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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

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

Condition or disease Intervention/treatment Phase
Primary Hypercholesterolemia Drug: vitamin D3 tablets Drug: placebo tablets Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Vitamin D and Statins on Plasma Lipid Profiles in Chinese Patients With Hypercholesterolemia
Study Start Date : December 2013
Estimated Primary Completion Date : January 2015
Estimated Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Vitamin D
U.S. FDA Resources

Arm Intervention/treatment
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.
Drug: vitamin D3 tablets
2000 IU vitamin D3 tablets were taken daily for 6 months
Other Name: Vigantoletten; Merck Pharma, Germany
Placebo Comparator: Control group
drug: placebo tablets; the frequency: 2000 IU placebo tablets were taken daily; duration: 6 months.
Drug: placebo tablets
2000 IU placebo tablets were taken daily for 6 months



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02009787


Contacts
Contact: Yang Shi, M.D. +8610-66876231 ggyyong@sina.com

Locations
China, Beijing
PLA General Hospital Recruiting
Beijing, Beijing, China, 100853
Contact: Yang Shi, M.D.    +8610-66876231    ggyyong@sina.com   
Principal Investigator: Yu Tang Wang, M.D.         
Sponsors and Collaborators
Shi Yang
Investigators
Study Director: Yu Tang Wang, M.D. PLA General Hospital

Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Shi Yang, Director of Geriatric Cardiology, Chinese PLA General Hospital
ClinicalTrials.gov Identifier: NCT02009787     History of Changes
Other Study ID Numbers: S2013-098-01
First Posted: December 12, 2013    Key Record Dates
Last Update Posted: December 12, 2013
Last Verified: December 2013

Keywords provided by Shi Yang, Chinese PLA General Hospital:
hypercholesterolemia; vitamin D; adjuvant therapy

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents