INVESTIGATION OF EFFICACY AND SAFETY OF DIFFERENT IRON SUPPLEMENTATIONS IN ADULT PATIENTS WHO HAVE NON-ANEMIC IRON DEFICIENCY AND SUFFERING FROM FATIGUE

Diğer Resmi Kurumlarca Desteklenen Proje, 2024 - 2025

7. STUDY DESIGN

This is a prospective, multicenter, non-interventional registry study to investigate of efficacy and safety

of different iron supplementation preparations in adult subjects who has non-anemic iron deficiency and

suffering from fatigue in routine clinical practice.

All adult subjects who were prescribed iron supplementation preparations before enrolment to the study

and meeting the inclusion/exclusion criteria will be enrolled in the study.

As this is a non-interventional registry study, the subject’s treatments are determined solely by the

investigator, which precedes the decision to allow the subjects to participate in the study. As per local

regulations in Turkey, for non-interventional registry studies, treatments should have been previously

initiated before consenting. The trial protocol does not define the assignment of the subject to a particular

therapeutic strategy or treatment itself but the patients will be expected to use their prescribed oral iron

treatment for at least 3 months. At all times during the study, subject should be treated and monitored

in accordance with local standard of care. Any other concomitant medication should be managed by the

investigator according to the established clinical practice.

No visits or measurements will be made mandatory by the study protocol, however, the patients will be

encouraged to attend to study visits by their treating doctors. For purposes of this study, data will be

collected at baseline visit (V1), one month after baseline visit as a telephone visit (V2), at the end of the

treatment period, after three months of treatment (V3) and at the end of the follow-up period (V4) if

patients attend the study visits. However, investigators should try to make the patients participate in the

follow-up visits as the study evaluation will primarily rely on patient questionnaires (patient-reported

outcomes).

Since the study is intended to reflect usual clinical practice, investigators will not be required to perform

any mandatory subject assessments or laboratory tests. However, the data available in the patient files

will be recorded in the database on a prospective basis.

This study protocol will be submitted to the Ethics Committee of the coordinating investigator. The

study could be initiated only after obtaining the approval of Ethics Committee. Participating subjects

will be required to provide their written informed consent and will have the right to withdraw from the

study at any time. This study will be conducted with the support of a clinical research organisation

(CRO).