Efficacy Evaluation of an ODF Iron Supplement Vs an Iron Supplement in Capsules in Subjects with Mild Anemia

NCT05989984 | Completed

• 1 other identifier: IBSAFE_CLI22
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to evaluate the efficacy of a new iron supplement with orodispersible formulation vs an iron supplement in capsules in subjects with mild anemia.

Conditions

Iron Deficiencies

Outcome Measures

Primary Outcomes (1)

• Change from baseline in blood concentration of hemoglobin with ODF iron supplement (test product)

  Change from baseline in blood concentration of hemoglobin after 8 weeks of supplementation with ODF iron supplement

  Day 0, Week 8

Secondary Outcomes (9)

• Change from baseline in blood concentration of hemoglobin with test product

  Day 0, Week 4

• Change from baseline in blood concentration of hemoglobin with Iron supplement in capsule (reference product)

  Day 0, Week4, Week 8

• Change from baseline in blood concentration of hematocrit

  Day 0, Week4, Week 8

• Change from baseline in blood concentration of ferritin

  Day 0, Week4, Week 8

• Change from baseline in blood concentration of transferrin

  Day 0, Week4, Week 8

Study Arms (2)

ODF Iron Supplement

EXPERIMENTAL

ODF iron supplement contains 30 mg of elemental iron (corresponding to 120 mg of ferric pyrophosphate) and 400 μg of folic acid.

Dietary Supplement: ODF Iron Supplement

Iron Supplement in Capsule

ACTIVE COMPARATOR

Iron supplement in capsule contains 30 mg of elemental iron (corresponding to 120 mg of ferric pyrophosphate) and 70 mg of vitamin C.

Dietary Supplement: Iron Supplement in Capsules

Interventions

ODF Iron Supplement DIETARY_SUPPLEMENT

ODF iron supplement will be admistered daily for 8 weeks.

ODF Iron Supplement

Iron Supplement in Capsules DIETARY_SUPPLEMENT

Iron supplement in capsule will be admistered daily for 8 weeks.

Also known as: Sucrosomial iron

Iron Supplement in Capsule

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• years
• Ability to understand the nature and the purpose of the study, including possible risks and side effects
• Capability to collaborate with the investigator and meet the requirements of the entire study
• Subjects with mild anemia (with WHO hemoglobin values between 11-11.9 g/dl for women and between 11-12.9 g/dl for men)

You may not qualify if:

• Clinically significant abnormalities in the ECG evaluation
• Clinically significant abnormal laboratory values indicative of disease
• Known allergy or presumed hypersensitivity to the food supplement investigated (iron) and / or to the excipients of the two formulations
• History of anaphylaxis from drugs, dietary supplements or allergic reactions in general, which the investigator believed could influence the outcome of the study
• Significant history of kidney, liver, gastrointestinal, cardiovascular, respiratory, skin, haematological, endocrine or neurological diseases that may interfere with the purpose of the study
• Taking herbal remedies and dietary supplements (including iron supplements, supplements with vitamin C, supplements with folic acid, supplements with vitamin B12, multivitamins) in the 2 weeks prior to the start of the study
• Taking corticosteroids, thyroid hormones, antibiotics, antiepileptics
• Alcohol abuse
• Any clinical condition that in the investigator's judgment is deemed incompatible with study participation
• Women who are pregnant or breastfeeding

Sponsors & Collaborators

• IBSA Farmaceutici Italia Srl: lead
• Informapro Srl: collaborator

Study Sites (1)

Fondazione Policlinico Universitario Campus Bio-Medico di Roma

Roma, Italy, 00128, Italy

Location

MeSH Terms

Conditions

Iron Deficiencies

Interventions

Iron-Dextran Complex; Capsules; sucrosomial iron

Condition Hierarchy (Ancestors)

Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Dextrans; Glucans; Polysaccharides; Carbohydrates; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Silvia Angeletti

  Operative Research Unit of Clinical Laboratory

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No masking procedure will be applied
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Monocentric, prospective, randomized study

Study Record Dates

• First Submitted: August 4, 2023
• First Posted: August 14, 2023
• Study Start: July 29, 2023
• Primary Completion: August 8, 2024
• Study Completion: August 8, 2024
• Last Updated: January 8, 2025

Record last verified: 2025-01

Locations

IT (1)