NCT03359447

Iron Deficiency Anemia, Iron Supplementation and Genomic Stability in Infants

Effectiveness of Weekly and Daily Iron Supplementation for the Prevention of Iron-deficiency Anemia in Infants. Impact on Genomic Stability

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 204 (estimated)
• Sponsor: Instituto de Desarrollo e Investigaciones Pediátricas Prof. Dr. Fernando E. Viteri · Academic / Other
• Sex: All
• Age: 3 Months – 3 Months
• Healthy volunteers: Accepted

Summary

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.

Detailed 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.

Conditions

• Anemia
• Iron-deficiency

Interventions

Type	Name	Description
DRUG	Weekly Ferrous Sulfate	Drops
DRUG	Daily Ferrous Sulfate	Drops

Timeline

• Start date: 2017-08-01
• Primary completion: 2019-03-01
• Completion: 2019-08-01
• First posted: 2017-12-02
• Last updated: 2019-02-15

Locations

1 site across 1 country: Argentina