Efficacy Study of Vitamin D and Statins to Treat Hypercholesterolemia

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

Detailed Description
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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.

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

Conditions
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Primary Hypercholesterolemia

Intervention / Treatment
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* Drug: vitamin D3 tablets
* Drug: placebo tablets


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vitamin D supplementation group<br>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<br>* 2000 IU vitamin D3 tablets were taken daily for 6 months<br>* Other names: Vigantoletten; Merck Pharma, Germany;|
| Placebo Comparator: Control group<br>drug: placebo tablets; the frequency: 2000 IU placebo tablets were taken daily; duration: 6 months. | Drug: placebo tablets<br>* 2000 IU placebo tablets were taken daily for 6 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| a change in serum total cholesterol level | The primary end point was a change in serum total cholesterol level after 6 months of vitamin D supplementation. | after 6 months of vitamin D supplementation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| a change in serum triglycerides level | The change in serum triglycerides level was measured after 6 months of vitamin D supplementation. | after 6 months of vitamin D supplementation | 
| differences in the incidences of treatment-emergent adverse events | Treatment-emergent adverse events (TEAEs): hypercalcemia, renal insufficiency, constipation | after 6 months of vitamin D supplementation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hypercholesterolemia; vitamin D; adjuvant therapy