A Phase 4 interventional study of Weekly Ferrous Sulfate and Daily Ferrous Sulfate in Anemia and Iron-deficiency, sponsored by Instituto de Desarrollo e Investigaciones Pediátricas Prof. Dr. Fernando E. Viteri. Status unknown at 1 site in Argentina. Open to participants aged 3 Months to 3 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-02-15.
Sponsored by Instituto de Desarrollo e Investigaciones Pediátricas Prof. Dr. Fernando E. Viteri · Phase 4, Interventional, and Prevention
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.
1,768 studies on the registry are indexed under Anemia; 244 are open to participants now.
This study's planned enrollment of 204 is above the median of 96 across 1,318 interventional studies indexed under Anemia.
Browse Anemia studies →Instituto de Desarrollo e Investigaciones Pediátricas Prof. Dr. Fernando E. Viteri is the lead sponsor of 5 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
Weekly ferrous sulfate: one dose (4mg/kg/week).
Drug: Weekly Ferrous Sulfate
Daily ferrous sulfate: one dose (1 mg/kg/day). Maximum daily dose: 40 mg
Drug: Daily Ferrous Sulfate
Drops
Also known as: Fer-in-sol
Drops
Also known as: Fer-in-sol
Anemia
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
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Beginning 3 months following article publication. No end date.
Access criteria: Researchers who provide a methodologically sound proposal.Proposals should be directed to enriqueflmartins@gmail.com To gain access, data requestors will need to sign a data access agreement.
This study is status unknown, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Ferrous sulfate
Instituto de Desarrollo e Investigaciones Pediátricas Prof. Dr. Fernando E. Viteri