Primary Hypercholesterolemia
Conditions
Keywords
hypercholesterolemia; vitamin D; adjuvant therapy
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.
Interventions
2000 IU vitamin D3 tablets were taken daily for 6 months
DRUGplacebo tablets
2000 IU placebo tablets were taken daily for 6 months
Sponsors
Shi Yang
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
The main inclusion criteria were for hypercholesterolemia patients with the treatment of statins.
Exclusion criteria
The
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
China
Contacts
Primary ContactYang Shi, M.D.
Outcome results
None listed