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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06318858
Other study ID # MU-CIRB 2022/313.1411
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 15, 2023
Est. completion date October 14, 2024

Study information

Verified date April 2024
Source Mahidol University
Contact Tippawan Pongcharoen, PhD
Phone 66813749901
Email tippawan.pon@mahidol.ac.th
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Iron supplement
Group 1: 12.5 mg daily iron syrup supplementation from 6-9 months old

Locations

Country Name City State
Thailand Samphran District Hospital Sam Phran Nakhon Pathom

Sponsors (2)

Lead Sponsor Collaborator
Mahidol University Suranaree University of Technology

Country where clinical trial is conducted

Thailand, 

Outcome

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
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