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UMIN-CTR Clinical Trial |
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Name | 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 |
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 |
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Condition | ||
Condition | cancers in gastrointestrinal tract
esophageal cancer, gastric cancer, colon cancer |
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Classification by specialty |
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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 |
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Interventions/Control_1 | vitamin D3 supplement | |
Interventions/Control_2 | placebo | |
Interventions/Control_3 | ||
Interventions/Control_4 | ||
Interventions/Control_5 | ||
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Interventions/Control_7 | ||
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Interventions/Control_9 | ||
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 | 1. First operation for cancer of gastrointestinal tract at International University of Health and Welfare hospital
2. Obtained informed consent |
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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 |
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Target sample size | 1 |
Research contact person | |||||||
Name of lead principal investigator |
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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 | |||||||
Public contact | |||||||
Name of contact person |
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Organization | Jikei University School of Medicine | ||||||
Division name | Division of Molecular Epidemiology | ||||||
Zip code | |||||||
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TEL | |||||||
Homepage URL | |||||||
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 | |
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 |
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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 |
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Results Delayed | |||||||
Results Delay Reason | |||||||
Date of the first journal publication of results |
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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. |
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Plan to share IPD | |||||||
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Main results already published | ||||||
Date of protocol fixation |
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Date of IRB |
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Last follow-up date |
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Date trial data considered complete |
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Date analysis concluded |
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Other | |
Other related information |
Management information | |||||||
Registered date |
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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=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 |