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

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 - ALOHA Study

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000061948

Enrollment

Registered

2026-06-18

Start date

2026-06-18

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ulcerative colitis complicated by iron deficiency anemia

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Change in hemoglobin level from baseline to week 12	—

Countries

Japan

Contacts

Public ContactShogo Kitahata

Ehime Prefectural Central Hospital Department of Gastroenterology

shogo_kitahata@yahoo.co.jp089-947-1111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Sep 19, 2026