Clinical trial NCT06283342: Prophylactic Iron and Nutrition in Preventing Infant Iron Deficiency
Official title: The Role of Prophylactic Iron Use and Nutrition in Preventing Iron Deficiency in Infancy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Iron Deficiency Anemia in Childbirth
Infant Nutrition Disorders
Iron Deficiencies
Keywords: prophylactic iron
infant nutrition
iron deficiency prevention
pediatric health
Lead sponsor: Konya Meram State Hospital
Sponsor class: OTHER
First posted: 2024-02-28
Enrollment: 2
Sex: ALL
Minimum age (years): 6
Maximum age (years): 24
Standard ages: CHILD
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_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.

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Ferritine level
timeFrame: day 1
Secondary outcomes:
measure: Hemoglobin level
timeFrame: day 1
measure: Prophylactic iron use rate
timeFrame: 15 days
measure: Iron-sufficient supplementary food intake rate of babies
timeFrame: 15 days
measure: Breast milk usage rate
timeFrame: 15 days
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Konya Training and Research Hospital
Study officials:
References: