Absorption of Iron From Stabilized Lactoferrin: A Study in Women With Iron Deficiency (NCT07394972) | Clinical Trial Compass
RecruitingNot Applicable
Absorption of Iron From Stabilized Lactoferrin: A Study in Women With Iron Deficiency
Switzerland45 participantsStarted 2026-02-17
Plain-language 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.
Who can participate
Age range
18 Years – 45 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.