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

IBSA

Status: Completed

Conditions: Iron Deficiencies

Treatments: Dietary Supplement: Iron Supplement in Capsules; Dietary Supplement: ODF Iron Supplement

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05989984

IBSAFE_CLI22

Details and patient eligibility

About

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.

Full description

The aim of the study is to evaluate the efficacy of a new iron supplement with orodispersible formulation in modulating peripheral blood biomarkers of iron levels in subjects with mild anemia after 8 weeks of supplementation, compared to baseline values and also aims to evaluate its acceptability. For the evaluation, an iron supplement in capsules will be used as a comparison supplement.

Enrollment: 23 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Written informed consent signed prior to inclusion in the study
• 18-55 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)

Exclusion criteria

• 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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23 participants in 2 patient groups

ODF Iron Supplement

Experimental group

Description:

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

Treatment:

Dietary Supplement: ODF Iron Supplement

Iron Supplement in Capsule

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Iron Supplement in Capsules