Prophylactic Iron and Nutrition in Preventing Infant Iron Deficiency

Completed

• Conditions: Infant Nutrition Disorders; Iron Deficiencies; Iron Deficiency Anemia in Childbirth

• Registration Number: NCT06283342
• Lead Sponsor: Konya Meram State Hospital

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.

Study Timeline

• Study Start: 2018-01-01
• Primary Completion: 2019-01-01
• Study Completion: 2019-02-01
• Status Verified: 2024-02
• Study First Submitted: 2024-02-20
• Study First Submitted QC: 2024-02-27
• Last Update Submitted: 2024-02-27
• Study First Posted: 2024-02-28
• Last Update Posted: 2024-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Ferritine level	day 1	Ferritin level below 12 mg/L was considered iron deficiency.

Secondary Outcome Measures

Name	Time	Method
Iron-sufficient supplementary food intake rate of babies	15 days	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.
Breast milk usage rate	15 days	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.
Prophylactic iron use rate	15 days	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.
Hemoglobin level	day 1	Hemoglobin (Hb) values below 11 g/dL were considered as having anemia

Trial Locations

Locations (1)

Konya Training and Research Hospital; 🇹🇷 Konya, Turkey