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Mineral Supplement
Iron Supplementation for Infant Gut Development (IF Trial)
N/A
Recruiting
Led By Minghua Tang, PhD
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up birth to 4 months of age
Awards & highlights
IF Trial Summary
This trial will study whether high iron in infant formula affects gut development. Infants will be given either high or low iron formula from birth until 4 months, and blood and stool samples will be collected to measure the effects of the iron exposure.
Who is the study for?
This trial is for healthy newborn infants whose mothers plan to formula feed. Infants who cannot consume cow-milk based formula are not eligible to participate.Check my eligibility
What is being tested?
The study compares the effects of high iron versus low iron in infant formula on gut development. From birth until 4 months, enrolled infants will receive either high or low iron formula, with blood and stool samples taken at start and end to assess impact.See study design
What are the potential side effects?
While specific side effects are not detailed, monitoring will include observing any potential changes in the infants' gut microbiome, sleep patterns, and overall iron status due to varying levels of iron in their formula.
IF Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ birth to 4 months of age
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~birth to 4 months of age
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Gut microbiota
Secondary outcome measures
Immunity: soluble CD14
Inflammation: c-reactive protein
Iron status: ferritin
+3 moreIF Trial Design
2Treatment groups
Experimental Treatment
Group I: Standard iron armExperimental Treatment1 Intervention
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
Group II: Low iron armExperimental Treatment1 Intervention
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
Find a Location
Who is running the clinical trial?
University of Colorado, DenverLead Sponsor
1,738 Previous Clinical Trials
2,149,496 Total Patients Enrolled
1 Trials studying Infant Development
152 Patients Enrolled for Infant Development
Minghua Tang, PhDPrincipal InvestigatorUniversity of Colorado, Denver
3 Previous Clinical Trials
327 Total Patients Enrolled
1 Trials studying Infant Development
152 Patients Enrolled for Infant Development
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My newborn is healthy.My newborn cannot consume cow-milk based formula due to their condition.
Research Study Groups:
This trial has the following groups:- Group 1: Standard iron arm
- Group 2: Low iron arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are adults above the age of eighteen permitted to enroll in this experimental trial?
"This trial is seeking out infants who are between 1 Day and 4 Months old."
Answered by AI
Is it possible to join the research project?
"This medical trial seeks 30 infants aged between 1 day and 4 months, who have standard healthy development."
Answered by AI
Is this research project currently looking for participants?
"According to the clinicaltrials.gov portal, this research effort is seeking participants and was originally posted on September 28th 2021 with its most recent update occurring a day later."
Answered by AI
What is the maximum enrollment threshold for this research project?
"Affirmative. As per the clinicaltrials.gov listing, this medical trial is currently enrolling participants and was initially posted on September 28th 2021 with a modification being made one day later. The study mandates 30 patients to be recruited from 1 centre of care."
Answered by AI
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