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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000046664 |
Receipt No. | R000053232 |
Scientific Title | Randomized interventional study of add-on effects of the nutritional therapy on standard treatments for patients with ulcerative colitis |
Date of disclosure of the study information | 2022/01/17 |
Last modified on | 2022/01/17 |
Basic information | ||
Public title | Randomized interventional study of add-on effects of the nutritional therapy on standard treatments for patients with ulcerative colitis | |
Acronym | Nutritional Therapy Intervention Study for Patients with Ulcerative Colitis | |
Scientific Title | Randomized interventional study of add-on effects of the nutritional therapy on standard treatments for patients with ulcerative colitis | |
Scientific Title:Acronym | Nutritional Therapy Intervention Study for Patients with Ulcerative Colitis | |
Region |
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Condition | ||
Condition | Ulcerative Colitis | |
Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | This study investigated whether nutritional guidance to promote zinc intake and a Japanese diet (high in n-3 fatty acids) could induce clinical remission in patients with mild active ulcerative colitis (UC). |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Confirmatory |
Trial characteristics_2 | Explanatory |
Developmental phase | Not applicable |
Assessment | |
Primary outcomes | The primary endpoint was clinical remission at 24 weeks. |
Key secondary outcomes | Secondary endpoints were the Ulcerative Colitis Endoscopic Index of Severity (UCEIS) scores, the clinical activity index (CAI) evaluated based on symptoms, and biomarkers, including the zinc levels, at 12 and 24 weeks. |
Base | |
Study type | Interventional |
Study design | |
Basic design | Parallel |
Randomization | Randomized |
Randomization unit | Individual |
Blinding | Single blind -investigator(s) and assessor(s) are blinded |
Control | No treatment |
Stratification | NO |
Dynamic allocation | NO |
Institution consideration | Institution is not considered as adjustment factor. |
Blocking | NO |
Concealment |
Intervention | ||
No. of arms | 2 | |
Purpose of intervention | Treatment | |
Type of intervention |
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Interventions/Control_1 | nutritional guidance (intervention group) | |
Interventions/Control_2 | control group | |
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Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | Patients had mild active UC (patients with a UCEIS score of 2-4 points, CAI score of 5-6 points, and a distribution of the UCEIS and CAI scores at admission indicating that the patient was not in remission) were enrolled in the study. | |||
Key exclusion criteria | Patients undergoing colonoscopy without pretreatment; those with difficulty following nutritional guidance; those with an intestinal obstruction, fistula, history of colorectal surgery, moderate to severe active-phase UC, diverticulitis, or massive colorectal bleeding; and those with anemia or other underlying conditions except UC were excluded. | |||
Target sample size | 20 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Saitama medical university | ||||||
Division name | Department of Gastroenterology | ||||||
Zip code | 350-0451 | ||||||
Address | Morohongo38, Moroyamamachi, Iruma-gun, Saitama Japan | ||||||
TEL | +81-49-276-1667 | ||||||
ytsuzuki38@gmail.com |
Public contact | |||||||
Name of contact person |
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Organization | Saitama Medical University | ||||||
Division name | Department of Gastroenterology | ||||||
Zip code | 350-0451 | ||||||
Address | Morohongo38, Moroyamamachi, Iruma-gun, Saitama Japan | ||||||
TEL | +81-49-276-1667 | ||||||
Homepage URL | |||||||
kaz.hr77@gmail.com |
Sponsor | |
Institute | Saitama Medical University |
Institute | |
Department |
Funding Source | |
Organization | Saitama Medical University |
Organization | |
Division | |
Category of Funding Organization | Self funding |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | Saitama medical university IRB Committee |
Address | Morohongo38, Moroyamamachi, Iruma-gun, Saitama Japan |
Tel | +81492761667 |
hirb@saitama-med.ac.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 | |
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Other administrative information | |||||||
Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
URL related to results and publications | |
Number of participants that the trial has enrolled | 20 |
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 | Completed | ||||||
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Management information | |||||||
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Last modified on |
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Link to view the page | |
URL(English) | https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053232 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |