Efficacy Study of Vitamin D and Statins to Treat Hypercholesterolemia

Not Applicable

• Conditions: Primary Hypercholesterolemia
• Interventions: Drug: vitamin D3 tablets; Drug: placebo tablets

• Registration Number: NCT02009787
• Lead Sponsor: Shi Yang

Brief Summary

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

Detailed Description

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.

Study Timeline

• Status Verified: 2013-12
• Study Start: 2013-12
• Study First Submitted: 2013-12-09
• Study First Submitted QC: 2013-12-09
• Last Update Submitted: 2013-12-09
• Study First Posted: 2013-12-12
• Last Update Posted: 2013-12-12
• Primary Completion: 2015-01
• Study Completion: 2015-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

The main inclusion criteria were for hypercholesterolemia patients with the treatment of statins.

Exclusion Criteria

The exclusion criteria were as follows: patients with chronic renal failure, chronic liver disease, bone disorders, and/or thyroid disorders. Patients were also excluded if they were taking vitamin D3 tablets or other lipid-regulating drugs.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vitamin D supplementation group	vitamin D3 tablets	drug: vitamin D3 tablets (Vigantoletten; Merck Pharma, Germany); the frequency: 2000 IU vitamin D3 tablets were taken daily; duration: 6 months.
Control group	placebo tablets	drug: placebo tablets; the frequency: 2000 IU placebo tablets were taken daily; duration: 6 months.

Primary Outcome Measures

Name	Time	Method
a change in serum total cholesterol level	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.

Secondary Outcome Measures

Name	Time	Method
a change in serum triglycerides level	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	after 6 months of vitamin D supplementation	Treatment-emergent adverse events (TEAEs): hypercalcemia, renal insufficiency, constipation

Trial Locations

Locations (1)

PLA General Hospital; 🇨🇳 Beijing, Beijing, China