eligibility
Sex/Gender
ALL
Age
6 Months to 12 Months
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Dietary intake | at aged 6, 9, and 12 months | Dietary intake will be assessed using the 24-hr dietary recall for 3 days |
| Head circumference (HC) | at aged 6, 9, and 12 months | HC will be assessed, and head circumference-for-age Z scores will be generated |
Other
| Measure | Time frame | Description |
|---|---|---|
| C-reactive protein (CRP) | at aged 6, 9, and 12 months | High sensitivity CRP will be analyzed and will be used for the adjustment of serum ferritin |
| Alpha-1 acid glycoprotein (AGP) | at aged 6, 9, and 12 months | AGP will be analyzed and will be used for the adjustment of serum ferritin |
| Serum transferrin receptor | at aged 6, 9, and 12 months | Serum transferrin receptor will be assessed to reflect iron status |
| Serum Retinol Binding Protein (RBP) | at aged 6, 9, and 12 months | RBP will be assessed to reflect vitamin A status |
| Hemoglobin typing | at aged 12 months | Hemoglobin typing will be assessed |
Countries
Thailand
Contacts
Primary ContactTippawan Pongcharoen, PhD
Backup ContactPoonyanuch Chongjaroenjai, MD
Outcome results
None listed