Anemia, Iron-deficiency
Conditions
Keywords
infant, primary 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.
Interventions
DRUGWeekly Ferrous Sulfate
Drops
Drops
Sponsors
Instituto de Desarrollo e Investigaciones Pediátricas Prof. Dr. Fernando E. Viteri
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
Outcomes assessor: the outcomes are defined by hemoglobin and ferritin (corrected by CRP), also genomic instability is defined by a laboratory result such as comet assay. The members of the laboratory will receive labeled specimens with a code unrelated to the allocated arm. The investigators that will analyze the data will not carry out the study. All the clinical data will be obtained by the care providers.
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.
Eligibility
Sex/Gender
ALL
Age
3 Months to 3 Months
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anemia | 7 days | Hemoglobin \<11.0 g/dL in 6 months old infants. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Iron deficiency | 7 days | 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. |
| Adverse effects | Through study completion, an average of 1 year | Frequency of at least one of the following during the three months intervention: rejection of food intake, constipation, vomiting, diarrhea, abdominal pain. |
| Genomic Instability | 15 days | 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. |
| Adherence | Through study completion, an average of 1 year | 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) |
Countries
Argentina
Contacts
Primary ContactEnrique Martins, Biochemist
Backup ContactAna Varea, Biochemist
Outcome results
None listed