Active vitamin D treatment and Prevention of Sarcopenia in Adults with Prediabetes

Effect of Active Vitamin D Treatment on Sarcopenia Incidence Among Adults with Prediabetes - Randomized Controlled Trial- - DPVD ancillary trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000005394

Enrollment

1092

Registered

2011-04-07

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

Sarcopenia, Prediabetes, Diabetes Mellitus

Interventions

the eldecalcitol group the placebo group

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Men and women aged 30 years or older. 2. Individuals diagnosed with prediabetes without sarcopenia 3. Serum calcium level (corrected value) < 11.0 mg/dl.

Exclusion criteria

Exclusion criteria: 1. Individuals who have participated in other clinical trials. 2. Individuals who have been treated with active vitamin D, vitamin D supplement, and/or calcium preparation within the preceding 3-month period. 3. Individuals who have already been diagnosed with type 1, type 2 diabetes, and/or sarcopenia. 4. Individuals in whom drug treatment for prediabetes has been initiated. 5. Individuals who are pregnant or have severe diseases, such as renal insufficiency (serum creatinine of 1.5 mg/dl or higher), hepatic insufficiency, psychosis, collagen diseases, heart diseases, and cerebrovascular diseases. 6. A sub investigator may preclude participant involvement in the study based on screening and assessment of the participants condition.

Design outcomes

Primary

Measure	Time frame
The Primary endpoint is the incidence of sarcopenia after a 3-year study period ... the eldecalcitol group vs. the placebo group	—

Secondary

Measure	Time frame
The secondary endpoints are the changes in skeletal muscle volume, strength (handgrip strength), and body fat mass .... the eldecalcitol group vs. the placebo group In the secondary analyses, we examine the modification of the treatment effect in prespecified subgroups, defined by age, sex, BMI, fat mass index, lean mass index, appendicular skeletal muscle index, baseline serum 25-hydroxyvitamin D levels, baseline serum 1,25-dihydroxy vitamin D levels, and the trial group.	—

Measure

Time frame

The secondary endpoints are the changes in skeletal muscle volume, strength (handgrip strength), and body fat mass .... the eldecalcitol group vs. the placebo group In the secondary analyses, we examine the modification of the treatment effect in prespecified subgroups, defined by age, sex, BMI, fat mass index, lean mass index, appendicular skeletal muscle index, baseline serum 25-hydroxyvitamin D levels, baseline serum 1,25-dihydroxy vitamin D levels, and the trial group.

—

Countries

Japan

Contacts

Public ContactTetsuya Kawahara

Shin Komonji Hospital Endocrinology and Diabetes

k-tetsuy@med.uoeh-u.ac.jp+81-93-391-1001

Outcome results

None listed

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