Efficacy Study of Vitamin D and Statins to Treat Hypercholesterolemia

This study is currently recruiting participants.
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
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 April 17, 2014