Efficacy Study of Vitamin D and Statins to Treat Hypercholesterolemia

Shi Yang

Status: Unknown

Conditions: Primary Hypercholesterolemia

Treatments: Drug: placebo tablets; Drug: vitamin D3 tablets

Study type: Interventional

Funder types: Other

Identifiers

NCT02009787

S2013-098-01

Details and patient eligibility

About

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

Full 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.

Enrollment: 56 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

56 participants in 2 patient groups, including a placebo group

Vitamin D supplementation group

Experimental group

Description:

drug: vitamin D3 tablets (Vigantoletten; Merck Pharma, Germany); the frequency: 2000 IU vitamin D3 tablets were taken daily; duration: 6 months.

Treatment:

Drug: vitamin D3 tablets

Control group

Placebo Comparator group

Description:

drug: placebo tablets; the frequency: 2000 IU placebo tablets were taken daily; duration: 6 months.

Treatment:

Drug: placebo tablets