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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
204
Drops
Drops
Instituto de Desarrollo e Investigaciones Pediátricas Prof. Dr. Fernando E. Viteri
La Plata, Buenos Aires, Argentina
RECRUITINGAnemia
Hemoglobin \<11.0 g/dL in 6 months old infants.
Time frame: 7 days
Iron deficiency
Serum Ferritin \<12 ng/ml in 6 months old infants. If C-reactive protein \> 5 mg/L, Iron deficiency is redefined as Serum Ferritin \<30 ng/ml.
Time frame: 7 days
Adverse effects
Frequency of at least one of the following during the three months intervention: rejection of food intake, constipation, vomiting, diarrhea, abdominal pain.
Time frame: Through study completion, an average of 1 year
Genomic Instability
One of the following indicators is altered. Genomic damage: Comet assay: damage index (ID) over 200 cells. 8-oxo-dGuanosine. Oxidative Stress: catalase activity, superoxide dismutase activity, Tbars.
Time frame: 15 days
Adherence
Low adherence: 1. Less than 50% of the drug was given to the infant (according to the remaining volume of the drug in its recipient) 2. Less tha 50% of the allocated intakes (according to care-taker registration on an almanaq)
Time frame: Through study completion, an average of 1 year
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