UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061948 |
|---|---|
| Receipt number | R000070886 |
| Scientific Title | 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 |
| Date of disclosure of the study information | 2026/06/18 |
| Last modified on | 2026/06/17 19:34:54 |
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Basic information
Public title
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
Acronym
ALOHA Study
Scientific Title
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
Scientific Title:Acronym
ALOHA Study
Region
| Japan |
Condition
Condition
Ulcerative colitis complicated by iron deficiency anemia
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in hemoglobin level from baseline to week 12
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
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.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
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 sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Shogo |
| Middle name | |
| Last name | Kitahata |
Organization
Ehime Prefectural Central Hospital
Division name
Department of Gastroenterology
Zip code
790-0024
Address
83 Kasugamachi, Matsuyama, Ehime 790-0024, Japan
TEL
089-947-1111
shogo_kitahata@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Shogo |
| Middle name | |
| Last name | Kitahata |
Organization
Ehime Prefectural Central Hospital
Division name
Department of Gastroenterology
Zip code
790-0024
Address
83 Kasugamachi, Matsuyama, Ehime 790-0024, Japan
TEL
089-947-1111
Homepage URL
shogo_kitahata@yahoo.co.jp
Sponsor or person
Institute
Ehime Prefectural Central Hospital
Institute
Department
Personal name
Funding Source
Organization
No external funding
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ehime Prefectural Central Hospital
Address
83 Kasugamachi, Matsuyama, Ehime 790-0024, Japan
Tel
089-947-1111
shogo_kitahata@yahoo.co.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
愛媛県
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 06 | Month | 18 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
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 |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 06 | Month | 17 | Day |
Last modified on
| 2026 | Year | 06 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070886
