Efficacy Study of Vitamin D and Statins to Treat Hypercholesterolemia
|ClinicalTrials.gov Identifier: NCT02009787|
Recruitment Status : Unknown
Verified December 2013 by Shi Yang, Chinese PLA General Hospital.
Recruitment status was: Recruiting
First Posted : December 12, 2013
Last Update Posted : December 12, 2013
|Condition or disease||Intervention/treatment||Phase|
|Primary Hypercholesterolemia||Drug: vitamin D3 tablets Drug: placebo tablets||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||56 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Effect of Vitamin D and Statins on Plasma Lipid Profiles in Chinese Patients With Hypercholesterolemia|
|Study Start Date :||December 2013|
|Estimated Primary Completion Date :||January 2015|
|Estimated Study Completion Date :||January 2015|
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
- a change in serum total cholesterol level [ Time Frame: after 6 months of vitamin D supplementation ]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 ]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 ]Treatment-emergent adverse events (TEAEs): hypercalcemia, renal insufficiency, constipation
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02009787
|Contact: Yang Shi, M.D.||+email@example.com|
|PLA General Hospital||Recruiting|
|Beijing, Beijing, China, 100853|
|Contact: Yang Shi, M.D. +8610-66876231 firstname.lastname@example.org|
|Principal Investigator: Yu Tang Wang, M.D.|
|Study Director:||Yu Tang Wang, M.D.||PLA General Hospital|