Efficacy Study of Vitamin D and Statins to Treat Hypercholesterolemia

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Chinese PLA General Hospital
Sponsor:
Information provided by (Responsible Party):
Shi Yang, Chinese PLA General Hospital
ClinicalTrials.gov Identifier:
NCT02009787
First received: December 9, 2013
Last updated: NA
Last verified: December 2013
History: No changes posted
  Purpose

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


Condition Intervention
Primary Hypercholesterolemia
Drug: vitamin D3 tablets
Drug: placebo tablets

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Vitamin D and Statins on Plasma Lipid Profiles in Chinese Patients With Hypercholesterolemia

Resource links provided by NLM:


Further study details as provided by Chinese PLA General Hospital:

Primary Outcome Measures:
  • a change in serum total cholesterol level [ Time Frame: after 6 months of vitamin D supplementation ] [ Designated as safety issue: No ]
    The primary end point was a change in serum total cholesterol level after 6 months of vitamin D supplementation.


Secondary Outcome Measures:
  • a change in serum triglycerides level [ Time Frame: after 6 months of vitamin D supplementation ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    Treatment-emergent adverse events (TEAEs): hypercalcemia, renal insufficiency, constipation


Estimated Enrollment: 56
Study Start Date: December 2013
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: placebo tablets

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications:
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
Study First Received: December 9, 2013
Last Updated: December 9, 2013
Health Authority: United States: Food and Drug Administration
China: State Administration of Traditional Chinese Medicine of the People's Republic of China
China: Ethics Committee

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

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

ClinicalTrials.gov processed this record on August 28, 2014