Infant DevelopmentIFNCT03828708
Early Iron Exposure on the Gut Microbiota in Young Infants
A study testing Iron in infant formula in people with Infant Development, run by University of Colorado, Denver at 1 site in United States.
Trial summary
This study will look at the amount of iron in infant formula and how that affects a child's gut development. The children of mothers who plan to formula feed their children will be randomized to receive either high iron or low iron formula from birth until 4 months of age. Read more about this study
- Who is it for?
- Ages 1 day to 4 monthsHealthy volunteers can take part
- Conditions the study is for
- Infant Development
- What is being tested?
- Iron in infant formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Sep 2021to May 2024
- 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 day to 4 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy new born infants
Who cannot join
- Newborn infants with conditions that prohibit cow-milk based formula consumption
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
Minghua Tang, PhD, 303-724-3248, minghua.tang@ucdenver.edu
About this study
Official title: Different Iron Exposure on the Development of Gut Microbiota From Birth to Four Months
This study will look at the amount of iron in infant formula and how that affects a child's gut development. The children of mothers who plan to formula feed their children will be randomized to receive either high iron or low iron formula from birth until 4 months of age. Infants will consume only the study provided formula during enrollment. Blood and stool samples will be collected at birth and end of study to measure the effects of the iron exposure. The overall object is to compare high iron versus low iron exposure in formula-fed infants during the first months of life. Aims include determining the types of bacteria that are present in the infants' fecal microbiome, determining the effect of high iron exposure on gut microbiome and sleep patterns, and comparing iron status and homeostasis between the low and high iron formula groups.
Read the detailed description
Disturbance of the gut microbial colonization during infancy may result in long-term programming impact of metabolism and disease risks of the host. The early gut microbial colonization coincides with the maturation of the infant's mucosal innate immune system and research showed that the gut microbial dysbiosis is associated with impaired innate immune development. Thus, ensuring proper microbial colonization early in life is critical to the maturation of the immune system and long-term health.
Iron fortification can increase the abundance of pathogenic bacteria and induce inflammation in older infants. However, it is still not known what the effect of iron is on a more vulnerable population: the newborn infant, who has immature immune system. Infants 0-4 months are at a low risk for iron deficiency due to the iron endowment at birth, which is compatible with the very low iron content (<0.5mg Fe/L) in breastmilk. However, commercial infant formulas are all fortified with ≥12mg Fe/L. Whether this striking difference drives adverse health effects is unknown/unexamined, especially on early colonization and immune homeostasis. The overall objective is to determine the impact of high vs. low iron exposure in formula-fed infants during the early post-natal months on gut microbiome.
- Conditions
- Infant Development
- Being tested
- Iron in infant formula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iron in infant formulaOther
Participants will receive the same low-iron (5 mg/L) infant formula. Infants in the standard iron group will add iron supplement to pre-made infant formula so the iron content will be 12 mg/L.
| Study group | Role | What they receive |
|---|---|---|
| Standard iron arm | Experimental | Participants randomized to this arm will consume infant formula containing 12 mg/L of iron, equivalent to the standard iron content in U.S. infant formula Receives: Other: Iron in infant formula |
| Low iron arm | Experimental | Participants randomized to this arm will consume infant formula containing 5 mg/L of iron, equivalent to the standard iron content in European infant formula Receives: Other: Iron in infant formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gut microbiota
the gut microbial structure of the participants, by stool samples collected
Measured: birth to 4 months of age
Secondary outcomes (6)
Iron status: soluble transferrin receptor
Soluble transferrin receptors are proteins found in blood that can be elevated with iron deficiency.
Measured: at baseline (birth) and end of intervention (4 months)
Iron status: ferritin
A ferritin blood test shows how much iron is stored in your body.
Measured: at baseline (birth) and end of intervention (4 months)
Iron status: hepcidin
Hepcidin is a regulator of iron metabolism.
Measured: at baseline (birth) and end of intervention (4 months)
Inflammation: c-reactive protein
C-reactive protein (CRP) is a substance produced by the liver in response to inflammation.
Measured: at baseline (birth) and end of intervention (4 months)
Immunity: soluble CD14
biomarker of innate immunity
Measured: at baseline (birth) and end of intervention (4 months)
Sleep patterns: duration
Participants will wear a device (Micro Motionlogger Watch version 734) to provide objective measurements of duration.
Measured: end of intervention (4 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2019
- Study start28 Sep 2021
- Primary completionMay 2024 (estimated)
- Study completionMay 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant DevelopmentStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Model description
- Participants will be randomized to one of the two groups with different amount of iron consumed.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Minghua Tang, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03828708
- Sponsor's protocol ID
- 18-1317
- Acronym
- IF
- Status last verified
- Feb 2023
- First submitted
- 30 Jan 2019
- Last updated
- 2 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: the gut microbiome sequencing data will be shared
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Different Iron Exposure on the Development of Gut Microbiota From Birth to Four Months
- ClinicalTrials.gov ID
- NCT03828708
- Acronym / sponsor ID
- IF / 18-1317
- Conditions
- Infant Development
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 28 Sep 2021 (actual)
- Primary completion
- May 2024 (estimated)
- Study completion
- May 2024 (estimated)
- First posted
- 4 Feb 2019 (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 will look at the amount of iron in infant formula and how that affects a child's gut development. The children of mothers who plan to formula feed their children will be randomized to receive either high iron or low iron formula from birth until 4 months of age. Infants will consume only the study provided formula during enrollment. Blood and stool samples will be collected at birth and end of study to measure the effects of the iron exposure. The overall object is to compare high iron versus low iron exposure in formula-fed infants during the first months of life. Aims include determining the types of bacteria that are present in the infants' fecal microbiome, determining the effect of high iron exposure on gut microbiome and sleep patterns, and comparing iron status and homeostasis between the low and high iron formula groups.
Detailed description
Disturbance of the gut microbial colonization during infancy may result in long-term programming impact of metabolism and disease risks of the host. The early gut microbial colonization coincides with the maturation of the infant's mucosal innate immune system and research showed that the gut microbial dysbiosis is associated with impaired innate immune development. Thus, ensuring proper microbial colonization early in life is critical to the maturation of the immune system and long-term health.
Iron fortification can increase the abundance of pathogenic bacteria and induce inflammation in older infants. However, it is still not known what the effect of iron is on a more vulnerable population: the newborn infant, who has immature immune system. Infants 0-4 months are at a low risk for iron deficiency due to the iron endowment at birth, which is compatible with the very low iron content (<0.5mg Fe/L) in breastmilk. However, commercial infant formulas are all fortified with ≥12mg Fe/L. Whether this striking difference drives adverse health effects is unknown/unexamined, especially on early colonization and immune homeostasis. The overall objective is to determine the impact of high vs. low iron exposure in formula-fed infants during the early post-natal months on gut microbiome.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized to one of the two groups with different amount of iron consumed.
| Arm | Type | Receives |
|---|---|---|
| Standard iron arm | Experimental | Other: Iron in infant formulaParticipants randomized to this arm will consume infant formula containing 12 mg/L of iron, equivalent to the standard iron content in U.S. infant formula |
| Low iron arm | Experimental | Other: Iron in infant formulaParticipants randomized to this arm will consume infant formula containing 5 mg/L of iron, equivalent to the standard iron content in European infant formula |
Who may qualify
- Ages
- 1 day to 4 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Healthy new born infants
Key exclusion criteria (1 listed)
- Newborn infants with conditions that prohibit cow-milk based formula consumption
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 |
|---|---|---|
| Iron in infant formulaParticipants will receive the same low-iron (5 mg/L) infant formula. Infants in the standard iron group will add iron supplement to pre-made infant formula so the iron content will be 12 mg/L. | Other | Low iron arm, Standard iron arm |
Primary outcome
Gut microbiota
Time frame: birth to 4 months of age
the gut microbial structure of the participants, by stool samples collected
6 secondary outcomes
Iron status: soluble transferrin receptor
Time frame: at baseline (birth) and end of intervention (4 months)
Iron status: ferritin
Time frame: at baseline (birth) and end of intervention (4 months)
Iron status: hepcidin
Time frame: at baseline (birth) and end of intervention (4 months)
Inflammation: c-reactive protein
Time frame: at baseline (birth) and end of intervention (4 months)
Immunity: soluble CD14
Time frame: at baseline (birth) and end of intervention (4 months)
Sleep patterns: duration
Time frame: end of intervention (4 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2023.
- Individual participant dataSharing planned: Undecided. the gut microbiome sequencing data will be shared
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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.
Minghua Tang, PhD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Iron in infant formula in people with Infant Development, run by University of Colorado, Denver 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 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 2 Feb 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Minghua Tang, PhD (7653377572, minghua.tang@ucdenver.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gut microbiota (time frame: birth to 4 months of age). 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 2 Feb 2023.