UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A randomized, double blind, comparative study of vitamin D3 versus placebo in patients with epithelial ovarian cancer to prevent relapse after operation and chemotherapy
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Mitsuyoshi Urashima
Organization	Jikei University School of Medicine
Division name	division of molecular epidemiology
Address	3-25-8 Minato-ku, Tokyo
TEL
Email

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

Sponsor
Institute	Jikei University School of Medicine
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2009 Year 10 Month 17 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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-bin/icdr_e/ctr_view.cgi?recptno=R000003214