InfantMJAUNCT01216709
Iron Absorption From Infant Formula and Iron Drops in Infants (MJAU-studien)
A study testing ferrous sulfate, iron-fortified infant formula (12.4 mg iron/L) and iron-fortified infant formula (2.3 mg iron/L) in people with Infant and Dietary Supplements, run by Umeå University at 1 site in Sweden.
Trial summary
Iron deficiency (ID) affects up to 25% of Swedish infants and severe ID is associated with cognitive and behavioral problems. To avoid this, iron supplements or iron-fortified infant foods are recommended for infants. However, the optimal iron dose and mode of delivery have not yet been established. Read more about this study
- Who is it for?
- Ages 6 to 7 monthsHealthy volunteers can take part
- Conditions the study is for
- Infant, Dietary Supplements, Food, Fortified
- What is being tested?
- ferrous sulfate, iron-fortified infant formula (12.4 mg iron/L) and iron-fortified infant formula (2.3 mg iron/L)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteSweden
- Study dates
- Oct 2010to Jun 2012
- 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 6 to 7 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 6-7 months of age at the start of intervention
- healthy at enrollment
- full-term (>37 gestational weeks at birth)
- birth weight >2500 g
- predominantly bottle-fed at recruitment
Who cannot join
- iron deficiency at enrollment
- previous or current use of iron supplements
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Clinical Sciences, Pediatrics, Umeå University Hospital
Umeå, 901 85
About this study
Official title: Iron Absorption From Iron-fortified Infant Formula and Iron Drops in Infants (MJAU-studien)
Iron deficiency (ID) affects up to 25% of Swedish infants and severe ID is associated with cognitive and behavioral problems. To avoid this, iron supplements or iron-fortified infant foods are recommended for infants. However, the optimal iron dose and mode of delivery have not yet been established. This is a concern as excessive iron intake may impair growth and increase morbidity in iron-sufficient infants. Previous studies have suggested that iron-fortified foods may have different effects than iron supplements. In this study, the investigators will investigate whether the mode of iron administration (supplementation vs. fortification) and the amount consumed (high intakes vs. low intakes) affect iron absorption, iron utilization, and zinc absorption in healthy term non-iron-deficient 6-month-old infants.
- Conditions
- Infant, Dietary Supplements, Food, Fortified
- Being tested
- ferrous sulfate, iron-fortified infant formula (12.4 mg iron/L), iron-fortified infant formula (2.3 mg iron/L)
- Keywords
- Infant, Dietary Supplements, Food, Fortified, Iron Absorption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ferrous sulfateDietary supplement
6.3 mg iron from iron drops and 0.3 mg iron from infant formula with no added iron (0.5 mg iron/L) for 45 days
iron-fortified infant formula (12.4 mg iron/L)Other
6.6 mg iron from iron-fortified infant formula (12.4 mg iron/L) for 45 days
iron-fortified infant formula (2.3 mg iron/L)Other
1.2 mg iron from iron-fortified infant formula (2.3 mg iron/L) for 45 days
| Study group | Role | What they receive |
|---|---|---|
| iron drops | Experimental | Not described Receives: Dietary Supplement: ferrous sulfate |
| iron-fortified formula (2.3 mg iron/L) | Experimental | Not described Receives: Other: iron-fortified infant formula (2.3 mg iron/L) |
| iron-fortified formula (12.4 mg iron /L) | Experimental | Not described Receives: Other: iron-fortified infant formula (12.4 mg iron/L) |
What is being measured
The primary outcome is the main question the study is designed to answer.
iron absorption
Measured: 1 month after enrollment
Secondary outcomes (2)
indicators of iron metabolism, growth, and oxidative stress
Measured: 1 month and 1.5 months after enrollment
zinc absorption
Measured: 1 month after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2010 (estimated)
- Study startOct 2010
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfantStudies of the same condition, open and under way.
- More trials run by Umeå UniversityThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss Federal Institute of Technology, University of California, Davis
- Responsible party
- Principal investigator, Magnus Domellöf, Umeå University
- Investigators
- Magnus Domellöf, MD, PhD, Principal investigator, Umeå University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01216709
- Sponsor's protocol ID
- Iron absorption in infants
- Acronym
- MJAU
- Status last verified
- Mar 2020
- First submitted
- 6 Oct 2010
- Last updated
- 26 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iron Absorption From Iron-fortified Infant Formula and Iron Drops in Infants (MJAU-studien)
- ClinicalTrials.gov ID
- NCT01216709
- Acronym / sponsor ID
- MJAU / Iron absorption in infants
- Conditions
- Infant, Dietary Supplements, Food, Fortified
- Keywords
- Infant, Dietary Supplements, Food, Fortified, Iron Absorption
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Collaborators
- Swiss Federal Institute of Technology, University of California, Davis
- Study start
- Oct 2010 (actual)
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 7 Oct 2010 (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.
Iron deficiency (ID) affects up to 25% of Swedish infants and severe ID is associated with cognitive and behavioral problems. To avoid this, iron supplements or iron-fortified infant foods are recommended for infants. However, the optimal iron dose and mode of delivery have not yet been established. This is a concern as excessive iron intake may impair growth and increase morbidity in iron-sufficient infants. Previous studies have suggested that iron-fortified foods may have different effects than iron supplements. In this study, the investigators will investigate whether the mode of iron administration (supplementation vs. fortification) and the amount consumed (high intakes vs. low intakes) affect iron absorption, iron utilization, and zinc absorption in healthy term non-iron-deficient 6-month-old infants.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| iron drops | Experimental | Dietary Supplement: ferrous sulfate |
| iron-fortified formula (2.3 mg iron/L) | Experimental | Other: iron-fortified infant formula (2.3 mg iron/L) |
| iron-fortified formula (12.4 mg iron /L) | Experimental | Other: iron-fortified infant formula (12.4 mg iron/L) |
Who may qualify
- Ages
- 6 to 7 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 6-7 months of age at the start of intervention
- healthy at enrollment
- full-term (>37 gestational weeks at birth)
- birth weight >2500 g
- predominantly bottle-fed at recruitment
Key exclusion criteria (2 listed)
- iron deficiency at enrollment
- previous or current use of iron 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 |
|---|---|---|
| ferrous sulfate6.3 mg iron from iron drops and 0.3 mg iron from infant formula with no added iron (0.5 mg iron/L) for 45 days | Dietary supplement | iron drops |
| iron-fortified infant formula (12.4 mg iron/L)6.6 mg iron from iron-fortified infant formula (12.4 mg iron/L) for 45 days | Other | iron-fortified formula (12.4 mg iron /L) |
| iron-fortified infant formula (2.3 mg iron/L)1.2 mg iron from iron-fortified infant formula (2.3 mg iron/L) for 45 days | Other | iron-fortified formula (2.3 mg iron/L) |
Primary outcome
iron absorption
Time frame: 1 month after enrollment
2 secondary outcomes
indicators of iron metabolism, growth, and oxidative stress
Time frame: 1 month and 1.5 months after enrollment
zinc absorption
Time frame: 1 month after enrollment
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 Mar 2020.
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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.
Magnus Domellöf, MD, PhD principal investigator
Umeå University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ferrous sulfate, iron-fortified infant formula (12.4 mg iron/L) and iron-fortified infant formula (2.3 mg iron/L) in people with Infant and Dietary Supplements, run by Umeå University at 1 site in Sweden.
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 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 Mar 2020. 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 Sweden. 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 absorption (time frame: 1 month after enrollment). 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 26 Mar 2020.