NCT07394972 Absorption of Iron From Stabilized Lactoferrin: A Study in Women With Iron Deficiency
| NCT ID | NCT07394972 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Nicole Stoffel |
| Condition | Iron Deficiency (Without Anemia) |
| Study Type | INTERVENTIONAL |
| Enrollment | 45 participants |
| Start Date | 2026-02-17 |
| Primary Completion | 2026-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 45 participants in total. It began in 2026-02-17 with a primary completion date of 2026-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Lactoferrin (LF) is a natural iron-binding protein found in milk. It exists either in an iron-free state (apo-LF) or bound to iron (holo-LF). Whether LF binds iron to facilitate its absorption and/or to sequester iron from potential enteropathogens remains uncertain. However, while LF is a promising tool for treating iron deficiency, it is sensitive to heat during food processing and to the acidic environment of the human stomach. This degradation often causes LF to lose its functional properties before it can promote iron absorption effectively. This study aims to evaluate whether encapsulating apo-LF (either alone or in combination with iron) can protect LF from digestion and enhance iron absorption. Using a randomized, crossover design, different encapsulation methods will be compared to determine which results in the highest iron absorption in women with iron deficiency. All test compounds will be labeled with stable iron isotopes. Participants will consume the labeled compounds with a test meal or water in a randomized order, allowing for within subject comparisons. Fractional iron absorption will be measured 17 days after administration via the incorporation of labeled iron into red blood cells.
Eligibility Criteria
Inclusion Criteria: * Serum ferritin \< 45 µg/L (iron depleted) * Body weight \< 70 kg * Body mass index 18,5 - 24,9 kg/m2 (normal weight) * Hemoglobin (Hb) \> 120 g/L (nonanemic) * C-reactive protein (CRP) \< 5 mg/L (no inflammation) Exclusion Criteria: * Pregnant or lactating * Strictly vegan * Cigarette smoking (\> 1 cigarette / week) * Gastrointestinal or metabolic disorders affecting iron absorption or metabolism * Use of medication known to affect iron metabolism (oral contraceptives are allowed) * Intake of vitamin and mineral supplements in the 2 weeks before study start and during the study * Blood transfusion, blood donation, or significant blood loss during the previous 4 months * once enrolled, inability to follow study procedures or major illness * Participation in another study with investigational drug within the 30 days preceding and during the present study
Contact & Investigator
Nicole Ursula Stoffel, Prof.
PRINCIPAL INVESTIGATOR
ETH Zurich
Frequently Asked Questions
Who can join the NCT07394972 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 45 Years, studying Iron Deficiency (Without Anemia). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07394972 currently recruiting?
Yes, NCT07394972 is actively recruiting participants. Contact the research team at lobsterstudy@pharma.ethz.ch for enrollment information.
Where is the NCT07394972 trial being conducted?
This trial is being conducted at Zurich, Switzerland.
Who is sponsoring the NCT07394972 clinical trial?
NCT07394972 is sponsored by Nicole Stoffel. The principal investigator is Nicole Ursula Stoffel, Prof. at ETH Zurich. The trial plans to enroll 45 participants.