Daily and Weekly Iron Supplementation in Infants

Anemia Clinical Trial

Official title:

Efficacy of Daily and Weekly Iron Supplementation on Anemia Prevalence in Thai Infants Aged 6-12 Months

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06318858
• Other study ID #: MU-CIRB 2022/313.1411
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Anemia
• Infants
• Iron
• Iron Status

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