Iron Deficiency Anemia, Iron Supplementation and Genomic Stability in Infants

NCT03359447 | Unknown Phase 4

• 1 other identifier: 20070773
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 1

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.

Conditions

Anemia; Iron-deficiency

Keywords

infant; primary prevention

Outcome Measures

Primary Outcomes (1)

• Anemia

  Hemoglobin \<11.0 g/dL in 6 months old infants.

  7 days

Secondary Outcomes (4)

• Iron deficiency

  7 days

• Adverse effects

  Through study completion, an average of 1 year

• Genomic Instability

  15 days

• Adherence

  Through study completion, an average of 1 year

Study Arms (2)

Weekly Iron

EXPERIMENTAL

Weekly ferrous sulfate: one dose (4mg/kg/week).

Drug: Weekly Ferrous Sulfate

Daily Iron

ACTIVE COMPARATOR

Daily ferrous sulfate: one dose (1 mg/kg/day). Maximum daily dose: 40 mg

Drug: Daily Ferrous Sulfate

Interventions

Weekly Ferrous Sulfate DRUG

Drops

Also known as: Fer-in-sol

Weekly Iron

Daily Ferrous Sulfate DRUG

Drops

Also known as: Fer-in-sol

Daily Iron

Eligibility Criteria

• Age: 3 Months - 3 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• months old infants, clinically healthy, born to term (\>37 weeks), that weighted at birth between 2500 and 4000 g, that have normal prenatal records.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto de Desarrollo e Investigaciones Pediátricas Prof. Dr. Fernando E. Viteri: lead

Study Sites (1)

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

La Plata, Buenos Aires, 1900, Argentina

RECRUITING

MeSH Terms

Conditions

Anemia; Anemia, Iron-Deficiency

Interventions

ferrous sulfate

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Anemia, Hypochromic; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Ana Varea, Biochemist

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

  STUDY DIRECTOR

Central Study Contacts

Enrique Martins, Biochemist

CONTACT

540221155444457; enriqueflmartins@gmail.com

Ana Varea, Biochemist

CONTACT

540221155411502; anamvarea@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 13, 2017
• First Posted: December 2, 2017
• Study Start: August 1, 2017
• Primary Completion: March 1, 2019
• Study Completion: August 1, 2019
• Last Updated: February 15, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• 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.

Locations

AR (1)