NCT03055559

Brief Summary

The haemoglobin level of the patients with iron deficiency should be increased clinical relevant after 12 weeks treatment with GlobiFer Forte.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

February 14, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 16, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 4, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 4, 2017

Completed
Last Updated

March 14, 2018

Status Verified

March 1, 2018

Enrollment Period

11 months

First QC Date

February 14, 2017

Last Update Submit

March 13, 2018

Conditions

Iron Deficiency

Keywords

Iron, Hemoglobin, Feritin, erytrocyty. transferin

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients with a clinical relevant increase of the haemoglobin level treatment with GlobiFer Forte

    12 weeks

Study Arms (1)

Globifer Forte

Dietary Supplement: Globifer Forte

Interventions

Globifer ForteDIETARY_SUPPLEMENT
Globifer Forte

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

female , ≥ 18 ≤ 60 years of age

You may qualify if:

  • ≥ 18 ≤ 60 years of age
  • Signed written informed consent
  • Hb ≥ 8 ≤ 10g/dl for
  • Female

You may not qualify if:

  • 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.
  • Inability to comprehend study protocol
  • Participation in another clinical trial (currently or within the last 30 days)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prof. MUDr. Ján Danko, PhD.

Martin, 036 01, Slovakia

Location

MeSH Terms

Conditions

Iron Deficiencies

Condition Hierarchy (Ancestors)

Iron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Ján Danko, PhD.

    Comenius University's Jessenius Faculty of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 14, 2017

First Posted

February 16, 2017

Study Start

June 1, 2016

Primary Completion

May 4, 2017

Study Completion

May 4, 2017

Last Updated

March 14, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations

SL(1)