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)

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) - DPVD (Diabetes Prevention with Vitamin D) trial (Phase IV, multicenter, randomized, double blind, placebo controlled, and parallel group comparison)

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000010758

Enrollment

1250

Registered

2013-05-20

Start date

2013-06-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Impaired Glucose Tolerance (IGT)

Interventions

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 in

Eligibility

Sex/Gender

All

Inclusion criteria

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%

Exclusion criteria

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).

Design outcomes

Primary

Measure	Time frame
The progression from IGT to type 2 diabetes between the two groups after 3-year treatment.	—

Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Countries

Japan

Contacts

Public ContactTetsuya Kawahara

Kokura Medical Association Health Testing and Services Center Internal Medicine

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026