Daily and Weekly Iron Supplementation in Infants

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

RECRUITING

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-15

Study Completion Date

2024-10-14

Brief Summary

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This study aims to compare the efficacy of daily iron supplementation and weekly iron supplementation in infants aged 6-12 months on the prevalence of anemia, hemoglobin level, and serum ferritin levels. Infants will be enrolled at 6 months and will be randomly assigned to receive either daily or weekly iron supplementation for the first 3 months and will be followed by weekly iron supplementation for another 3 months.

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Detailed Description

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This study aims to compare the efficacy of daily iron supplementation and weekly iron supplementation in infants aged 6-12 months on the prevalence of anemia, hemoglobin level, and serum ferritin levels. Normal birth weight and term infants will be enrolled at 6 months based on the inclusion criteria. Eligible participants will be assessed at baseline, including anthropometry, dietary intake, and biochemistry (hemoglobin, iron status, vitamin A status, and inflammation). Participants will then be randomly assigned to receive either daily or weekly iron supplementation for the first 3 months. Participants will be followed up at 9 months for the same assessments and will receive weekly iron supplementation for another 3 months. Participants will be followed up at 12 months and the same assessments will be performed. After that, participants will go back to the routine health care service, weekly iron supplementation.

Conditions

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Anemia Iron Status Infants Iron

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

group 1: daily iron syrup supplementation group 2: weekly iron syrup supplementation

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Letter codes were assigned to the iron syrup and the placebo by researchers who have not involved in the study. The codes have been kept until data analysis and report writing are complete.

Study Groups

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Group 1 daily iron supplementation

12.5 mg daily iron syrup supplementation from 6-9 months old, followed by 12.5 mg weekly iron syrup supplementation from 9-12 months old.

Infants aged 6-9 months will receive two iron syrup bottles. One bottle aims for ingestion every Monday of the week, and one bottle aims for ingestion on other days of the week.

At ages 9-12 months, infants will receive an iron syrup bottle that aims for ingestion every Monday of the week.

Group Type EXPERIMENTAL

Iron supplement

Intervention Type DIETARY_SUPPLEMENT

Group 1: 12.5 mg daily iron syrup supplementation from 6-9 months old

Group 2 weekly iron supplementation

12.5 mg weekly iron syrup supplementation from 6-12 months old. Infants aged 6-9 months will receive an iron syrup bottle that aims for ingestion every Monday of the week and a placebo bottle that aims for ingestion on other days of the week.

At ages 9-12 months, infants will receive an iron syrup bottle that aims for ingestion every Monday of the week.

Group Type OTHER

Iron supplement

Intervention Type DIETARY_SUPPLEMENT

Group 1: 12.5 mg daily iron syrup supplementation from 6-9 months old

Interventions

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Iron supplement

Group 1: 12.5 mg daily iron syrup supplementation from 6-9 months old

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Apparently healthy infant, aged 6 months ± 2 weeks
* Having a birth weight between 2,500 and 4,000 grams
* Being born full term (37 to 41 weeks of age + 6 days)
* Having hemoglobin ≥ 10.5 g/dL
* Being planned to breastfeed with complementary food and/or complementary foods with formula milk

Exclusion Criteria

* Infants with chronic illnesses or thalassemia clinical signs such as anemia, enlarged liver, or spleen (if parental history suggests the child is at risk of developing a thalassemia disease that may not show clinical symptoms)
* Previously or currently taking an iron supplement

Minimum Eligible Age

6 Months

Maximum Eligible Age

12 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes