NCT07139821 · Pennington Biomedical Research Center
Dietary Iron Requirements
What this study is about
Dietary Reference Intakes (DRIs) for iron are based on a relatively small number of studies in European populations. This research study will determine iron needs in a representative sample of adults living in the US using the iron isotope dilution technique. Following administration and equilibration of a stable iron isotope, participants will be followed for a 12 week study period.
View original scientific description
Dietary Reference Intakes (DRIs) for iron are based on a relatively small number of studies in European populations. This research study will determine iron needs in a representative sample of adults living in the US using the iron isotope dilution technique. Following administration and equilibration of a stable iron isotope, participants will be followed for a 12 week study period. Blood will be collected every 4 weeks and the isotopic composition will be determined. Results will help update dietary iron guidelines making sure they better match the specific needs of the US population.
Interventions
OTHER
Stable iron isotope
Stable iron isotopes will be used to determine iron requirements.
Primary outcome measures
Iron isotope composition in blood
Time frame: 12 weeks
Tracer-to-tracee rate in venous blood samples collected at multiple time points
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Males and premenopausal females age 18-50 y
- Previously participated in an iron stable isotope study or willing to consume an oral stable iron isotope and undergo a one-year equilibration period
- Willing to refrain from iron-containing supplements for the duration of the study
- Willing to refrain from tobacco smoking for the duration of the study
- Have not donated blood 3 months prior to the start of the study and willing to refrain from donating blood for the duration of the study
- Willing to have blood stored for future use
- Able and willing to comply with study requirements and consent to participate
Exclusion criteria
- Females: pregnant or lactating or plans to become pregnant during the study period
- Inability to provide informed consent and engage in informed consent procedures
- Plans to relocate outside the study area
Where
- Baton Rouge, Louisiana
- Ithaca, New York
Collaborators
Cornell University
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 29, 2026 · Source of record for eligibility and locations