Iron Deficiency Anemia, Iron Supplementation and Genomic Stability in Infants

Instituto de Desarrollo e Investigaciones Pediátricas Prof. Dr. Fernando E. Viteri

Status and phase: Unknown; Phase 4

Conditions: Anemia; Iron-deficiency

Treatments: Drug: Weekly Ferrous Sulfate; Drug: Daily Ferrous Sulfate

Study type: Interventional

Funder types: Other

Identifiers

NCT03359447

20070773

Details and patient eligibility

About

This study compares weekly versus daily administration of iron for prevention of anemia in 6 months old infants. One third of the infants that are exclusively breast fed will not receive iron, the second third will receive iron weekly and the last third will receive iron daily. Half of the infants that take infant formula will receive iron weekly and the other half will receive iron daily.

Full description

Iron deficiency is the most prevalent nutritional deficiency and the main cause of anemia. It's estimated that 43% of pre-school children worldwide are anemic, in Argentina a national survey carried out in 2007 (last survey), showed that 34.5% of children less than 2 years old were anemic and that 50.8% of children 6 to 9 months old were anemic. Although there is a consensus on iron supplementation as a preventive strategy for anemia in infants, there is a poor adherence due mainly to mild gastrointestinal adverse effects and low prescription rates from pediatricians. On the other hand, the excess of iron can lead to genomic instability with structural and functional alterations on proteins, lipids and DNA. Weekly administration of iron has been proposed as an alternative of similar efficacy and higher effectiveness in older children and pregnant women, but sufficient evidence for infants is lacking.

Enrollment: 204 estimated patients

Sex: All

Ages: 3 to 3 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 3 months old infants, clinically healthy, born to term (>37 weeks), that weighted at birth between 2500 and 4000 g, that have normal prenatal records.

Exclusion criteria

• anemic or iron deficient infants, or that have a chronic pathology, or that have undergone an acute pathology in the previous 15 days. Children that are receiving antibiotics or vitamin supplements.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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204 participants in 2 patient groups

Weekly Iron

Experimental group

Description:

Weekly ferrous sulfate: one dose (4mg/kg/week).

Treatment:

Drug: Weekly Ferrous Sulfate

Daily Iron

Active Comparator group

Description:

Daily ferrous sulfate: one dose (1 mg/kg/day). Maximum daily dose: 40 mg

Treatment:

Drug: Daily Ferrous Sulfate