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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000001977
Receipt No. R000002412
Scientific Title A randomized, double blind, comparative study of vitamin D3 versus placebo in patients with cancer in gastrointestinal tract to prevent relapse after operation
Date of disclosure of the study information 2009/06/01
Last modified on 2019/04/05

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Basic information
Public title A randomized, double blind, comparative study of vitamin D3 versus placebo in patients with cancer in gastrointestinal tract to prevent relapse after operation
Acronym Amaterasu 5
Scientific Title A randomized, double blind, comparative study of vitamin D3 versus placebo in patients with cancer in gastrointestinal tract to prevent relapse after operation
Scientific Title:Acronym Amaterasu 5
Region
Japan

Condition
Condition cancers in gastrointestrinal tract
esophageal cancer, gastric cancer, colon cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 1. Targeting on cancers in gastrointestinal tract (esophageal cancer, gastric cancer and colon cancer), we examine relationship between relapse free survival and serum vitamin D concentration/single nuclear polymorphisms of vitamin D receptor
2. By peroral administration of either vitamin D3 (2,000IU) or placebo in double blind manner, vitamin D can prevent relapse and death after primary operation.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes relapse free survival
overall survival
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Double blind -all involved are blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 vitamin D3 supplement
Interventions/Control_2 placebo
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
90 years-old >
Gender Male and Female
Key inclusion criteria 1. First operation for cancer of gastrointestinal tract at International University of Health and Welfare hospital
2. Obtained informed consent
Key exclusion criteria 1. Already taking vitamin D supplement or 1,25 vitamin D
2. History of kidney stone
3. Other difficulties judged by the surgeon in charge
Target sample size 1

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mitsuyoshi Urashima
Organization Jikei University School of Medicine
Division name Division of Molecular Epidemiology
Zip code
Address 3-25-8 Nishi-shimbashi, Minato-ku, Tokyo 105-8461 Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Emi Suzuki
Organization Jikei University School of Medicine
Division name Division of Molecular Epidemiology
Zip code
Address
TEL
Homepage URL
Email emisuzu@jikei.ac.jp

Sponsor
Institute International University of Health and Welfare
Institute
Department

Funding Source
Organization Jikei University School of Medicine
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
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

Other administrative information
Date of disclosure of the study information
2009 Year 06 Month 01 Day

Related information
URL releasing protocol https://upload.umin.ac.jp/cgi-bin/icdr/ctr_up_reg_f5.cgi
Publication of results Unpublished

Result
URL related to results and publications https://upload.umin.ac.jp/cgi-bin/icdr/ctr_up_reg_f5.cgi
Number of participants that the trial has enrolled 417
Results
The 5-year RFS was 77% vs 69%; hazard ratio (HR) for relapse or death, 0.76; 95% CI, 0.50 -1.14; P = 0.18. The 5-year overall survival in the vitamin D and placebo groups was 82% vs. 81%; HR for death, 0.95; 95%CI, 0.57-1.57; P=0.83. In a subgroup of patients with serum 25(OH)D levels between 20 and 40 ng/mL at baseline, the 5-year RFS was 85% vs 71%; HR for relapse or death, 0.46; 95%CI, 0.24-0.86; P=0.02; Pinteraction=0.04. 
Results date posted
2019 Year 04 Month 05 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
2019 Year 04 Month 10 Day
Baseline Characteristics
The AMATERASU Trial was a randomized, double-blind, placebo-controlled trial at a single university hospital in Japan. Enrollment began in January 2010 and follow-up was completed in February 2018. Patients aged 30 to 90 years with cancers of the digestive tract from the esophagus to the rectum, stages I to III, were recruited. Of 439 eligible patients, 15 declined and 7 patients were excluded after operation. 
Participant flow
The patients were randomized to receive oral supplemental capsules of vitamin D (2000 IU/day, n=251) or placebo (n=166) from the first postoperative outpatient visit to until the end of the trial.
Adverse events
Fractures occurred in 3 (1.3%) of vitamin D group and 5 (3.4%) of placebo. Urinary stones were in 2 (0.9%) of vitamin D and 0 (0.0%) of placebo.
Outcome measures
The primary outcome was relapse-free survival (RFS) time to relapse or death. 
The secondary outcome was overall survival time to death from any cause. Subgroups analyzed were baseline serum 25(OH)D level 0 to <20 ng/mL, 20 to 40 ng/mL, and >40 ng/mL; because of small sample size for highest level, interactions were tested only between the low and middle baseline levels.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Main results already published
Date of protocol fixation
2009 Year 02 Month 19 Day
Date of IRB
2008 Year 12 Month 25 Day
Anticipated trial start date
2009 Year 10 Month 01 Day
Last follow-up date
2018 Year 01 Month 31 Day
Date of closure to data entry
2018 Year 02 Month 28 Day
Date trial data considered complete
2018 Year 03 Month 07 Day
Date analysis concluded
2018 Year 03 Month 21 Day

Other
Other related information

Management information
Registered date
2009 Year 05 Month 16 Day
Last modified on
2019 Year 04 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002412

Research Plan
Registered date File name
2019/04/05 Protocol + SAP (Original + final + Amandament).pdf

Research case data specifications
Registered date File name

Research case data
Registered date File name
2019/04/05 2019.3.22..data repository (1).xlsx


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