UMIN-CTR Clinical Trial

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

colorectal tumor

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO

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

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)

Study type

Interventional

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

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

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

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

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

Institute

National Center for Global Health and Medicine, Clinical Research Center

Institute

Department

Personal name

Organization

Ministry of Health and Labour and Welfare

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan

Co-sponsor

Saitama Red Cross Hospital

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

さいたま赤十字病院（埼玉県）

Date of disclosure of the study information

2011

Year

01

Month

11

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2011

Year

01

Month

10

Day

Last modified on

2013

Year

07

Month

11

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005777