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Completed

NCT Number: NCT03055559

Trial Protocol GlobiFer - Oral Iron Repletion

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

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Key information

Conditions

Iron Deficiency Iron Deficiencies Iron Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–60 year

Sex eligibility

Female

Study type

Observational

Primary location

Prof. MUDr. Ján Danko, PhD.

Martin, 036 01, Slovakia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.
  • 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)

Treatment and study plan

Globifer Forte

Dietary Supplement

Primary outcomes

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

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Gedeon Richter Slovakia, s.r.o.

Other

Registry information

Official study title

Oral Iron Repletion With Globifer Forte® After 12 Weeks of Treatment

Acronym: TPG

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Feb 16, 2017
Registry last updated
Mar 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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