Iron DeficiencyTPGNCT03055559
Trial Protocol GlobiFer - Oral Iron Repletion
An observational study of Iron Deficiency, run by Gedeon Richter Slovakia, s.r.o. at 1 site in Slovakia.
Trial summary
The haemoglobin level of the patients with iron deficiency should be increased clinical relevant after 12 weeks treatment with GlobiFer Forte. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Iron Deficiency
- What is being tested?
- Globifer Forte
- How many people
- 60 participants
- Where
- 1 siteSlovakia
- Study dates
- Jun 2016to 4 May 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: female , ≥ 18 ≤ 60 years of age
Who may be able to join
- ≥ 18 ≤ 60 years of age
- Signed written informed consent
- Hb ≥ 8 ≤ 10g/dl for
- Female
Who cannot join
- History of acquired iron overload, known haemochromatosis or first relatives with haemochromatosis, and allergic disorders (asthma, eczema, and anaphylactic reactions).
- Known hypersensitivity to oral iron preparations.
- Diseases, which an iron supplementation is not allowed or contraindicated.
- Patients on current oral or intravenous iron supplementation
- History of erythropoietin therapy in previous 30 days or scheduled for erythropoietin therapy or blood transfusion during duration of the study.
- Patients who have had iron supplementation within the last 30 days.
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- Other reasons which in the investigator's judgment argue against inclusion of the patient into the trial.
- Inability to comprehend study protocol
- Participation in another clinical trial (currently or within the last 30 days)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Oral Iron Repletion With Globifer Forte® After 12 Weeks of Treatment
The haemoglobin level of the patients with iron deficiency should be increased clinical relevant after 12 weeks treatment with GlobiFer Forte.
- Conditions
- Iron Deficiency
- Being tested
- Globifer Forte
- Keywords
- Iron, Hemoglobin, Feritin, erytrocyty. transferin
- Medical subject headings
- Iron Deficiencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Globifer ForteDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Globifer Forte | Not described Receives: Dietary Supplement: Globifer Forte |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with a clinical relevant increase of the haemoglobin level treatment with GlobiFer Forte
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2017
- Study startJun 2016
- Primary completion4 May 2017
- Study completion4 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gedeon Richter Slovakia, s.r.o.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ján Danko, PhD., Principal investigator, Comenius University's Jessenius Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03055559
- Sponsor's protocol ID
- Not identified
- Acronym
- TPG
- Status last verified
- Mar 2018
- First submitted
- 14 Feb 2017
- Last updated
- 14 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Iron Repletion With Globifer Forte® After 12 Weeks of Treatment
- ClinicalTrials.gov ID
- NCT03055559
- Acronym / sponsor ID
- TPG / Not identified
- Conditions
- Iron Deficiency
- Keywords
- Iron, Hemoglobin, Feritin, erytrocyty. transferin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Gedeon Richter Slovakia, s.r.o.University, hospital or other
- Study start
- Jun 2016
- Primary completion
- 4 May 2017 (actual)
- Study completion
- 4 May 2017 (actual)
- First posted
- 16 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The haemoglobin level of the patients with iron deficiency should be increased clinical relevant after 12 weeks treatment with GlobiFer Forte.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Globifer Forte | – | Dietary Supplement: Globifer Forte |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- female , ≥ 18 ≤ 60 years of age
Key inclusion criteria (4 listed)
- ≥ 18 ≤ 60 years of age
- Signed written informed consent
- Hb ≥ 8 ≤ 10g/dl for
- Female
Key exclusion criteria (9 listed)
- History of acquired iron overload, known haemochromatosis or first relatives with haemochromatosis, and allergic disorders (asthma, eczema, and anaphylactic reactions).
- Known hypersensitivity to oral iron preparations.
- Diseases, which an iron supplementation is not allowed or contraindicated.
- Patients on current oral or intravenous iron supplementation
- History of erythropoietin therapy in previous 30 days or scheduled for erythropoietin therapy or blood transfusion during duration of the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Globifer Forte | Dietary supplement | Globifer Forte |
Primary outcome
Proportion of patients with a clinical relevant increase of the haemoglobin level treatment with GlobiFer Forte
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2018.
- Individual participant dataSharing planned: No
Related trials for Iron Deficiency
Active, not recruiting
Absorption of Iron From Stabilized Lactoferrin: A Study in Women With Iron Deficiency
Iron Deficiency (Without Anemia)
RecruitingPhase 2
Probiotic Supplementation in Optimizing Iron and Hematological Status Among Pregnant Females
Iron Deficiency (ID), Pregnancy
Not yet recruiting
Effect of Vitamin D Supplementation Added to Iron Therapy in Children With Iron Deficiency Anemia
Iron Deficiency Anemia
Active, not recruitingPhase 2
Management of Iron Deficiency Anemia in Hemodialysis Patients
Iron Deficiency Anemia (IDA), ESRD (End Stage Renal Disease)
Not yet recruitingPhase 4
Iron Repletion in Cystic Fibrosis
Cystic Fibrosis, Iron Deficiencies
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ján Danko, PhD. principal investigator
Comenius University's Jessenius Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Iron Deficiency, run by Gedeon Richter Slovakia, s.r.o. at 1 site in Slovakia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovakia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with a clinical relevant increase of the haemoglobin level treatment with GlobiFer Forte (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2018.