Prophylactic Iron and Nutrition in Preventing Infant Iron Deficiency

Infant Nutrition Disorders Clinical Trial

Official title:

The Role of Prophylactic Iron Use and Nutrition in Preventing Iron Deficiency in Infancy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06283342
• Other study ID #: Konya Pediatric Hematology
• Status: Completed
• Start date: January 1, 2018
• Est. completion date: February 1, 2019

Study information

• Verified date: February 2024
• Source: Konya Meram State Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: February 1, 2019
• Est. primary completion date: January 1, 2019
• Gender: All
• Age group: 6 Months to 24 Months

Eligibility

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

Related Conditions & MeSH terms

• Anemia, Iron-Deficiency
• Infant Nutrition Disorders
• Nutrition Disorders

Locations

Country	Name	City	State
Turkey	Konya Training and Research Hospital	Konya

Sponsors (1)

Lead Sponsor	Collaborator
Konya Meram State Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ferritine level	Ferritin level below 12 mg/L was considered iron deficiency.	day 1
Secondary	Hemoglobin level	Hemoglobin (Hb) values below 11 g/dL were considered as having anemia	day 1
Secondary	Prophylactic iron use rate	Giving 10 mg/day iron drops to babies starting from the 4th month was considered as the correct prophylaxis recommendation. Prophylactic iron use rates were calculated by dividing those using iron prophylaxis in all groups by the number of participants in the groups.	15 days
Secondary	Iron-sufficient supplementary food intake rate of babies	Babies whose mothers answered "yes" to at least two of the following questions in the survey evaluating babies' iron-sufficient supplementary food intake were considered to be fed adequately in terms of iron: Does your baby eat 1 egg at least 3 days a week?; Does your baby eat meat the size of 2 meatballs 2 days a week?; Does your baby eat legumes at least 3 times a week? This ratio was calculated by dividing the number of adequately nourished participants by the total number of participants in the group.	15 days
Secondary	Breast milk usage rate	Exclusive breastfeeding for at least 6 months after birth was considered adequate breast milk intake. Those who breastfed during this period were considered to have used sufficient breast milk. The breast milk usage rate was found by dividing those who received adequate breast milk by the participants in the group.	15 days