Study on how a new iron supplement is absorbed in women when taken in multiple doses
| ISRCTN | ISRCTN78497162 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN78497162 |
| Sponsor | Zambon (Italy) |
| Funder | Zambon Italia |
- Submission date
- 25/02/2026
- Registration date
- 02/03/2026
- Last edited
- 24/06/2026
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
In previous in-vitro studies, the product showed high iron bioaccessibility (95.99%) after simulated gastrointestinal digestion, and near-complete transepithelial iron permeation (98.87 ± 4.39%) after 4 hours in a validated intestinal cell model. The product also demonstrated good intestinal tolerability across a wide range of tested concentrations, along with antioxidant properties that may help reduce oxidative stress related to iron supplementation. These preclinical data provide a rationale for the clinical investigation as a well-tolerated and highly bioavailable oral iron formulation.
The aim of the study is to evaluate the bioavailability (i.e., the amount of iron that reaches the bloodstream) of a new iron-based dietary supplement formulation after single and multiple oral administration.
The study will also assess the safety and tolerability of the investigational product, as well as participants’ satisfaction with its intake.
Who can participate?
Healthy adult women, aged 18-60 years old inclusive, and those with mild iron deficiency .
What does the study involve?
The investigational product (i.e., one capsule of Monurelle® Ferro Naturale) will be administered once a day for 3 consecutive days. The investigational product will be orally administered in the morning, at 08:00±1 h, under fasting conditions, from Day 1 to Day 3. It will be swallowed (without chewing) by study participants with 150 mL of still mineral water at room temperature.
What are the possible benefits and risks of participating?
Participation in the study is not expected to provide any direct benefit; however, it may contribute to generating additional information on the investigational product that could be useful for future patients. Participants may indirectly benefit from the medical assessments performed free of charge during the course of the study. This is the first clinical study of this new iron formulation; therefore, specific safety and tolerability data in humans are not yet available. However, oral iron supplements are generally well tolerated when taken at appropriate doses. Given the low dosage administered in this study (30 mg once daily for three consecutive days), no particular risks are expected. Possible side effects may include metallic taste, gastrointestinal discomfort, constipation, diarrhea, nausea, and vomiting.
Where is the study run from?
The study was conducted at the CROSS Research S.A. Phase I Unit Clinical Centre, in Arzo (Switzerland)
When is the study starting and how long is it expected to run for?
February 2026 to May 2026
Who is funding the study?
Zambon S.p.A., Italy
Who is the main contact?
Dr Milko Radicioni, clinic@croalliance.com
Contact information
Public, Scientific
Via Lillo del Duca, 10
Bresso (MI)
20091
Italy
 ORCID ID |
0009-0002-9829-1477 |
|---|---|
| Phone | +39.346.26.42.844 |
| pietro.magrone@zambongroup.com |
Scientific, Principal investigator
Via F.A. Giorgioli, 14
Arzo
6864
Switzerland
| ORCID ID |
0000-0002-3940-8375 |
|---|---|
| Phone | +41 (0)91 64 04 450 |
| milko.radicioni@croalliance.com |
Study information
| Primary study design | Interventional |
|---|---|
| Allocation | N/A: single arm study |
| Masking | Open (masking not used) |
| Control | Uncontrolled |
| Assignment | Single |
| Purpose | Basic science, Supportive care, Bioavailability evaluation of a new iron supplement formulation |
| Scientific title | Bioavailability study of a new iron supplement formulation administered as multiple doses to women single centre, multiple-dose, single-way, open-label, bioavailability study |
| Study objectives | The primary objective of the study is to investigate the bioavailability of the iron in serum after single and multiple oral administrations of Monurelle® Ferro Naturale formulation in healthy or with mild iron deficiency women. The secondary objectives of the study are: • Subjective evaluation of the product intake and participant’s satisfaction • To evaluate safety and tolerability of the investigational product. |
| Ethics approval(s) |
Approved 28/01/2026, Comitato etico cantonale (c/o Ufficio di sanità Via Orico 5, Bellinzona, 6501, Switzerland; +41 91 814 30 57; dss-ce@ti.ch), ref: 2025-02618; Ref. CE 5043 |
| Health condition(s) or problem(s) studied | The study population will include 14 healthy or with mild iron deficiency women |
| Intervention | The investigational product (i.e., one capsule of Monurelle® Ferro Naturale) will be administered once a day for 3 consecutive days. The investigational product will be orally administered in the morning, at 08:00±1 h, under fasting conditions, from Day 1 to Day 3. It will be swallowed (without chewing) by study participants with 150 mL of still mineral water at room temperature. |
| Intervention type | Supplement |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) |
|
| Completion date | 01/03/2026 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 60 Years |
| Sex | Female |
| Target sample size at registration | 14 |
| Total final enrolment | 12 |
| Key inclusion criteria | 1. Informed consent: Written informed consent signed before study inclusion. 2. Sex and age: Women aged 18–60 years (inclusive). 3. BMI: Between 18.5 and 30 kg/m² (inclusive). 4. Vital signs: Systolic blood pressure 100–139 mmHg, diastolic blood pressure 50–89 mmHg, heart rate 50–99 bpm, measured after 5 minutes of seated rest. 5. Understanding and compliance: Ability to understand the nature, purpose, risks, and requirements of the study and to comply with all study procedures. 6. Serum iron: Between 4.0 and 12.0 μmol/L at screening. 7. Menstrual cycle: Women of childbearing potential must be in days 5–20 of their menstrual cycle during the interventional phase and must not have metrorrhagia. 8. Contraception and fertility: 8.1. Women of childbearing potential must use a reliable contraceptive method for at least 2 months prior to screening (hormonal methods, non-hormonal IUD, or barrier methods with spermicide), or have a sterile partner or a partner using a condom with spermicide. True abstinence is acceptable if consistent with the woman’s usual lifestyle. 8.2. Natural methods, lactational amenorrhea, and withdrawal are not acceptable. 8.3. Women who are not of childbearing potential or who have been postmenopausal for at least 1 year are eligible. 8.4. A negative pregnancy test is required at screening and on Day -1 for all participants. |
| Key exclusion criteria | 1. ECG: Clinically significant abnormalities on 12-lead ECG (supine position). 2. Physical examination: Clinically significant abnormal findings that, in the Investigator’s opinion, may interfere with the study objectives. 3. Laboratory tests: Clinically significant abnormal laboratory values indicating illness, particularly abnormal ferritin and/or CRP levels suggesting ongoing inflammation, that may affect study outcomes. 4. Allergy: Known or suspected hypersensitivity to study product ingredients; history of anaphylaxis to drugs or supplements, or significant allergic reactions that may impact the study. 5. Medical history: Significant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, dermatological, hematological, endocrine, or neurological diseases that may interfere with the study. 6. Medications: Use of medications (including OTC drugs, herbal products, and nutritional supplements, especially iron supplements) within 2 weeks before study start that may affect study outcomes. Hormonal contraceptives are permitted. 7. Other clinical studies: Participation in another investigational product or device study within the previous 3 months (calculated from the first day of the month following the last visit of the previous study to the first day of the current study). 8. Blood donation: Blood donation within 3 months prior to the study. 9. Substance use: History (within the past 12 months) of drug abuse, alcohol consumption >1 drink/day, caffeine intake >5 cups of coffee/tea per day, or tobacco use ≥10 cigarettes/e-cigarettes per day. 10. Drug screening: Positive urine drug test at screening or Day -1. 11. Alcohol test: Positive alcohol test at screening or Day -1. 12. Diet: Abnormal diet (<1600 or >3500 kcal/day), significant dietary changes within 4 weeks prior to the study, or vegetarian diet. 13. Pregnancy/lactation: Positive or missing pregnancy test at screening or Day -1, or women who are pregnant or breastfeeding. |
| Date of first enrolment | 17/02/2026 |
| Date of final enrolment | 27/02/2026 |
Locations
Countries of recruitment
- Switzerland
Study participating centres
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | 22/04/2026 | 22/04/2026 | No | No | |
| Plain English results | 24/06/2026 | 24/06/2026 | No | Yes |
Additional files
- ISRCTN78497162_BasicResults_22April2026.pdf
- Basic results
- ISRCTN78497162_PlainEnglishResults_24Jun2026.pdf
- Plain English results
Editorial Notes
24/06/2026: Plain English results uploaded.
22/04/2026: Basic results uploaded.
17/04/2026: The plain English summary was updated.
16/04/2026: The total final enrolment was added.
27/02/2026: Study’s existence confirmed by the Ethics Committee of the Canton of Ticino (Comitato etico cantonale del Cantone Ticino - CE-TI), Switzerland.
