UMIN-CTR Clinical Trial

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 the two groups after 3-year treatment.
Key secondary outcomes	1. The improvement ratio from IGT to normoglycemia. 2. The incidence of type 2 diabetes in each subgroup at baseline variables: age (more or less 65 years), sex (male/female), obesity (BMI more or less 25 kg/m2), presence or absence of hypertension (systolic more 140 mmHg and/or diastolic more 90 mmHg), family history of diabetes (yes / no), fasting plasma glucose (more or less 110 mg/dl), 2-hour plasma glucose (more or less 170 mg/dl), 25-hydroxy vitamin D (more or less 20 ng/ml), HOMA-R (-1.6 / 1.61-2.49 / 2.5-), and Insulinogenic Index (more or less 0.4). 3. The incidence of type 2 diabetes after adjusting for treatment group (eldecalcitol or placebo) and each confounding factor variable at baseline: age, sex (male/female), presence or absence of hypertension (systolic more 140 mmHg and/or diastolic more 90 mmHg), body mass index, family history of diabetes (yes / no), HbA1c, fasting plasma glucose, 2-hour plasma glucose, 25-hydroxy vitamin D, HOMA-R, or insulinogenic index. 4. The incidence of adverse events between the two groups.

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 1250 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 1250 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	1250

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	Completed
Date of protocol fixation	2012 Year 11 Month 30 Day
Date of IRB	2013 Year 05 Month 01 Day
Anticipated trial start date	2013 Year 06 Month 01 Day
Last follow-up date	2019 Year 08 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	2013 Year 05 Month 19 Day
Last modified on	2021 Year 09 Month 15 Day

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