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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000010758
Receipt No. R000012436
Scientific Title The effect of activated vitamin D on reducing the progression from impaired glucose tolerance (IGT) to type 2 diabetes (Phase IV, multicenter, randomized, double blind, placebo controlled, and parallel group comparison)
Date of disclosure of the study information 2013/05/20
Last modified on 2017/07/07

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Basic information
Public title The effect of activated vitamin D on reducing the progression from impaired glucose tolerance (IGT) to type 2 diabetes (Phase IV, multicenter, randomized, double blind, placebo controlled, and parallel group comparison)
Acronym DPVD (Diabetes Prevention with Vitamin D) trial
(Phase IV, multicenter, randomized, double blind, placebo controlled, and parallel group comparison)
Scientific Title The effect of activated vitamin D on reducing the progression from impaired glucose tolerance (IGT) to type 2 diabetes (Phase IV, multicenter, randomized, double blind, placebo controlled, and parallel group comparison)
Scientific Title:Acronym DPVD (Diabetes Prevention with Vitamin D) trial
(Phase IV, multicenter, randomized, double blind, placebo controlled, and parallel group comparison)
Region
Japan

Condition
Condition Impaired Glucose Tolerance (IGT)
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this trial is to evaluate the effect of activated vitamin D to reduce the progression from IGT to type 2 diabetes, as compared with placebo.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase IV

Assessment
Primary outcomes The progression from IGT to type 2 diabetes between two groups.
Key secondary outcomes 1. The improvement ratio from IGT to normoglycemia.
2. The change in homeostasis model assessment for insulin resistance (HOMA-R).
3. The change in body weight and body mass index (BMI).
4. Influence of hypertension, hyperlipidemia, obesity, fasting plasma glucose level, 2 hours plasma glucose level, serum 25(OH)D3 level, smoking, HOMA-R, and Insulinogenic Index to incidence of type 2 diabetes.

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 considered as a block.
Blocking YES
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 Participants receive 0.75 ug of eldecalcitol cap. per day for at least 144 weeks or by the timepoint of progression type 2 diabetes. After one year of enrollment of all 1242 participants, the first interim analysis will be done.In addition, when total 142 participants are diagnosed as type 2 diabetes, that is 60% of the expected diabetes incidence, the second interim analysis will be done.
Interventions/Control_2 Participants receive placebo cap. per day for at least 144 weeks or by the timepoint of progression type 2 diabetes. After one year of enrollment of all 1242 participants, the first interim analysis will be done.In addition, when total 142 participants are diagnosed as type 2 diabetes, that is 60% of the expected diabetes incidence, the second interim analysis will be done.
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. fasting plasma/serum glucose level <126mg/dl and 2-hour plasma/serum glucose level: 140 to 199mg/dl in a 75g oral glucose tolerance test.
2. HbA1c < 6.5%
Key exclusion criteria Participants are ineligible if they meet any of the following criteria: have a history of diabetes; participate in other investigational trials; have a history of taking anti-diabetic drugs, other activated vitamin D, or bisphosphonates within past three months; are pregnant; have coronary, peripheral, or cerebrovascular disease; or have some types of a severe disease (e.g., renal insufficiency, hepatic insufficiency, terminal disease).
Target sample size 1242

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshiya Tanaka
Organization University of Occupational and Environmental Health
Division name The First Department of Internal medicine
Zip code
Address 1-1 Iseigaoka, Yahatanishiku, Kitakyusyushi, Fukuoka, JAPAN
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Tetsuya Kawahara
Organization Kokura Medical Association Health Testing and Services Center
Division name Internal Medicine
Zip code
Address 1-19-17 Nakashima, Kokurakitaku, Kitakyushu, Fukuoka, JAPAN
TEL
Homepage URL
Email

Sponsor
Institute Kokura Medical Association Health Testing and Services Center
Institute
Department

Funding Source
Organization University of Occupational and Environmental Health
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

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
2013 Year 05 Month 20 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 Open public recruiting
Date of protocol fixation
2012 Year 11 Month 30 Day
Date of IRB
Anticipated trial start date
2013 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 05 Month 19 Day
Last modified on
2017 Year 07 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012436

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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