Iron Deficiency Anemia, Iron Supplementation and Genomic Stability in Infants

Effectiveness of Weekly and Daily Iron Supplementation for the Prevention of Iron-deficiency Anemia in Infants. Impact on Genomic Stability

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.

Study Overview

• Status: Unknown
• Conditions: Iron-deficiency; Anemia
• Intervention / Treatment: Drug: Weekly Ferrous Sulfate; Drug: Daily Ferrous Sulfate

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 Type: Interventional
• Enrollment (Anticipated): 204
• Phase: Phase 4

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires
    • La Plata, Buenos Aires, Argentina, 1900
      • Recruiting
      • Instituto de Desarrollo e Investigaciones Pediátricas Prof. Dr. Fernando E. Viteri
      • Contact: Enrique Martins, Biochemist; Phone Number: 540221155444457; Email: enriqueflmartins@gmail.com
      • Contact: Ana Varea, Biochemist; Phone Number: 540221155411502; Email: anamvarea@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 months to 3 months (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Weekly Iron; Weekly ferrous sulfate: one dose (4mg/kg/week).	Drug: Weekly Ferrous Sulfate; Drops; Other Names: Fer-in-sol
Active Comparator: Daily Iron; Daily ferrous sulfate: one dose (1 mg/kg/day). Maximum daily dose: 40 mg	Drug: Daily Ferrous Sulfate; Drops; Other Names: Fer-in-sol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anemia	Hemoglobin <11.0 g/dL in 6 months old infants.	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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)	Through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Instituto de Desarrollo e Investigaciones Pediátricas Prof. Dr. Fernando E. Viteri
• Investigators: Study Director: Ana Varea, Biochemist, Instituto de Desarrollo e Investigaciones Pediátricas Prof. Dr. Fernando E. Viteri

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2017
• Primary Completion (Anticipated): March 1, 2019
• Study Completion (Anticipated): August 1, 2019

Study Registration Dates

• First Submitted: November 13, 2017
• First Submitted That Met QC Criteria: November 30, 2017
• First Posted (Actual): December 2, 2017

Study Record Updates

• Last Update Posted (Actual): February 15, 2019
• Last Update Submitted That Met QC Criteria: February 13, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: primary prevention; infant
• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Hematologic Diseases; Anemia, Hypochromic; Iron Metabolism Disorders; Anemia, Iron-Deficiency; Anemia; Genomic Instability
• Other Study ID Numbers: 20070773

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
• IPD Sharing Time Frame: Beginning 3 months following article publication. No end date.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No