The effect of active vitamin D on reducing the development of type 2 diabetes from prediabetes (Phase IV, multicenter, randomized, double-blind, placebo controlled, and parallel group comparison)

The effect of active vitamin D on reducing the development of type 2 diabetes from prediabetes (Phase IV, multicenter, randomized, double-blind, placebo controlled, and parallel group comparison) - DPVD plus (Diabetes Prevention with active Vitamin D-for Patients with Low insUlin Secretion) trial (Phase IV, multicenter, randomized, double-blind, placebo controlled, and parallel group comparison)

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000048432

Enrollment

904

Registered

2022-07-22

Start date

2022-07-01

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

prediabetes (impaired fasting glucose and/or impaired glucose tolerance)

Interventions

Participants take 0.75 mcg of eldecalcitol capsule once daily for at least 3 years. However, the study will be ended when a patient is diagnosed with type 2 diabetes. First interim analysis will be pe

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. fasting plasma glucose level of <=125mg/dL and 2-hour plasma glucose level of 140 to 199mg/dl in a 75g oral glucose tolerance test (impaired glucose tolerance, IGT). OR fasting plasma glucose level of 100 to 125mg/dL and 2-hour plasma glucose level of <=199mg/dl in a 75g oral glucose tolerance test (impaired fasting glucose, IFG). 2. HbA1c < 6.5% 3. fasting IRI <=5.6mcU/mL and HOMA-beta <=44.0%.

Exclusion criteria

Exclusion criteria: Participants are ineligible if they meet any of the following criteria: have a history of diabetes; participate in other clinical trials; have a history of taking anti-diabetes drugs, other active vitamin D, and/or bisphosphonates within the past three months; are pregnant; have coronary, peripheral, or cerebrovascular disease; or have some types of severe diseases (e.g., mental disorder, collagen disease, renal insufficiency, hepatic insufficiency, or terminal disease).

Design outcomes

Primary

Measure	Time frame
The development of type 2 diabetes from prediabetes between the two groups after 3-year treatment.	—

Secondary

Measure	Time frame
1. The improvement ratio from prediabetes to normoglycemia. 2. The incidence of type 2 diabetes after adjusting for treatment group (eldecalcitol or placebo) and confounding factors at baseline: age, sex (male/female), presence or absence of hypertension (systolic 140 or more mmHg and/or diastolic 90 or more mmHg), body mass index, family history of diabetes (yes / no), HbA1c, fasting plasma glucose, 2-hour plasma glucose, 25-hydroxy vitamin D, and 1,25-dihydroxy vitamin D. 3. 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), and 1,25-dihydroxy vitamin D (more or less 20 pg/ml). 4. The incidence of adverse events between the two groups.	—

Measure

Time frame

1. The improvement ratio from prediabetes to normoglycemia. 2. The incidence of type 2 diabetes after adjusting for treatment group (eldecalcitol or placebo) and confounding factors at baseline: age, sex (male/female), presence or absence of hypertension (systolic 140 or more mmHg and/or diastolic 90 or more mmHg), body mass index, family history of diabetes (yes / no), HbA1c, fasting plasma glucose, 2-hour plasma glucose, 25-hydroxy vitamin D, and 1,25-dihydroxy vitamin D. 3. 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), and 1,25-dihydroxy vitamin D (more or less 20 pg/ml). 4. The incidence of adverse events between the two groups.

—

Countries

Japan

Contacts

Public ContactTetsuya Kawahara

Shin Komonji Hospital Endocrinology and Diabetes

dpvdtrial@mbox.med.uoeh-u.ac.jp093-391-1001

Outcome results

None listed

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