Rationale and design of Diabetes Prevention with active Vitamin D (DPVD): a randomised, double-blind, placebo-controlled study
Introduction Recent research suggests that vitamin D deficiency may cause both bone diseases and a range of non-skeletal diseases. However, most of these data come from observational studies, and clinical trial data on the effects of vitamin D supplementation on individuals with pre-diabetes are sca...
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BMJ Publishing Group
2016-07-01
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| Series: | BMJ Open |
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| author | Yoshiya Tanaka Yosuke Okada Tetsuya Kawahara Gen Suzuki Tetsuya Inazu Shoichi Mizuno Fumiyoshi Kasagi |
| author_facet | Yoshiya Tanaka Yosuke Okada Tetsuya Kawahara Gen Suzuki Tetsuya Inazu Shoichi Mizuno Fumiyoshi Kasagi |
| author_sort | Yoshiya Tanaka |
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| description | Introduction Recent research suggests that vitamin D deficiency may cause both bone diseases and a range of non-skeletal diseases. However, most of these data come from observational studies, and clinical trial data on the effects of vitamin D supplementation on individuals with pre-diabetes are scarce and inconsistent. The aim of the Diabetes Prevention with active Vitamin D (DPVD) study is to assess the effect of eldecalcitol, active vitamin D analogue, on the incidence of type 2 diabetes among individuals with pre-diabetes.Methods and analysis DPVD is an ongoing, prospective, multicentre, randomised, double-blind and placebo-controlled outcome study in individuals with impaired glucose tolerance. Participants, men and women aged ≥30 years, will be randomised to receive eldecalcitol or placebo. They will also be given a brief (5–10 min long) talk about appropriate calorie intake from diet and exercise at each 12-week visit. The primary end point is the cumulative incidence of type 2 diabetes. Secondary endpoint is the number of participants who achieve normoglycaemia at 48, 96 and 144 weeks. Follow-up is estimated to span 144 weeks.Ethics and dissemination All protocols and an informed consent form comply with the Ethics Guideline for Clinical Research (Japan Ministry of Health, Labour and Welfare). The study protocol has been approved by the Institutional Review Board at Kokura Medical Association and University of Occupational and Environmental Health. The study will be implemented in line with the CONSORT statement.Trial registration number UMIN000010758; Pre-results. |
| format | Article |
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| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2016-07-01 |
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| spelling | doaj-art-e2b4ee800c524f4a918b05686c33fff72025-02-01T16:05:09ZengBMJ Publishing GroupBMJ Open2044-60552016-07-016710.1136/bmjopen-2016-011183Rationale and design of Diabetes Prevention with active Vitamin D (DPVD): a randomised, double-blind, placebo-controlled studyYoshiya Tanaka0Yosuke Okada1Tetsuya Kawahara2Gen Suzuki3Tetsuya Inazu4Shoichi Mizuno5Fumiyoshi Kasagi635 First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan5First Department of Internal Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan1Department of Internal Medicine, Kokura Medical Association Health Testing Center, Kitakyushu, Japan2Department of Internal Medicine, International University of Health and Welfare Clinic, Ohtawara, Japan3Department of Pharmacy, College of Pharmaceutical Sciences, Ritsumeikan University, Kusatsu, Japan4Department of Epidemiology, Radiation Effects Association, Tokyo, Japanassistant department chiefIntroduction Recent research suggests that vitamin D deficiency may cause both bone diseases and a range of non-skeletal diseases. However, most of these data come from observational studies, and clinical trial data on the effects of vitamin D supplementation on individuals with pre-diabetes are scarce and inconsistent. The aim of the Diabetes Prevention with active Vitamin D (DPVD) study is to assess the effect of eldecalcitol, active vitamin D analogue, on the incidence of type 2 diabetes among individuals with pre-diabetes.Methods and analysis DPVD is an ongoing, prospective, multicentre, randomised, double-blind and placebo-controlled outcome study in individuals with impaired glucose tolerance. Participants, men and women aged ≥30 years, will be randomised to receive eldecalcitol or placebo. They will also be given a brief (5–10 min long) talk about appropriate calorie intake from diet and exercise at each 12-week visit. The primary end point is the cumulative incidence of type 2 diabetes. Secondary endpoint is the number of participants who achieve normoglycaemia at 48, 96 and 144 weeks. Follow-up is estimated to span 144 weeks.Ethics and dissemination All protocols and an informed consent form comply with the Ethics Guideline for Clinical Research (Japan Ministry of Health, Labour and Welfare). The study protocol has been approved by the Institutional Review Board at Kokura Medical Association and University of Occupational and Environmental Health. The study will be implemented in line with the CONSORT statement.Trial registration number UMIN000010758; Pre-results.https://bmjopen.bmj.com/content/6/7/e011183.full |
| spellingShingle | Yoshiya Tanaka Yosuke Okada Tetsuya Kawahara Gen Suzuki Tetsuya Inazu Shoichi Mizuno Fumiyoshi Kasagi Rationale and design of Diabetes Prevention with active Vitamin D (DPVD): a randomised, double-blind, placebo-controlled study BMJ Open |
| title | Rationale and design of Diabetes Prevention with active Vitamin D (DPVD): a randomised, double-blind, placebo-controlled study |
| title_full | Rationale and design of Diabetes Prevention with active Vitamin D (DPVD): a randomised, double-blind, placebo-controlled study |
| title_fullStr | Rationale and design of Diabetes Prevention with active Vitamin D (DPVD): a randomised, double-blind, placebo-controlled study |
| title_full_unstemmed | Rationale and design of Diabetes Prevention with active Vitamin D (DPVD): a randomised, double-blind, placebo-controlled study |
| title_short | Rationale and design of Diabetes Prevention with active Vitamin D (DPVD): a randomised, double-blind, placebo-controlled study |
| title_sort | rationale and design of diabetes prevention with active vitamin d dpvd a randomised double blind placebo controlled study |
| url | https://bmjopen.bmj.com/content/6/7/e011183.full |
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