Prophylactic Iron and Nutrition in Preventing Infant Iron Deficiency

NCT ID: NCT06283342

Last Updated: 2024-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-01

Study Completion Date

2019-02-01

Brief Summary

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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.

Detailed Description

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Iron plays an important role in oxidation and reduction reactions, which have a very important place in the continuation of life. Iron plays an essential role in these reactions because it can easily gain and lose electrons in redox reactions. Iron is mostly found in the heme molecule in organisms. However, iron has structural and functional importance for many enzymes and proteins other than heme. Iron deficiency (ID) is the most common nutritional deficiency in children worldwide. ID is more common in socio-economically developing geographies. However, it is still an important problem in developed countries. A plasma ferritin level below 12 mg/L is defined as ID, which is often used synonymously with iron deficiency anemia (IDA). However, ID develops before anemia occurs. Weakness, fatigue, tiring quickly, insomnia, and regression in neuro-cognitive functions may occur in ID that precedes the signs of anemia. With the development of anemia, the clinical diagnosis of IDA is fully revealed.

In ID that occurs in infancy, psychomotor development is adversely affected, and the development of cognitive functions slows down or even stops. Immune system functions regress. Although iron treatment can reverse these negative effects, some effects are permanent. Therefore, prevention of ID is more important than treatment. In addition, it is easier and cheaper to prevent ID and IDA than to treat them. It is a health policy to recommend iron prophylaxis to children aged 4-12 months in the Republic of Turkey.

Adding iron-rich foods to the diet, adequate breast milk intake, and prophylaxis with iron preparations can be used to prevent ID and IDA. However, there are different data in the literature on the use of prophylactic iron preparations.

Conditions

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Iron Deficiency Anemia in Childbirth Infant Nutrition Disorders Iron Deficiencies

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Iron deficiency group

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

No interventions assigned to this group

Not iron deficiency group

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

No interventions assigned to this 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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

6 Months

Maximum Eligible Age

24 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Konya Meram State Hospital

OTHER

Sponsor Role lead

Responsible Party

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Alpaslan Şahin

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Konya Training and Research Hospital

Konya, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type DERIVED
PMID: 40527768 (View on PubMed)

Other Identifiers

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Konya Pediatric Hematology

Identifier Type: -

Identifier Source: org_study_id

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