Iron DeficiencyBFe01B1NCT00760890
Iron and the Breast-Fed Infant: Iron Status and Two Regimens of Iron Supplementation
A study testing Fer-In-Sol (ferrous sulfate) and Iron fortified cereal in people with Iron Deficiency, run by National Institutes of Health (NIH) at 1 site in United States.
Trial summary
Normal breastfed infants can develop iron deficiency by 6 months of age. This trial tested the hypothesis that regular provision of a source of iron beginning at 4 months of age improves iron status and could prevent iron deficiency. This was a prospective randomized trial involving breastfed infants. Read more about this study
- Who is it for?
- Ages 1 month to 24 monthsHealthy volunteers can take part
- Conditions the study is for
- Iron Deficiency
- What is being tested?
- Fer-In-Sol (ferrous sulfate) and Iron fortified cereal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 171 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2001to Oct 2005
- Phase
- Interventional
- 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 1 month to 24 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Predominantly breastfed (at 4 months) term infants
Who cannot join
- Not predominantly breastfed at 4 months
- Premature infants
Trial locations and contacts
1 site in 1 country.
About this study
Normal breastfed infants can develop iron deficiency by 6 months of age. This trial tested the hypothesis that regular provision of a source of iron beginning at 4 months of age improves iron status and could prevent iron deficiency. This was a prospective randomized trial involving breastfed infants. To be eligible, infants had to be predominantly breastfed (<200 ml/day of formula) at 4 months of age. At 4 months infants were randomly assigned to one of two interventions or to control. The interventions consisted in the daily administration of medicinal iron in a dose of 7.5 mg (Medicinal Iron Group) or in the daily feeding of one jar of an iron-fortified cereal providing 7 mg of iron each day (Cereal Group). The control group received complementary foods chosen by he parents but no source of iron provided by the investigators. The interventions took place from 4 to 9 months. All infants were subsequently followed to 2 years of age.
- Conditions
- Iron Deficiency
- Being tested
- Fer-In-Sol (ferrous sulfate), Iron fortified cereal
- Keywords
- Iron, breastfed infant
- Medical subject headings
- Iron Deficiencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fer-In-Sol (ferrous sulfate)Dietary supplement
7.5 mg/day in the form of 0.3 ml once each day
Iron fortified cerealDietary supplement
1 jar each day of one of three wet pack cereals manufactured by the Gerber Company: Each jar provided 7 mg of ferrous sulfate.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Medicinal Iron Receives: Dietary Supplement: Fer-In-Sol (ferrous sulfate) |
| B | Experimental | Iron fortified wet pack cereal Receives: Dietary Supplement: Iron fortified cereal |
| C | No intervention | Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Iron status
Measured: 3 times during the intervention
Secondary outcomes (2)
Growth
Measured: At the end of intervention
Tolerance (gastrointestinal)
Measured: During intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2008 (estimated)
- Study startJun 2001
- Primary completionJun 2005
- Study completionOct 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 171 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institutes of Health (NIH)
- Sponsor type
- US National Institutes of Health
- Investigators
- Ekhard E Ziegler, M.D., Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00760890
- Sponsor's protocol ID
- R01HD040315
- Acronym
- BFe01B1
- Status last verified
- Sep 2008
- First submitted
- 25 Sep 2008
- Last updated
- 26 Sep 2008
- Results posted
- No
Publications
Ziegler EE, Nelson SE, Jeter JM. Iron status of breastfed infants is improved equally by medicinal iron and iron-fortified cereal. Am J Clin Nutr. 2009 Jul;90(1):76-87. doi: 10.3945/ajcn.2008.27350. Epub 2009 May 20.
PubMed 19458014
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iron and the Breast-Fed Infant: Iron Status and Two Regimens of Iron Supplementation
- ClinicalTrials.gov ID
- NCT00760890
- Acronym / sponsor ID
- BFe01B1 / R01HD040315
- Conditions
- Iron Deficiency
- Keywords
- Iron, breastfed infant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 171 participants (actual)
- Lead sponsor
- National Institutes of Health (NIH)US National Institutes of Health
- Study start
- Jun 2001
- Primary completion
- Jun 2005 (actual)
- Study completion
- Oct 2005 (actual)
- First posted
- 26 Sep 2008 (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.
Normal breastfed infants can develop iron deficiency by 6 months of age. This trial tested the hypothesis that regular provision of a source of iron beginning at 4 months of age improves iron status and could prevent iron deficiency. This was a prospective randomized trial involving breastfed infants. To be eligible, infants had to be predominantly breastfed (<200 ml/day of formula) at 4 months of age. At 4 months infants were randomly assigned to one of two interventions or to control. The interventions consisted in the daily administration of medicinal iron in a dose of 7.5 mg (Medicinal Iron Group) or in the daily feeding of one jar of an iron-fortified cereal providing 7 mg of iron each day (Cereal Group). The control group received complementary foods chosen by he parents but no source of iron provided by the investigators. The interventions took place from 4 to 9 months. All infants were subsequently followed to 2 years of age.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Dietary Supplement: Fer-In-Sol (ferrous sulfate)Medicinal Iron |
| B | Experimental | Dietary Supplement: Iron fortified cerealIron fortified wet pack cereal |
| C | No intervention | –Control |
Who may qualify
- Ages
- 1 month to 24 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Predominantly breastfed (at 4 months) term infants
Key exclusion criteria (2 listed)
- Not predominantly breastfed at 4 months
- Premature infants
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-Sol (ferrous sulfate)7.5 mg/day in the form of 0.3 ml once each day | Dietary supplement | A |
| Iron fortified cereal1 jar each day of one of three wet pack cereals manufactured by the Gerber Company: Each jar provided 7 mg of ferrous sulfate. | Dietary supplement | B |
Primary outcome
Iron status
Time frame: 3 times during the intervention
2 secondary outcomes
Growth
Time frame: At the end of intervention
Tolerance (gastrointestinal)
Time frame: During intervention
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 26 Sep 2008.
- Derived from this study: PubMed 19458014Ziegler EE, Nelson SE, Jeter JM. Iron status of breastfed infants is improved equally by medicinal iron and iron-fortified cereal. Am J Clin Nutr. 2009 Jul;90(1):76-87. doi: 10.3945/ajcn.2008.27350. Epub 2009 May 20.
Related trials for Iron Deficiency
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Recruiting
Iron Absorption From a Nutritional Iron Supplement
Iron Absorption, Iron Deficiencies
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life
Heart Failure With Preserved Ejection Fraction, Iron Deficiencies
Recruiting
The Effects of Iron Treatment on Vaccine Immunogenicity in Kenyan Infants With Iron Deficiency
Iron Deficiencies
RecruitingPhase 4
The Effects of Low-Dose Versus High-Dose Intravenous IRON Therapy With Ferric DerisomaltOSE in Patients With Chronic Heart Failure and Iron Deficiency
Heart Failure, Iron Deficiency
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 E Ziegler, M.D. 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 study testing Fer-In-Sol (ferrous sulfate) and Iron fortified cereal in people with Iron Deficiency, run by National Institutes of Health (NIH) 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 1 inclusion and 2 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 26 Sep 2008. 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.
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 status (time frame: 3 times during the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00760890, which also lists 1 linked publication.
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 26 Sep 2008.