Condition category
Nutritional, Metabolic, Endocrine
Date applied
22/01/2016
Date assigned
05/02/2016
Last edited
05/02/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Iron deficiency anaemia is a condition where a lack of iron leads to a fewer than normal number of red blood cells. This can lead to less than normal amounts of oxygen being supplied to the organs and tissues in the body. Common symptoms include feeling tired, feeling breathless, heart palpitations and looking very pale. Treatment involves taking iron supplements to increase the amount of iron in the body. Taking iron supplements, however can cause a number of side effects including abdominal pain, constipation and diarrhoea. Sublingual administration, that is placing medication under the tongue to be absorbed, should ensure that the iron is rapidly taken up by the body while avoiding the side effects typically associated with taking iron tablets. The aim of this study was to compare the bioavailability (i.e. the amount of product that reaches the circulation) of the iron, when taken orally (using the commercial product Sideral Forte®) compared to when absorbed under the tongue.

Who can participate?
Healthy adult (18-55) volunteers

What does the study involve?
Participants are randomly allocated to one of two groups. Those in group 1 take a single dose of the oral iron supplement. Those in group 2 take a single dose of the sublingual supplement. One week later all participants are given the other type of supplement to take. Blood samples are taken before and after each iron supplement is taken. These blood samples are then analysed to measure the amount of iron they contain.

What are the possible benefits and risks of participating?
No risks and no substantial benefits are associated to a single dose of iron supplements.

Where is the study run from?
CROSS Research S.A (Switzerland)

When is the study starting and how long is it expected to run for?
June 2015 to January 2016

Who is funding the study?
Biofer S.p.A. (Italy)

Who is the main contact?
1. Dr Alessandro Lapini Sacchetti (public)
2. Dr Stefania Morandi (scientific)

Trial website

Contact information

Type

Public

Primary contact

Dr Alessandro Lapini Sacchetti

ORCID ID

Contact details

Biofer S.p.A
via Canina 2
Medolla (MO)
41036
Italy

Type

Scientific

Additional contact

Dr Stefania Morandi

ORCID ID

Contact details

Biofer S.p.A
via Canina 2
Medolla (MO)
41036
Italy

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

CRO-PK-15-298 - Sponsor Code B137

Study information

Scientific title

Pilot comparative bioavailability study of sublingual administration of Iron Citrate versus SiderAL Forte® in healthy male volunteers

Acronym

Study hypothesis

Sublingual administration is more direct than oral administration because the product enters the venous circulation, avoiding the passage through the gastrointestinal tract, with the double advantage of minimising the inter-subject variability associated with the digestion process and eliminating the adverse effects associated with the passage through the gastrointestinal tract. The present exploratory study was aimed to investigate the pharmacokinetic (PK) profile of the test (T) nutraceutical product sublingual iron citrate, sachets containing 30 mg of Fe2+, vs. the reference (R) nutraceutical commercial product, capsules containing 30 mg of Fe2+.

Ethics approval

Comitato Etico Cantonale, Canton Ticino, Switzerland, 24/09/2015, ref: CE2943

Study design

Interventional, single centre, single dose, randomised, open-label, two-period, cross-over pilot study

Primary study design

Interventional

Secondary study design

Randomised cross over trial

Trial setting

Other

Trial type

Quality of life

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Iron deficiency

Intervention

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.

Intervention type

Supplement

Phase

Drug names

Primary outcome measures

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 measures

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.

Overall trial start date

24/06/2015

Overall trial end date

20/01/2016

Reason abandoned

Eligibility

Participant 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

Participant type

Healthy volunteer

Age group

Adult

Gender

Male

Target number of participants

7

Participant 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

Recruitment start date

30/09/2015

Recruitment end date

30/09/2015

Locations

Countries of recruitment

Switzerland

Trial participating centre

CROSS Research S.A
Phase I Unit Via F.A. Giorgioli 14
Arzo
CH-6864
Switzerland

Sponsor information

Organisation

Biofer S.p.A.

Sponsor details

via Canina 2
Medolla (MO)
41036
Italy

Sponsor type

Industry

Website

www.bioferspa.com

Funders

Funder type

Industry

Funder name

Biofer S.p.A. (Italy)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Biofer intends to disseminate the outcomes of this trial to doctors in medical congresses and meetings regarding anemia and other iron deficiency related conditions, starting from April 2016.

Intention to publish date

30/04/2016

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes