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Efficacy Study of Vitamin D and Statins to Treat Hypercholesterolemia

S

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

Trial contacts and locations

1

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Central trial contact

Yang Shi, M.D.

Data sourced from clinicaltrials.gov

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