Efficacy Study of Vitamin D and Statins to Treat Hypercholesterolemia
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|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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|