Clinical Trial: Efficacy Study of Vitamin D and Statins to Treat Hypercholesterolemia

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Effect of Vitamin D and Statins on Plasma Lipid Profiles in Chinese Patients With Hypercholesterolemia

Brief Summary: The investigators planned to research the effect of vitamin D supplementation as an adjuvant therapy for patients with hypercholesterolemia.

Detailed Summary: 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.
Sponsor: Shi Yang

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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


Original Secondary Outcome: Same as current

Information By: Chinese PLA General Hospital

Dates:
Date Received: December 9, 2013
Date Started: December 2013
Date Completion: January 2015
Last Updated: December 9, 2013
Last Verified: December 2013