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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000002637
Receipt No. R000003214
Scientific Title A randomized, double blind, comparative study of vitamin D3 versus placebo in patients with epithelial ovarian cancer to prevent relapse after operation and chemotherapy
Date of disclosure of the study information 2009/11/01
Last modified on 2016/04/10

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Basic information
Public title A randomized, double blind, comparative study of vitamin D3 versus placebo in patients with epithelial ovarian cancer to prevent relapse after operation and chemotherapy
Acronym Amateras VII
Scientific Title A randomized, double blind, comparative study of vitamin D3 versus placebo in patients with epithelial ovarian cancer to prevent relapse after operation and chemotherapy
Scientific Title:Acronym Amateras VII
Region
Japan

Condition
Condition ovarian cancer
Classification by specialty
Obsterics and gynecology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 We will determine if vitamin D3 peroral administration of 2000IU/day for 1 year can prevent death and relapse of ovarian cancer after operation with or without chemotherapy, by conducting a double blind randomized controlled clinical trial.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes total death
Key secondary outcomes relapse

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification YES
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
Food
Interventions/Control_1 vitamin D3
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
20 years-old <=
Age-upper limit
80 years-old >
Gender Female
Key inclusion criteria 1. First operation with or without chemotherapy for ovarian cancer at Jikei University hospitals and no residual tumor is observed.
2. Obtained informed consent
3. Age 20 and more and less than 80 years old
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 250

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 Minato-ku, Tokyo
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Jikei University School of Medicine
Division name division of molecular epidemiology
Zip code
Address
TEL
Homepage URL
Email urashima@jikei.ac.jp

Sponsor
Institute Jikei University School of Medicine
Institute
Department

Funding Source
Organization Jikei University School of Medicine
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
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 11 Month 01 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 Terminated
Date of protocol fixation
2009 Year 10 Month 17 Day
Date of IRB
Anticipated trial start date
2009 Year 11 Month 01 Day
Last follow-up date
2014 Year 10 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 10 Month 17 Day
Last modified on
2016 Year 04 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003214

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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