Clinical trial NCT03359447: Iron Deficiency Anemia, Iron Supplementation and Genomic Stability in Infants
Official title: Effectiveness of Weekly and Daily Iron Supplementation for the Prevention of Iron-deficiency Anemia in Infants. Impact on Genomic Stability
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Anemia
Iron-deficiency
Keywords: infant
primary prevention
Lead sponsor: Instituto de Desarrollo e Investigaciones Pediátricas Prof. Dr. Fernando E. Viteri
Sponsor class: OTHER
First posted: 2017-12-02
Enrollment: 204
Sex: ALL
Minimum age (years): 3
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two main arms: weekly vs daily iron supplementation. Infants who are exclusively breast fed will be randomized into three groups: no iron supplementation, weekly iron supplementation and daily iron supplementation. Infants that are partially fed with infant formula will be randomized into two groups: weekly iron supplementation and daily iron supplementation.
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Anemia
timeFrame: 7 days
Secondary outcomes:
measure: Iron deficiency
timeFrame: 7 days
measure: Adverse effects
timeFrame: Through study completion, an average of 1 year
measure: Genomic Instability
timeFrame: 15 days
measure: Adherence
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: La Plata
country: Argentina
facility: Instituto de Desarrollo e Investigaciones Pediátricas Prof. Dr. Fernando E. Viteri
state: Buenos Aires
Study officials:
affiliation: Instituto de Desarrollo e Investigaciones Pediátricas Prof. Dr. Fernando E. Viteri
name: Ana Varea, Biochemist
role: STUDY_DIRECTOR
References: