Efficacy Evaluation of an ODF Iron Supplement vs an Iron Supplement in Capsules in Subjects With Mild Anemia

Study Overview
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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.

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.

Official Title
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Monocentric, Prospective, Randomized Study to Evaluate the Efficacy of a New Iron Supplement With Orodispersible Formulation vs an Iron Supplement in Capsules in Subjects With Mild Anemia

Conditions
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Iron Deficiencies

Intervention / Treatment
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* Dietary Supplement: ODF Iron Supplement
* Dietary Supplement: Iron Supplement in Capsules


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Monocentric, prospective, randomized study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ODF Iron Supplement<br>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<br>* ODF iron supplement will be admistered daily for 8 weeks.<br>|
| Active Comparator: Iron Supplement in Capsule<br>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<br>* Iron supplement in capsule will be admistered daily for 8 weeks.<br>* Other names: Sucrosomial iron;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in blood concentration of hemoglobin with test product | Change from baseline in blood concentration of hemoglobin after 4 weeks of supplementation with test product | Day 0, Week 4 | 
| Change from baseline in blood concentration of hemoglobin with Iron supplement in capsule (reference product) | Change from baseline in blood concentration of hemoglobin after 8 weeks of supplementation with Iron supplement in capsule | Day 0, Week4, Week 8 | 
| Change from baseline in blood concentration of hematocrit | Evalution of the change from baseline of hematocrit after administration of test versus reference product | Day 0, Week4, Week 8 | 
| Change from baseline in blood concentration of ferritin | Evalution of the change from baseline of ferritin after administration of test versus reference product | Day 0, Week4, Week 8 | 
| Change from baseline in blood concentration of transferrin | Evalution of the change from baseline of transferrin after administration of test versus reference product | Day 0, Week4, Week 8 | 
| Change from baseline in blood concentration of transferrin receptor | Evalution of the change from baseline of transferrin receptor after administration of test versus reference product | Day 0, Week4, Week 8 | 
| Change from baseline in blood concentration of folic acid | Evalution of the change from baseline of folic acid after administration of test versus reference product | Day 0, Week4, Week 8 | 
| Change from baseline in blood concentration of serum iron | Evalution of the change from baseline of serum iron after administration of test versus reference product | Day 0, Week4, Week 8 | 
| Change from baseline in mean corpuscolar volume (MCV) | Evalution of the change from baseline of MCV after administration of test versus reference product | Day 0, Week4, Week 8 |