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Completed

NCT Number: NCT06283342

Prophylactic Iron and Nutrition in Preventing Infant Iron Deficiency

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.

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Key information

Age range

6 month–24 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Konya Training and Research Hospital

Konya, 42090, Turkey (Türkiye)

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Ferritine level

    Time frame: day 1

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

Secondary outcomes

  1. Hemoglobin level

    Time frame: day 1

    Hemoglobin (Hb) values below 11 g/dL were considered as having anemia

  2. Prophylactic iron use rate

    Time frame: 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.

  3. Iron-sufficient supplementary food intake rate of babies

    Time frame: 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.
  4. Breast milk usage rate

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Konya Meram State Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Feb 28, 2024
Registry last updated
Feb 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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