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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000004854
Receipt No. R000005777
Scientific Title Randomized controlled trial for the prevention of colorectal tumor recurrence by vitamin D and calcium supplementation
Date of disclosure of the study information 2011/01/11
Last modified on 2013/07/11

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Basic information
Public title Randomized controlled trial for the prevention of colorectal tumor recurrence by vitamin D and calcium supplementation
Acronym Randomized controlled trial for the prevention of colorectal tumor recurrence by vitamin D and calcium supplementation
Scientific Title Randomized controlled trial for the prevention of colorectal tumor recurrence by vitamin D and calcium supplementation
Scientific Title:Acronym Randomized controlled trial for the prevention of colorectal tumor recurrence by vitamin D and calcium supplementation
Region
Japan

Condition
Condition colorectal tumor
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The primary objective is to examine whether vitamin D (1200 IU/day) and calcium (400 mg/day) supplementation decreases colorectal tumor recurrence. We also examine whether the supplementation prevents influenza and allergic and depressive symptoms and improves blood pressure and metabolism of glucose, lipids, and bone.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes Reccurrence rate of colorectal tumor (adenoma or cancer) on endoscopic examination at 24 to 28 month or earlier.
Key secondary outcomes 1) Occurrence rate of high-risk colorectal adenoma or cancer in terms of size, number, and histology
2) adverse event rate

(Outcomes other than colorectal tumor)
1) influenza: diagnosis of influenza, occurrence of influenza-like illness
2) allergy: occurrence of allergic disease and symptoms
3) blood pressure
4) glucose metabolism: fasting gluose, HbA1c, insulin, C-peptide, HOMA-IR
5) lipids: total/HDL/LDL-cholesterol, triglycerides, fatty acid composition
6) inflammation: hs-CRP, IL6, adiponectin, leptin, TNF-alpa, PAI-1, other markers of inflamation
7) bone metabolism: Intact parathyroid hormone (PTH), Osteocalcin, Type I collagen cross-linked N-telopeptides(NTX)
8) depression: CES-D

(For extended study: additional two-year observation)
1) 4-year reccurrence rate of colorectal tumor (adenoma or cancer)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Other
Interventions/Control_1 Daily use of supplements containing vitamin D (1,200 IU) and calcium (400 mg)
Interventions/Control_2 Daily use of supplements containing calcium (400 mg)
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
30 years-old <=
Age-upper limit
74 years-old >=
Gender Male and Female
Key inclusion criteria Patients who fulfill all the criteria below.
1) Age: 30 to 74 years old
2) Patients who had adenoma or early colorectal cancer, which is confirmed by either image-enhanced endoscopy or histological examination, removed endoscopically in a curative manner within past 3 years. For patients who received tumor resection in hospitals other than Saitama Red Cross hosiptal, the tumor histology needs to be verified by a relevant document.
3) Patients with clean colon confirmed by total colonoscopy that took 15 minutes or longer within 3 months
Key exclusion criteria 1) Patients with familial polyposis coli, hereditary nonpolyposis colorectal cancer, ulcerative colitis
2) Patients who have undergone surgical resection of the colorectum
3) Patients who use vitamin D (400IU or greater per day) supplement
4) Patients who take non-steroidal anti-inflammatory drugs 3 times or more per week
5) Patients who take vitamin D or calcium supplement as prescribed by a doctor
6) Patients with a history of cancer (excluding those with a history of curative resection of early colorectal cancer or cancer of site other than the colorectum), cerebrovascular events, urinary tract stone, chronic kidney disease, thyroid disease, chronic liver disease (chronic hepatitis, liver cirrhosis), psychiatric disease
7) Patients who have known or anticipated difficulties for study participation throughout study period
8) Patients who are judged by his/her doctor to be unsuitable for study participation
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tetsuya Mizoue1), Keita Sasajima2)
Organization 1) National Center for Global Health and Medicine, Clinical Research Center; 2) Saitama Red Cross Hospital
Division name 1) Department of Epidemiology and Prevention, 2) Department of Gatroenterology
Zip code
Address 1) 1-21-1 Toyama, Shinjuku-ku, Tokyo, Japan; 2) 8-3-33 Kamiochiai, Chuo-ku, Saitama, Japan
TEL 03-3202-7181
Email

Public contact
Name of contact person
1st name
Middle name
Last name Tetsuya Mizoue
Organization National Center for Global Health and Medicine, Clinical Research Center
Division name Department of Epidemiology and Prevention
Zip code
Address 1-21-1 Toyama, Shinjuku-ku, Tokyo, Japan
TEL 03-3202-7181
Homepage URL
Email mizoue@ri.ncgm.go.jp

Sponsor
Institute National Center for Global Health and Medicine, Clinical Research Center
Institute
Department

Funding Source
Organization Ministry of Health and Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Saitama Red Cross Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 さいたま赤十字病院(埼玉県)

Other administrative information
Date of disclosure of the study information
2011 Year 01 Month 11 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 Enrolling by invitation
Date of protocol fixation
2010 Year 11 Month 24 Day
Date of IRB
Anticipated trial start date
2011 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 01 Month 10 Day
Last modified on
2013 Year 07 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005777

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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