Iron Deficiency Anemia, Iron Supplementation and Genomic Stability in Infants
Primary Purpose
Anemia, Iron-deficiency
Status
Unknown status
Phase
Phase 4
Locations
Argentina
Study Type
Interventional
Intervention
Weekly Ferrous Sulfate
Daily Ferrous Sulfate
Sponsored by
About this trial
This is an interventional prevention trial for Anemia focused on measuring infant, primary prevention
Eligibility Criteria
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.
Sites / Locations
- Instituto de Desarrollo e Investigaciones Pediátricas Prof. Dr. Fernando E. ViteriRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Weekly Iron
Daily Iron
Arm Description
Weekly ferrous sulfate: one dose (4mg/kg/week).
Daily ferrous sulfate: one dose (1 mg/kg/day). Maximum daily dose: 40 mg
Outcomes
Primary Outcome Measures
Anemia
Hemoglobin <11.0 g/dL in 6 months old infants.
Secondary Outcome Measures
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.
Adverse effects
Frequency of at least one of the following during the three months intervention: rejection of food intake, constipation, vomiting, diarrhea, abdominal pain.
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.
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)
Full Information
NCT ID
NCT03359447
First Posted
November 13, 2017
Last Updated
February 13, 2019
Sponsor
Instituto de Desarrollo e Investigaciones Pediátricas Prof. Dr. Fernando E. Viteri
1. Study Identification
Unique Protocol Identification Number
NCT03359447
Brief Title
Iron Deficiency Anemia, Iron Supplementation and Genomic Stability in Infants
Official Title
Effectiveness of Weekly and Daily Iron Supplementation for the Prevention of Iron-deficiency Anemia in Infants. Impact on Genomic Stability
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
March 2019 (Anticipated)
Study Completion Date
August 1, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto de Desarrollo e Investigaciones Pediátricas Prof. Dr. Fernando E. Viteri
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia, Iron-deficiency
Keywords
infant, primary prevention
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
InvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
204 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Weekly Iron
Arm Type
Experimental
Arm Description
Weekly ferrous sulfate: one dose (4mg/kg/week).
Arm Title
Daily Iron
Arm Type
Active Comparator
Arm Description
Daily ferrous sulfate: one dose (1 mg/kg/day). Maximum daily dose: 40 mg
Intervention Type
Drug
Intervention Name(s)
Weekly Ferrous Sulfate
Other Intervention Name(s)
Fer-in-sol
Intervention Description
Drops
Intervention Type
Drug
Intervention Name(s)
Daily Ferrous Sulfate
Other Intervention Name(s)
Fer-in-sol
Intervention Description
Drops
Primary Outcome Measure Information:
Title
Anemia
Description
Hemoglobin <11.0 g/dL in 6 months old infants.
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Iron deficiency
Description
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
Title
Adverse effects
Description
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
Title
Genomic Instability
Description
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
Title
Adherence
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
3 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Enrique Martins, Biochemist
Phone
540221155444457
Email
enriqueflmartins@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ana Varea, Biochemist
Phone
540221155411502
Email
anamvarea@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ana Varea, Biochemist
Organizational Affiliation
Instituto de Desarrollo e Investigaciones Pediátricas Prof. Dr. Fernando E. Viteri
Official's Role
Study Director
Facility Information:
Facility Name
Instituto de Desarrollo e Investigaciones Pediátricas Prof. Dr. Fernando E. Viteri
City
La Plata
State/Province
Buenos Aires
ZIP/Postal Code
1900
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Enrique Martins, Biochemist
Phone
540221155444457
Email
enriqueflmartins@gmail.com
First Name & Middle Initial & Last Name & Degree
Ana Varea, Biochemist
Phone
540221155411502
Email
anamvarea@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Learn more about this trial
Iron Deficiency Anemia, Iron Supplementation and Genomic Stability in Infants
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