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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000001869
Receipt No. R000002252
Scientific Title A randomized, double blind, comparative study of STATUS D3 (vitamin D3) versus placebo in patients with lung cancer to prevent relapse after operation
Date of disclosure of the study information 2009/04/10
Last modified on 2019/04/18

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Basic information
Public title A randomized, double blind, comparative study of STATUS D3 (vitamin D3) versus placebo in patients with lung cancer to prevent relapse after operation
Acronym Amaterasu 4
Scientific Title A randomized, double blind, comparative study of STATUS D3 (vitamin D3) versus placebo in patients with lung cancer to prevent relapse after operation
Scientific Title:Acronym Amaterasu 4
Region
Japan

Condition
Condition lung cancer
Classification by specialty
Chest surgery
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 We will determine if vitamin D3 peroral administration of 1200IU/day for 1 year can prevent relapse of lung cancer after operation, by conducting a double blind randomized controlled clinical trial and by stratification with vitamin D receptor SNPs as well as with pathological stages.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes disease free survival
Key secondary outcomes

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
Medicine
Interventions/Control_1 vitamin D3 suppliment
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
75 years-old >
Gender Male and Female
Key inclusion criteria 1. First operation for lung cancer at Jikei University hospitals
2. Obtained informed consent
3. Age 20 and more and less than 75 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 300

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
TEL 03-3433-1111
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 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 04 Month 10 Day

Related information
URL releasing protocol https://www.ncbi.nlm.nih.gov/pubmed/30018118
Publication of results Published

Result
URL related to results and publications https://www.ncbi.nlm.nih.gov/pubmed/30018118
Number of participants that the trial has enrolled 155
Results
The 5-year RFS of the vitamin D and placebo groups was 65% and 57%, respectively (HR, 1.15; 95%CI, 0.64 to 2.05; P=0.64). The 5-year OS of the vitamin D and placebo groups was 76% and 78%, respectively (HR, 1.22; 95%CI, 0.54 to 2.79; P=0.63).
Results date posted
2019 Year 04 Month 18 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The mean age was 68 years, and three-quarters of the patients were men. Early stages from IA to IIB and adenocarcinoma accounted for 90% and 81% of the study population, respectively.
Participant flow
A total of 155 patients with NSCLC were randomly assigned to receive vitamin D supplements (n=77) or placebo (n=78) in a double-blind setting. 72 patients in the vitamin D group and 72 patients in the placebo group were analyzed. 
Adverse events
There were no more cases of urinary stones, hypercalcemia, and serious adverse events in the vitamin D group than in the placebo group.
Outcome measures
The primary and secondary outcomes were RFS and OS, respectively. 
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Main results already published
Date of protocol fixation
2009 Year 03 Month 11 Day
Date of IRB
2009 Year 03 Month 20 Day
Anticipated trial start date
2009 Year 05 Month 01 Day
Last follow-up date
2018 Year 03 Month 31 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 04 Month 10 Day
Last modified on
2019 Year 04 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002252

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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