A Prospective, Open-Label, Randomized, Interventional Study to Evaluate the Efficacy and Tolerability of Sucrosomial® Iron vs Ferric Maltol in Iron Deficient Women

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Pharmanutra S.p.A.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Female

Therapeutic area

Diseases [C] - Hemic and Lymphatic Diseases [C15]

Trial duration

11 Dec 2025 → ongoing

Decision date (initial)

2025-10-06

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

PharmaNutra S.p.A.

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

To determine the efficacy of Sucrosomial® Iron versus Ferric Maltol in achieving the normalization of Hemoglobin (Hb) levels

Secondary objectives 7

1. To determine the efficacy of Sucrosomial® Iron versus Ferric Maltol in achieving the normalization of Hemoglobin (Hb) levels at each timepoint
2. To assess the tolerability of Sucrosomial® Iron versus Ferric Maltol
3. To evaluate the normalization of laboratory values (sideremia, ferritin and TSAT) patients
4. To assess improvement in clinical symptoms of fatigue
5. To evaluate the variation in Hemoglobin levels between treatments
6. To evaluate Hemoglobin level variation in a subgroup of women with chronic inflammation (according to baseline CRP values).
7. To evaluate the acceptability of Sucrosomial® iron versus Ferric Maltol in terms of taste and its impact on treatment continuation.

Conditions and MedDRA coding

iron deficient

Study design 7 periods

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. Females ≥ 18 years
2. Mild anemia (11.0 ≤ Hb < 12 g/dl) or moderate anemia (8.0 < Hb <11 g/dl)
3. Signed informed consent form before enrollment

Exclusion criteria 14

1. Concomitant use, or in the last month preceding the screening, of other martial drugs or supplements (supplement or drug containing iron).
2. Concomitant use of erythropoietin or its use within the three months prior to screening
3. Need - from the Investigator's point of view – for transfusion of concentrated erythrocytes and/or for intravenous iron infusion
4. Presence of IBD in the phase of severe activity, defined as: HBI index>16 in patients with Crohn's disease and CAI index >12 in patients with ulcerative colitis
5. Previous bariatric surgery
6. Alcohol abuse
7. Hemochromatosis and other iron overload syndromes
8. History of hereditary anemia, including thalassemia
9. History of hypersensitivity to any ingredients
10. History of psychiatric disorders that prevent the expression of informed consent or correct assumption of treatment
11. Active cancer disease except for subjects with fibroids and polyps.
12. Pregnant or nursing female patients are not eligible for this study. Pregnancy tests with a negative result must be obtained in all post-menarchal females who are not using pharmacological or barrier contraceptive methods (e.g., oral contraceptives, contraceptive patches, intrauterine devices, condoms, or diaphragms). Non-breastfeeding women are not eligible until 6 months after delivery
13. Patients participating in another experimental intervention study or receiving another experimental treatment
14. History of poor adherence to medical or patient regimes that are considered potentially unreliable and/or uncooperative, unavailable or unable to adhere to the protocol

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Proportion of patients who achieved hemoglobin normalization at the end of the 12-week treatment period (Hb ≥ 12 g/dl).

Secondary endpoints 10

1. Proportion of patients who achieved hemoglobin normalization at each timepoint
2. Proportion of patients who experience adverse events (AEs) or serious adverse events (SAEs).
3. Number of patients who withdraw from the study due to adverse events.
4. Number of patients who discontinue treatment due to side effects.
5. Proportion of patients who achieve normalization of laboratory values (sideremia, ferritin and TSAT).
6. Proportion of patients who show improvement in clinical symptoms according to the FACIT Fatigue Scale version 4.0.
7. Differences in Hemoglobin level variation from baseline between Sucrosomial® Iron and Ferric Maltol treatments.
8. Differences in Hemoglobin level variation at each timepoint between Sucrosomial® Iron and Ferric Maltol treatments.
9. Differences in Hemoglobin level variation from baseline between Sucrosomial® Iron and Ferric Maltol treatments in the subgroup of women with chronic inflammation (based on baseline CRP values). CRP values categorized as follows: Normal (CRP < 0.3 mg/dl); Normal or minor elevation (0.3 ≤ CRP < 1.0 mg/dl); Moderate elevation (1.0 ≤ CRP ≤ 10.0 mg/dl); Marked elevation (CRP > 10.0 mg/dl).
10. Proportion of patients reporting refusal to take the product or discontinue due to its taste.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Pharmanutra S.p.A.

Sponsor organisation

Pharmanutra S.p.A.

Address

Via Campodavela 1

City

Pisa

Postcode

56122

Country

Italy

Scientific contact point

Organisation

Pharmanutra S.p.A.

Contact name

Maria Sole Rossato

Public contact point

Organisation

Pharmanutra S.p.A.

Contact name

Alicia Navarro Cid

Third parties 3

Locations

1 EU/EEA country · 7 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 12 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications