NCT06283342

Brief Summary

This study aimed to reveal the effects of prophylactic iron preparations, adequate breast milk intake, and iron-rich supplementary food intake in the prevention of IDA (iron deficiency anemia) and ID (iron deficiency) in infancy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
5.1 years until next milestone

First Submitted

Initial submission to the registry

February 20, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 28, 2024

Completed
Last Updated

February 28, 2024

Status Verified

February 1, 2024

Enrollment Period

1 year

First QC Date

February 20, 2024

Last Update Submit

February 27, 2024

Conditions

Keywords

prophylactic ironinfant nutritioniron deficiency preventionpediatric health

Outcome Measures

Primary Outcomes (1)

  • Ferritine level

    Ferritin level below 12 mg/L was considered iron deficiency.

    day 1

Secondary Outcomes (4)

  • Hemoglobin level

    day 1

  • Prophylactic iron use rate

    15 days

  • Iron-sufficient supplementary food intake rate of babies

    15 days

  • Breast milk usage rate

    15 days

Study Arms (4)

Iron deficiency group

Patients with a ferritin level below 12 mg/L were considered to have Iron deficiency group.

Not iron deficiency group

Patients with a ferritin level above 12 mg/L were considered to have not iron deficiency group.

Iron deficiency anemia group

Patients with ferritin level below 12 mg/L and hemoglobin (Hb) value below 11 g/dL were considered to have IDA.

Not iron deficiency anemia group

Patients with ferritin level below 12 mg/L and hemoglobin (Hb) value above 11 g/dL were considered to have Not iron deficiency anemia group.

Eligibility Criteria

Age6 Months - 24 Months
Sexall(Gender-based eligibility)
Gender Eligibility DetailsPatients aged between 6-24 months and admitted to the general pediatrics outpatient clinic were included in the study
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Study population include children aged 6-24 months, who were admitted to the general pediatric outpatient clinic of our hospital between January 1st, 2018, and February 1st, 2019.

You may qualify if:

  • Patients aged between 6-24 months and admitted to the general pediatrics outpatient clinic

You may not qualify if:

  • Chronic disease
  • Blood transfusion history,
  • Thalassemia carrier status
  • Clinical diagnosis of infection or elevated C-reactive protein (CRP)
  • Patients who received iron deficiency or iron deficiency anemia treatment
  • Those who were born prematurely
  • Patients with low birth weight

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Konya Training and Research Hospital

Konya, 42090, Turkey (Türkiye)

Location

Related Publications (1)

  • Simsek A, Energin VM. The role of prophylactic iron utilization and nutrition to prevent iron deficiency in infancy: Prospective cohort study. Medicine (Baltimore). 2025 Jun 13;104(24):e42947. doi: 10.1097/MD.0000000000042947.

MeSH Terms

Conditions

Infant Nutrition DisordersIron Deficiencies

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic DiseasesIron Metabolism DisordersMetabolic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 20, 2024

First Posted

February 28, 2024

Study Start

January 1, 2018

Primary Completion

January 1, 2019

Study Completion

February 1, 2019

Last Updated

February 28, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

There are no plans to make individual participant data (IPD) available to other researchers

Locations