Clinical Trial: A prospective randomized delayed-start trial of Alternate-day Low-dose Oral Iron Therapy for Improving Health in Patients with Ulcerative Colitis and Iron Deficiency Anemia (Japan)

Tokyo, June 19 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061948) titled 'A prospective randomized delayed-start trial of Alternate-day Low-dose Oral Iron Therapy for Improving Health in Patients with Ulcerative Colitis and Iron Deficiency Anemia' on June 18.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -no one is blinded Control - No treatment

Primary Sponsor: Institute - Ehime Prefectural Central Hospital

Condition: Condition - Ulcerative colitis complicated by iron deficiency anemia Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The purpose of this study is to prospectively evaluate the efficacy and safety of low-dose alternate-day oral iron therapy for relatively mild iron deficiency anemia in patients with ulcerative colitis. This study also aims to assess the clinical significance of early intervention by comparing an immediate-start group with a delayed-start group. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Immediate-start group: Oral sodium ferrous citrate equivalent to 50 mg elemental iron will be administered every other day for 12 weeks immediately after enrollment, followed by observation until week 52. Interventions/Control_2 - Delayed-start group: Patients will be observed for the first 12 weeks after enrollment. Thereafter, oral sodium ferrous citrate equivalent to 50 mg elemental iron will be administered every other day for 12 weeks, followed by observation until week 52.

Eligibility: Age-lower limit - 16 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Patients aged 16 years or older with ulcerative colitis Patients with iron deficiency anemia Hemoglobin levels of 11.0 to <13.0 g/dL for men and 10.0 to <12.0 g/dL for women Written informed consent obtained Key exclusion criteria - Patients indicated for intravenous iron therapy Patients suspected of anemia due to causes other than iron deficiency Pregnant or breastfeeding women History of intravenous iron therapy within 12 weeks or oral iron therapy within 4 weeks History of total or subtotal colectomy Target Size - 90

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 05 Month 26 Day Date of IRB - 2026 Year 06 Month 18 Day Anticipated trial start date - 2026 Year 06 Month 18 Day Last follow-up date - 2031 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070886

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