Efficacy Study of Vitamin D and Statins to Treat Hypercholesterolemia
The investigators planned to research the effect of vitamin D supplementation as an adjuvant therapy for patients with hypercholesterolemia.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Effect of Vitamin D and Statins on Plasma Lipid Profiles in Chinese Patients With Hypercholesterolemia|
- a change in serum total cholesterol level [ Time Frame: after 6 months of vitamin D supplementation ] [ Designated as safety issue: No ]The primary end point was a change in serum total cholesterol level after 6 months of vitamin D supplementation.
- a change in serum triglycerides level [ Time Frame: after 6 months of vitamin D supplementation ] [ Designated as safety issue: No ]The change in serum triglycerides level was measured after 6 months of vitamin D supplementation.
- differences in the incidences of treatment-emergent adverse events [ Time Frame: after 6 months of vitamin D supplementation ] [ Designated as safety issue: Yes ]Treatment-emergent adverse events (TEAEs): hypercalcemia, renal insufficiency, constipation
|Study Start Date:||December 2013|
|Estimated Study Completion Date:||January 2015|
|Estimated Primary Completion Date:||January 2015 (Final data collection date for primary outcome measure)|
Experimental: Vitamin D supplementation group
drug: vitamin D3 tablets (Vigantoletten; Merck Pharma, Germany); the frequency: 2000 IU vitamin D3 tablets were taken daily; duration: 6 months.
Drug: vitamin D3 tablets
2000 IU vitamin D3 tablets were taken daily for 6 months
Other Name: Vigantoletten; Merck Pharma, Germany
Placebo Comparator: Control group
drug: placebo tablets; the frequency: 2000 IU placebo tablets were taken daily; duration: 6 months.
Drug: placebo tablets
2000 IU placebo tablets were taken daily for 6 months
Other Name: placebo tablets
Vitamin D is primarily generated in the skin, in response to direct absorption of ultraviolet B radiation. Vitamin D can also be obtained through fortified foods and oral supplements. Lipid abnormalities are common in the general population, and are regarded as a modifiable risk factor for cardiovascular disease. Recently low vitamin D status has been shown to be associated with increased risk of developing hyperlipidemia. Statins are normally the first-line therapy for hypercholesterolemia. It is also reported that vitamin D can improve serum lipid levels. However, its effects on hypercholesterolemia patients remain unclear. The investigators planned to determine the efficacy of combination therapy with statins and vitamin D in a cohort of hypercholesterolemia patients. This study may shed light as to whether oral vitamin D supplementation can be an adjunct therapy in hypercholesterolemia patients.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02009787
|Contact: Yang Shi, M.D.||+firstname.lastname@example.org|
|PLA General Hospital||Recruiting|
|Beijing, Beijing, China, 100853|
|Contact: Yang Shi, M.D. +8610-66876231 email@example.com|
|Principal Investigator: Yu Tang Wang, M.D.|
|Study Director:||Yu Tang Wang, M.D.||PLA General Hospital|