Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2025-12-24 @ 11:53 PM
NCT ID:
NCT02517151
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.
Study:
NCT02517151
Study Brief:
Protocol Section:
NCT02517151