Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2025-12-25 @ 9:48 PM
Study NCT ID:
NCT02517151
Status:
UNKNOWN
Last Update Posted:
2015-09-10
First Post:
2015-08-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Iron Supplementation in Inflammatory Bowel Disease (IBD) Patients With Chronic Fatigue
Sponsor:
Istituto Clinico Humanitas
Organization:
Study Overview
Official Title:
Effects of Iron Therapy in Patients With Chronic Fatigue and IBD
Status:
UNKNOWN
Status Verified Date:
2015-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MICI_2011-01
Brief Summary:
A phase 2, randomized, placebo controlled trial evaluating the effects of n intravenous iron supplementation on chronic fatigue in IBD patients with controlled disease.
Detailed Description:
The study will evaluate a 6 months therapy with intravenous ferric carboxymaltose.
Patients will undergo a 2-5 days screening period and then will be treated every 4 weeks with iron supplementation/placebo.
At every visit, hematology and blood iron levels will be evaluated. Treatment will be temporarily stopped in case of either Hemoglobin levels above 16 g/dl or ferritin above 800 ng/ml (level decreased to 500 ng/ml in case of Transferrin-Iron Saturation Percentage above 50%).
Study team will be composed of blinded and unblinded personnel and dedicated infusion devices will be used to ensure the double blinding.
Patients will undergo a 2-5 days screening period and then will be treated every 4 weeks with iron supplementation/placebo.
At every visit, hematology and blood iron levels will be evaluated. Treatment will be temporarily stopped in case of either Hemoglobin levels above 16 g/dl or ferritin above 800 ng/ml (level decreased to 500 ng/ml in case of Transferrin-Iron Saturation Percentage above 50%).
Study team will be composed of blinded and unblinded personnel and dedicated infusion devices will be used to ensure the double blinding.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: