Iron Deficiency Anemia, Iron Supplementation and Genomic Stability in Infants

Phase 4

• Conditions: Iron-deficiency; Anemia
• Interventions: Drug: Weekly Ferrous Sulfate; Drug: Daily Ferrous Sulfate

• Registration Number: NCT03359447
• Lead Sponsor: Instituto de Desarrollo e Investigaciones Pediátricas Prof. Dr. Fernando E. Viteri

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.

Study Timeline

• Study Start: 2017-08-01
• Study First Submitted: 2017-11-13
• Study First Submitted QC: 2017-11-30
• Study First Posted: 2017-12-02
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-13
• Last Update Posted: 2019-02-15
• Primary Completion: 2019-03
• Study Completion: 2019-08-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 204

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Weekly Iron	Weekly Ferrous Sulfate	Weekly ferrous sulfate: one dose (4mg/kg/week).
Daily Iron	Daily Ferrous Sulfate	Daily ferrous sulfate: one dose (1 mg/kg/day). Maximum daily dose: 40 mg

Primary Outcome Measures

Name	Time	Method
Anemia	7 days	Hemoglobin \<11.0 g/dL in 6 months old infants.

Secondary Outcome Measures

Name	Time	Method
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)
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.
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.

Trial Locations

Locations (1)

Instituto de Desarrollo e Investigaciones Pediátricas Prof. Dr. Fernando E. Viteri; 🇦🇷 La Plata, Buenos Aires, Argentina