Comparative study between Iron supplements: a new, patented, sublingual formulation of Iron Citrate versus SiderAL Forte® capsule, to compare the rate and extent of iron absorption after single dose administration in healthy male volunteers

Recruitment & Eligibility

Status: Completed

Sex: Male

Target Recruitment: 7

Inclusion Criteria

1. Informed consent: signed written informed consent before inclusion in the study
2. Sex and Age: males, 18-55 years old inclusive
3. Body Mass Index (BMI): 18.5-30 kg/m2 inclusive
4. Vital signs: systolic blood pressure (SBP) 100-139 mmHg, diastolic blood pressure (DBP) 50-89 mmHg, heart rate (HR) 50-90 bpm, measured after 5 min at rest in the sitting position
5. Full comprehension: ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to co-operate with the investigator and to comply with the requirements of the entire study

Exclusion Criteria

Electrocardiogram (ECG) 12-leads (supine position): clinically significant abnormalities
2. Physical findings: clinically significant abnormal physical findings which could interfere with the objectives of the study
3. Laboratory analyses: clinically significant abnormal laboratory values indicative of physical illness
4. Allergy: ascertained or presumptive hypersensitivity to the investigated nutritional product (iron) and/or formulations' ingredients (e.g. vitamin C); history of anaphylaxis to drugs, nutritional supplements or allergic reactions in general, which the investigator considered could affect the outcome of the study
5. Diseases: significant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, haematological, endocrine or neurological diseases that could interfere with the aim of the study
6. Medications: medications, including over the counter (OTC) medications, herbal remedies and nutritional supplements for 2 weeks before the start of the study

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate (Cmax) and extent (AUC0-t) of iron absorption after single dose administration of test and reference products.<br><br>Eight blood samples were drawn from each study subject 24h, 12h and 0h before and 1h, 2h, 3h, 5h and 8h after the administration of 30 mg of Fe2+ as test and reference products. Samples were analyzed in order to assess serum levels of iron at each time-point and descriptive statistics of these parameters (Both mean+SD and individual responses) were used as outcome measures.

Secondary Outcome Measures