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

• Register: ISRCTN
• Last refreshed on: 17 October 2016
• Main ID: ISRCTN89662169
• Date of registration: 05/02/2016
• Prospective Registration: No
• Primary sponsor: Biofer S.p.A.
• Public title: 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
• Scientific title: Pilot comparative bioavailability study of sublingual administration of Iron Citrate versus SiderAL Forte® in healthy male volunteers
• Date of first enrolment: 30/09/2015
• Target sample size: 7
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN89662169
• Study type: Interventional
• Study design: Interventional, single centre, single dose, randomised, open-label, two-period, cross-over pilot study (Quality of life)

Countries of recruitment

Switzerland

Contacts

• Name: Stefania Morandi

• Name: Alessandro Lapini Sacchetti

Key inclusion & exclusion criteria

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

Age minimum:
Age maximum:
Gender: Male

Health Condition(s) or Problem(s) studied

Iron deficiency
Nutritional, Metabolic, Endocrine
Iron deficiency

Intervention(s)

A single oral dose of 30 mg of iron, i.e. one sachet of test product (T) and one capsule of reference product (R), was administered to healthy male volunteers under fasting conditions in two consecutive study periods with a wash-out interval of at least 7 days between the two administrations.

Primary Outcome(s)

Rate (Cmax) and extent (AUC0-t) of iron absorption after single dose administration of test and reference products.

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(s)

1. Ferritin and transferrin levels after single dose administration of T and R; safety and tolerability data. 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 ferritin and transferrin at each time-point and descriptive statistics of these parameters (Both mean+SD and individual responses) were used as outcome measures.
2. Safety and general tolerability of the drug, based on the following assessments:
2.1. AEs throughout the study, from informed consent up to the final visit/ETV
2.2. Vital signs were measured, at screening, on day 1 of each study period at pre-dose and 4 h post-dose, and at final visit
2.3. Physical examination was performed at screening and at final visit. Body weight (BW) was recorded at screening and at final visit/ETV.
3. Organoleptic and ease of use characteristics of test formulation assessment were evaluated by the subjects through a specific questionnaire prepared for the study. Laboratory analysis were performed at screening and at final visit.

Secondary ID(s)

CRO-PK-15-298 - Sponsor Code B137

Source(s) of Monetary Support

Biofer S.p.A. (Italy)