AnemiaPhase 4NCT03359447
Iron Deficiency Anemia, Iron Supplementation and Genomic Stability in Infants
A Phase 4 study testing Weekly Ferrous Sulfate and Daily Ferrous Sulfate in people with Anemia and Iron-deficiency, run by Instituto de Desarrollo e Investigaciones Pediátricas Prof. Dr. Fernando E. Viteri at 1 site in Argentina.
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. Read more about this study
- Who is it for?
- Ages 3 to 3 monthsHealthy volunteers can take part
- Conditions the study is for
- Anemia, Iron-deficiency
- What is being tested?
- Weekly Ferrous Sulfate and Daily Ferrous Sulfate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 1 siteArgentina
- Study dates
- 1 Aug 2017to 1 Aug 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 3 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Argentina1 site, 1 recruiting
- Recruiting
Instituto de Desarrollo e Investigaciones Pediátricas Prof. Dr. Fernando E. Viteri
La Plata, Buenos Aires, 1900
Enrique Martins, Biochemist, 540221155444457, enriqueflmartins@gmail.com
Ana Varea, Biochemist, 540221155411502, anamvarea@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Anemia, Iron-deficiency
- Being tested
- Weekly Ferrous Sulfate, Daily Ferrous Sulfate
- Keywords
- infant, primary prevention
- Medical subject headings
- Anemia, Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weekly Ferrous SulfateDrug
Also called Fer-in-sol
Drops
Daily Ferrous SulfateDrug
Also called Fer-in-sol
Drops
| Study group | Role | What they receive |
|---|---|---|
| Weekly Iron | Experimental | Weekly ferrous sulfate: one dose (4mg/kg/week). Receives: Drug: Weekly Ferrous Sulfate |
| Daily Iron | Active comparator | Daily ferrous sulfate: one dose (1 mg/kg/day). Maximum daily dose: 40 mg Receives: Drug: Daily Ferrous Sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anemia
Hemoglobin <11.0 g/dL in 6 months old infants.
Measured: 7 days
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2017
- Study start1 Aug 2017
- Primary completionMar 2019 (estimated)
- Study completion1 Aug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 204 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Desarrollo e Investigaciones Pediátricas Prof. Dr. Fernando E. Viteri
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ana Varea, Biochemist, Study director, Instituto de Desarrollo e Investigaciones Pediátricas Prof. Dr. Fernando E. Viteri
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03359447
- Sponsor's protocol ID
- 20070773
- Status last verified
- Feb 2019
- First submitted
- 13 Nov 2017
- Last updated
- 15 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Weekly and Daily Iron Supplementation for the Prevention of Iron-deficiency Anemia in Infants. Impact on Genomic Stability
- ClinicalTrials.gov ID
- NCT03359447
- Acronym / sponsor ID
- 20070773
- Conditions
- Anemia, Iron-deficiency
- Keywords
- infant, primary prevention
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 204 participants (estimated)
- Lead sponsor
- Instituto de Desarrollo e Investigaciones Pediátricas Prof. Dr. Fernando E. ViteriUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- Mar 2019 (estimated)
- Study completion
- 1 Aug 2019 (estimated)
- First posted
- 2 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Weekly Iron | Experimental | Drug: Weekly Ferrous SulfateWeekly ferrous sulfate: one dose (4mg/kg/week). |
| Daily Iron | Active comparator | Drug: Daily Ferrous SulfateDaily ferrous sulfate: one dose (1 mg/kg/day). Maximum daily dose: 40 mg |
Who may qualify
- Ages
- 3 to 3 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Weekly Ferrous SulfateAlso: Fer-in-solDrops | Drug | Weekly Iron |
| Daily Ferrous SulfateAlso: Fer-in-solDrops | Drug | Daily Iron |
Primary outcome
Anemia
Time frame: 7 days
Hemoglobin <11.0 g/dL in 6 months old infants.
4 secondary outcomes
Iron deficiency
Time frame: 7 days
Adverse effects
Time frame: Through study completion, an average of 1 year
Genomic Instability
Time frame: 15 days
Adherence
Time frame: Through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ana Varea, Biochemist study director
Instituto de Desarrollo e Investigaciones Pediátricas Prof. Dr. Fernando E. Viteri
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Weekly Ferrous Sulfate and Daily Ferrous Sulfate in people with Anemia and Iron-deficiency, run by Instituto de Desarrollo e Investigaciones Pediátricas Prof. Dr. Fernando E. Viteri at 1 site in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Enrique Martins, Biochemist (540221155444457, enriqueflmartins@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anemia (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2019; AzTrials last refreshed its copy on 7 Nov 2026.