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Efficacy Study of Vitamin D and Statins to Treat Hypercholesterolemia

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ClinicalTrials.gov Identifier: NCT02009787
Recruitment Status : Unknown
Verified December 2013 by Shi Yang, Chinese PLA General Hospital.
Recruitment status was:  Recruiting
First Posted : December 12, 2013
Last Update Posted : December 12, 2013
Sponsor:
Information provided by (Responsible Party):
Shi Yang, Chinese PLA General Hospital

December 9, 2013
December 12, 2013
December 12, 2013
December 2013
January 2015   (Final data collection date for primary outcome measure)
a change in serum total cholesterol level [ Time Frame: 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.
Same as current
No Changes Posted
  • a change in serum triglycerides level [ Time Frame: 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 [ Time Frame: after 6 months of vitamin D supplementation ]
    Treatment-emergent adverse events (TEAEs): hypercalcemia, renal insufficiency, constipation
Same as current
Not Provided
Not Provided
 
Efficacy Study of Vitamin D and Statins to Treat Hypercholesterolemia
Effect of Vitamin D and Statins on Plasma Lipid Profiles in Chinese Patients With Hypercholesterolemia
The investigators planned to research the effect of vitamin D supplementation as an adjuvant therapy for patients with hypercholesterolemia.
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.
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Primary Hypercholesterolemia
  • Drug: vitamin D3 tablets
    2000 IU vitamin D3 tablets were taken daily for 6 months
    Other Name: Vigantoletten; Merck Pharma, Germany
  • Drug: placebo tablets
    2000 IU placebo tablets were taken daily for 6 months
  • Experimental: Vitamin D supplementation group
    drug: vitamin D3 tablets (Vigantoletten; Merck Pharma, Germany); the frequency: 2000 IU vitamin D3 tablets were taken daily; duration: 6 months.
    Intervention: Drug: vitamin D3 tablets
  • Placebo Comparator: Control group
    drug: placebo tablets; the frequency: 2000 IU placebo tablets were taken daily; duration: 6 months.
    Intervention: Drug: placebo tablets

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
56
Same as current
January 2015
January 2015   (Final data collection date for primary outcome measure)

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.

Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT02009787
S2013-098-01
Yes
Not Provided
Not Provided
Shi Yang, Chinese PLA General Hospital
Shi Yang
Not Provided
Study Director: Yu Tang Wang, M.D. PLA General Hospital
Chinese PLA General Hospital
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP