Iron DeficiencyPhase 4NCT01444261
Prevention of Iron Deficiency in Breastfed Infants
A Phase 4 study testing Fer-in-Sol in people with Iron Deficiency and Anemia, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.
Trial summary
With early screening and appropriate iron supplementation, iron deficiency in the first year of life can be prevented in breastfed infants. Read more about this study
- Who is it for?
- Ages 4 weeks to 9 monthsHealthy volunteers can take part
- Conditions the study is for
- Iron Deficiency, Anemia
- What is being tested?
- Fer-in-Sol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 219 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2010to Apr 2014
- 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 4 weeks to 9 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Term infants
- gestational age 37-42 weeks
- birth weight > 2500 g
- exclusively breastfed at 28 d of age
- intend to breast feed until 9 mo of age
Who cannot join
- supplemental formula before 4 mo of age
Trial locations and contacts
1 site in 1 country.
About this study
With early screening and appropriate iron supplementation, iron deficiency in the first year of life can be prevented in breastfed infants.
Read the detailed description
Infants with low ferritin at 1 month are at high risk of iron deficiency. They will receive iron drops starting at 2 months. All other infants are at low risk of iron deficiency. All infants will receive iron-fortified cereal starting at 4 months of age.
- Conditions
- Iron Deficiency, Anemia
- Being tested
- Fer-in-Sol, control
- Keywords
- iron deficiency, anemia
- Medical subject headings
- Iron Deficiencies, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fer-in-SolDietary supplement
Fer-in-Sol drops providing 7.5 mg iron in 0.3 ml per day given from 84 to 168 d of age and iron-fortified cereal
controlOther
No dietary supplements
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | Fer-in-Sol drops and iron-fortified cereal Receives: Dietary Supplement: Fer-in-Sol |
| Control | Other | No intervention Receives: Other: control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Iron deficiency anemia will be prevented in all infants before 5.5 mo of age
Iron deficiency anemia will be defined as plasma ferritin less than 10 ug/L and hemoglobin less than 105 g/L. The expected outcome is there will be no infants with iron deficiency anemia before 5.5 mo of age.
Measured: 5.5 mo
Secondary outcomes (1)
Determine the number of infants with iron deficiency between 5.5 and 9 mo of age
Iron deficiency will be determined as plasma ferritin less than 10 ug/L. We will determine the number of infants with iron deficiency between 5.5 and 9 mo of age
Measured: 9 mo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2011 (estimated)
- Study startDec 2010
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron DeficiencyStudies 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
- Masking
- None (open label)
- Enrolment
- 219 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
- Collaborators
- University of Iowa
- Responsible party
- Principal investigator, Ekhard Ziegler, University of Iowa
- Investigators
- Ekhard Ziegler, MD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01444261
- Sponsor's protocol ID
- BFe10D
- Status last verified
- Mar 2017
- First submitted
- 28 Sep 2011
- Last updated
- 31 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Iron Deficiency in Breastfed Infants
- ClinicalTrials.gov ID
- NCT01444261
- Acronym / sponsor ID
- BFe10D
- Conditions
- Iron Deficiency, Anemia
- Keywords
- iron deficiency, anemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 219 participants (actual)
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Collaborators
- University of Iowa
- Study start
- Dec 2010
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 30 Sep 2011 (estimated)
- 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.
With early screening and appropriate iron supplementation, iron deficiency in the first year of life can be prevented in breastfed infants.
Detailed description
Infants with low ferritin at 1 month are at high risk of iron deficiency. They will receive iron drops starting at 2 months. All other infants are at low risk of iron deficiency. All infants will receive iron-fortified cereal starting at 4 months of age.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Dietary Supplement: Fer-in-SolFer-in-Sol drops and iron-fortified cereal |
| Control | Other | Other: controlNo intervention |
Who may qualify
- Ages
- 4 weeks to 9 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Term infants
- gestational age 37-42 weeks
- birth weight > 2500 g
- exclusively breastfed at 28 d of age
- intend to breast feed until 9 mo of age
Key exclusion criteria (1 listed)
- supplemental formula before 4 mo of age
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 |
|---|---|---|
| Fer-in-SolFer-in-Sol drops providing 7.5 mg iron in 0.3 ml per day given from 84 to 168 d of age and iron-fortified cereal | Dietary supplement | Intervention |
| controlNo dietary supplements | Other | Control |
Primary outcome
Iron deficiency anemia will be prevented in all infants before 5.5 mo of age
Time frame: 5.5 mo
Iron deficiency anemia will be defined as plasma ferritin less than 10 ug/L and hemoglobin less than 105 g/L. The expected outcome is there will be no infants with iron deficiency anemia before 5.5 mo of age.
1 secondary outcome
Determine the number of infants with iron deficiency between 5.5 and 9 mo of age
Time frame: 9 mo
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2017.
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The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life
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Iron Deficiencies
RecruitingPhase 4
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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.
Ekhard Ziegler, MD principal investigator
University of Iowa
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 Fer-in-Sol in people with Iron Deficiency and Anemia, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.
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 5 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: finished, as of the sponsor's last update on 31 Mar 2017. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Iron deficiency anemia will be prevented in all infants before 5.5 mo of age (time frame: 5.5 mo). 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 31 Mar 2017.