NCT06318858

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 15, 2023

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

March 13, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 19, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 14, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 14, 2024

Completed
Last Updated

April 5, 2024

Status Verified

April 1, 2024

Enrollment Period

1.4 years

First QC Date

March 13, 2024

Last Update Submit

April 4, 2024

Conditions

AnemiaIron StatusInfantsIron

Keywords

AnemiaIron statusInfantsIron supplementation

Outcome Measures

Primary Outcomes (2)

  • 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

Secondary Outcomes (4)

  • Weight

    at aged 6, 9, and 12 months

  • Length

    at aged 6, 9, and 12 months

  • Dietary intake

    at aged 6, 9, and 12 months

  • Head circumference (HC)

    at aged 6, 9, and 12 months

Other Outcomes (5)

  • Hemoglobin typing

    at aged 12 months

  • C-reactive protein (CRP)

    at aged 6, 9, and 12 months

  • Alpha-1 acid glycoprotein (AGP)

    at aged 6, 9, and 12 months

  • +2 more other outcomes

Study Arms (2)

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.

Dietary Supplement: Iron supplement

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.

Dietary Supplement: Iron supplement

Interventions

Iron supplementDIETARY_SUPPLEMENT

Group 1: 12.5 mg daily iron syrup supplementation from 6-9 months old

Group 1 daily iron supplementationGroup 2 weekly iron supplementation

Eligibility Criteria

Age6 Months - 12 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samphran District Hospital

Sam Phran, Changwat Nakhon Pathom, 73110, Thailand

RECRUITING

MeSH Terms

Conditions

Anemia

Interventions

Iron-Dextran Complex

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsDextransGlucansPolysaccharidesCarbohydrates

Study Officials

  • Tippawan Pongcharoen, PhD

    Mahidol University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tippawan Pongcharoen, PhD

CONTACT

66813749901tippawan.pon@mahidol.ac.th

Poonyanuch Chongjaroenjai, MD

CONTACT

66899497799poonyanuch@sut.ac.th

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Masking Details
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.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: group 1: daily iron syrup supplementation group 2: weekly iron syrup supplementation
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 13, 2024

First Posted

March 19, 2024

Study Start

March 15, 2023

Primary Completion

August 14, 2024

Study Completion

October 14, 2024

Last Updated

April 5, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

TH(1)