Iron DeficiencyBfe03BNCT00841061
Cereals as a Source of Iron for Breastfed Infants
A study testing electrolytic iron and ferrous fumarate in people with Iron Deficiency, run by National Institutes of Health (NIH) at 1 site in United States.
Trial summary
The purpose of this research study is to determine whether the type of iron in infant cereals makes a differance in how well the cereal helps infants remain free of iron deficiency. Read more about this study
- Who is it for?
- Ages 28 days to 1 yearHealthy volunteers can take part
- Conditions the study is for
- Iron Deficiency
- What is being tested?
- electrolytic iron and ferrous fumarate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2003to May 2006
- 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 28 days to 1 year
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- exclusively breastfed
- birth weight between 2500 and 4200g
- gestational age >36 weeks
Who cannot join
- supplementing formula
- no iron drops
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Breast Feeding and Iron: Comparison of Cereals Fortified With Different Forms of Iron
The purpose of this research study is to determine whether the type of iron in infant cereals makes a differance in how well the cereal helps infants remain free of iron deficiency.
- Conditions
- Iron Deficiency
- Being tested
- electrolytic iron, ferrous fumarate
- Medical subject headings
- Iron Deficiencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electrolytic ironDietary supplement
1/4 a cup of cereal fortified with electrolytic iron per day between the ages of 112 days and 280 days of age
ferrous fumarateDietary supplement
1/4 cup of cereal fortified with ferrous fumarate to be fed per day between ages of 112 days and 280 days of age
| Study group | Role | What they receive |
|---|---|---|
| Cereal L | Active comparator | Rice cereal with electrolytic iron Receives: Dietary Supplement: electrolytic iron |
| Cereal M | Active comparator | Rice cereal with ferrous fumarate Receives: Dietary Supplement: ferrous fumarate |
What is being measured
The primary outcome is the main question the study is designed to answer.
plasma ferritin
Measured: 280 days
Secondary outcomes (1)
hemoglobin
Measured: 280
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2009 (estimated)
- Study startJul 2003
- Primary completionMay 2006
- Study completionMay 2006
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institutes of Health (NIH)
- Sponsor type
- US National Institutes of Health
- Investigators
- Ekhard E Ziegler, MD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00841061
- Sponsor's protocol ID
- B530500
- Other IDs
- HD40315-01
- Acronym
- Bfe03B
- Status last verified
- Jan 2009
- First submitted
- 9 Feb 2009
- Last updated
- 11 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Ziegler EE, Fomon SJ, Nelson SE, Jeter JM, Theuer RC. Dry cereals fortified with electrolytic iron or ferrous fumarate are equally effective in breast-fed infants. J Nutr. 2011 Feb;141(2):243-8. doi: 10.3945/jn.110.127266. Epub 2010 Dec 22.
PubMed 21178077
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breast Feeding and Iron: Comparison of Cereals Fortified With Different Forms of Iron
- ClinicalTrials.gov ID
- NCT00841061
- Acronym / sponsor ID
- Bfe03B / B530500
- Conditions
- Iron Deficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- National Institutes of Health (NIH)US National Institutes of Health
- Study start
- Jul 2003
- Primary completion
- May 2006 (actual)
- Study completion
- May 2006 (actual)
- First posted
- 11 Feb 2009 (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.
The purpose of this research study is to determine whether the type of iron in infant cereals makes a differance in how well the cereal helps infants remain free of iron deficiency.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cereal L | Active comparator | Dietary Supplement: electrolytic ironRice cereal with electrolytic iron |
| Cereal M | Active comparator | Dietary Supplement: ferrous fumarateRice cereal with ferrous fumarate |
Who may qualify
- Ages
- 28 days to 1 year
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- exclusively breastfed
- birth weight between 2500 and 4200g
- gestational age >36 weeks
Key exclusion criteria (2 listed)
- supplementing formula
- no iron drops
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 |
|---|---|---|
| electrolytic iron1/4 a cup of cereal fortified with electrolytic iron per day between the ages of 112 days and 280 days of age | Dietary supplement | Cereal L |
| ferrous fumarate1/4 cup of cereal fortified with ferrous fumarate to be fed per day between ages of 112 days and 280 days of age | Dietary supplement | Cereal M |
Primary outcome
plasma ferritin
Time frame: 280 days
1 secondary outcome
hemoglobin
Time frame: 280
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 11 Feb 2009.
- Derived from this study: PubMed 21178077Ziegler EE, Fomon SJ, Nelson SE, Jeter JM, Theuer RC. Dry cereals fortified with electrolytic iron or ferrous fumarate are equally effective in breast-fed infants. J Nutr. 2011 Feb;141(2):243-8. doi: 10.3945/jn.110.127266. Epub 2010 Dec 22.
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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 E 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 study testing electrolytic iron and ferrous fumarate 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 3 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 11 Feb 2009. 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?
plasma ferritin (time frame: 280 days). 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 NCT00841061, 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 11 Feb 2009.