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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-29

Study Completion Date

2024-08-08

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Iron Deficiencies

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Monocentric, prospective, randomized study

Primary Study Purpose

OTHER

Blinding Strategy

NONE

No masking procedure will be applied

Study Groups

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ODF Iron Supplement

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

Group Type EXPERIMENTAL

ODF Iron Supplement

Intervention Type DIETARY_SUPPLEMENT

ODF iron supplement will be admistered daily for 8 weeks.

Iron Supplement in Capsule

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

Group Type ACTIVE_COMPARATOR

Iron Supplement in Capsules

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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ODF Iron Supplement

ODF iron supplement will be admistered daily for 8 weeks.

Intervention Type DIETARY_SUPPLEMENT

Iron Supplement in Capsules

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

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Sucrosomial iron

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No