UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005394 |
|---|---|
| Receipt number | R000006404 |
| Scientific Title | Effect of Active Vitamin D Treatment on Sarcopenia Incidence Among Adults with Prediabetes - Randomized Controlled Trial- |
| Date of disclosure of the study information | 2011/04/07 |
| Last modified on | 2023/01/04 11:23:54 |
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Basic information
Public title
Active vitamin D treatment and Prevention of Sarcopenia in Adults with Prediabetes
Acronym
Prevention of Sarcopenia Trial
Scientific Title
Effect of Active Vitamin D Treatment on Sarcopenia Incidence Among Adults with Prediabetes - Randomized Controlled Trial-
Scientific Title:Acronym
DPVD ancillary trial
Region
| Japan |
Condition
Condition
Sarcopenia, Prediabetes, Diabetes Mellitus
Classification by specialty
| Medicine in general | Endocrinology and Metabolism | Geriatrics |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Observational studies show inverse associations between serum vitamin D levels and sarcopenia incidence; however, it remains unclear whether treatment with vitamin D prevents its development.
We test whether treatment with active vitamin D would result in a lower risk of sarcopenia in an ancillary study of diabetes prevention with active vitamin D (DPVD).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase IV
Assessment
Primary outcomes
The Primary endpoint is the incidence of sarcopenia after a 3-year study period ... the eldecalcitol group vs. the placebo group
Key secondary outcomes
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.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
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
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
the eldecalcitol group
Interventions/Control_2
the placebo group
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. 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.
Key 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.
Target sample size
1092
Research contact person
Name of lead principal investigator
| 1st name | Tetsuya |
| Middle name | |
| Last name | Kawahara |
Organization
Shin Komonji Hospital
Division name
Endocrinology and Metabolism
Zip code
800-0057
Address
2-5 Dairishinmachi, Moji, Kitakyushu, JAPAN
TEL
+81-93-391-1001
k-tetsuy@med.uoeh-u.ac.jp
Public contact
Name of contact person
| 1st name | Tetsuya |
| Middle name | |
| Last name | Kawahara |
Organization
Shin Komonji Hospital
Division name
Endocrinology and Diabetes
Zip code
800-0057
Address
2-5 Dairishinmachi, Moji, Kitakyushu
TEL
+81-93-391-1001
Homepage URL
http://www.shinkomonji-hp.jp/
k-tetsuy@med.uoeh-u.ac.jp
Sponsor or person
Institute
University of Occupational and Environmental Health
Kokura Medical Association, Health Testing Center
Fujisawa City Hospital
Shin Komonji Hospital
Institute
Department
Personal name
Funding Source
Organization
Kitakyushu Medical Association
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
National Institute of Public Health
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Occupational and Environmental Health
Address
1-1 Iseigaoka, Yahatanishi, Kitakyusyu, Japan
Tel
093-603-1001
dpvdtrial@mbox.med.uoeh-u.ac.jp
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
産業医科大学（福岡県）、小倉医師会健診センター（福岡県）、藤沢市民病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 04 | Month | 07 | Day |
Related information
URL releasing protocol
http://www.shinkomonji-hp.jp/
Publication of results
Partially published
Result
URL related to results and publications
https://www.bmj.com/content/377/bmj-2021-066222
Number of participants that the trial has enrolled
1256
Results
During a median follow-up of 2.9 years, 79 (12.5%) of 630 participants in the eldecalcitol group and 89 (14.2%) of 626 in the placebo group developed type 2 diabetes (HR 0.87, 95%CI 0.67 to 1.17, P=0.39). After adjustment for confounding factors by multivariable fractional polynomial Cox regression analysis, eldecalcitol significantly lowered the development of diabetes (HR 0.69, 0.51 to 0.95, P=0.020).
Results date posted
| 2023 | Year | 01 | Month | 04 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2023 | Year | 07 | Month | 01 | Day |
Baseline Characteristics
Of the 1256 participants, 571 (45.5%) were women and 742 (59.1%) had a family history of type 2 diabetes. The mean age of participants was 61.3 years. The mean serum 25-hydroxyvitamin D concentration at baseline was 20.9 ng/mL (52.2 nmol/L); 548 (43.6%) participants had concentrations below 20 ng/mL (50 nmol/L). A median follow-up duration was 2.9 years.
Participant flow
Study visits were scheduled at three month intervals, with the follow-up period concluding after three years. A routine clinical examination, including measurement of fasting plasma glucose and glycated haemoglobin, was performed at each study visit. Each participant received a brief (five to 10 minutes long) talk on appropriate calorie intake from diet and exercise at each study visit, using an information sheet. A 75 g oral glucose tolerance test, serum 25-hydroxyvitamin D and 1,25-dihydroxyvitamin D concentrations, and bone mineral density were measured at baseline and at yearly intervals. Serum 25-hydroxyvitamin D and 1,25-dihydroxyvitamin D concentrations were measured by liquid chromatography-tandem mass spectrometry at LSI Medience Corporation (Tokyo, Japan). All data were collected in the assignment centre.
Adverse events
A total of 26 (4.1%) participants in the eldecalcitol group and 21 (3.4%) in the placebo group discontinued the study owing to adverse events (hazard ratio 1.23, 0.70 to 2.16; P=0.47). Rates and types of adverse events did not differ significantly between the two groups.
Outcome measures
The primary endpoint is the development of sarcopenia. Sarcopenia is defined as meeting both of the following criteria: weak handgrip strength (<28 kg for men and <18 kg for women) and low appendicular skeletal muscle mass index (<7.0 kg/m2 for men and <5.7 kg/m2 for women in bioelectrical impedance analysis) based on the definition of the Asian Working Group for Sarcopenia.
Secondary endpoints are percent changes in body mass index (BMI), waist circumference, body fat percentage, fat mass index, lean mass index, appendicular skeletal muscle index, and handgrip strength during the 3-year study period. In subgroup 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.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2008 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2013 | Year | 05 | Month | 20 | Day |
Anticipated trial start date
| 2013 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 04 | Month | 07 | Day |
Last modified on
| 2023 | Year | 01 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006404
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