Iron Deficiency Anemia, Iron Supplementation and Genomic Stability in Infants

Anemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03359447
• Other study ID #: 20070773
• Status: Recruiting
• Phase: Phase 4
• Start date: August 1, 2017
• Est. completion date: August 1, 2019

Study information

• Verified date: February 2019
• Source: Instituto de Desarrollo e Investigaciones Pediátricas Prof. Dr. Fernando E. Viteri
• Contact: Enrique Martins, Biochemist
• Phone: 540221155444457
• Email: enriqueflmartins[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 204
• Est. completion date: August 1, 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Months to 3 Months

Eligibility

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.

Related Conditions & MeSH terms

• Anemia
• Anemia, Iron-Deficiency
• Iron-deficiency

Intervention

Drug:
• Weekly Ferrous Sulfate
Drops
• Daily Ferrous Sulfate
Drops

Locations

Country	Name	City	State
Argentina	Instituto de Desarrollo e Investigaciones Pediátricas Prof. Dr. Fernando E. Viteri	La Plata	Buenos Aires

Sponsors (1)

Lead Sponsor	Collaborator
Instituto de Desarrollo e Investigaciones Pediátricas Prof. Dr. Fernando E. Viteri

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anemia	Hemoglobin <11.0 g/dL in 6 months old infants.	7 days
Secondary	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
Secondary	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
Secondary	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
Secondary	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