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Efficacy Study of Vitamin D and Statins to Treat Hypercholesterolemia

Primary Purpose

Primary Hypercholesterolemia

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
vitamin D3 tablets
placebo tablets
Sponsored by
Shi Yang
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Hypercholesterolemia focused on measuring hypercholesterolemia; vitamin D; adjuvant therapy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • PLA General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Vitamin D supplementation group

Control group

Arm Description

drug: vitamin D3 tablets (Vigantoletten; Merck Pharma, Germany); the frequency: 2000 IU vitamin D3 tablets were taken daily; duration: 6 months.

drug: placebo tablets; the frequency: 2000 IU placebo tablets were taken daily; duration: 6 months.

Outcomes

Primary Outcome Measures

a change in serum total cholesterol level
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
The change in serum triglycerides level was measured after 6 months of vitamin D supplementation.
differences in the incidences of treatment-emergent adverse events
Treatment-emergent adverse events (TEAEs): hypercalcemia, renal insufficiency, constipation

Full Information

First Posted
December 9, 2013
Last Updated
December 9, 2013
Sponsor
Shi Yang
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1. Study Identification

Unique Protocol Identification Number
NCT02009787
Brief Title
Efficacy Study of Vitamin D and Statins to Treat Hypercholesterolemia
Official Title
Effect of Vitamin D and Statins on Plasma Lipid Profiles in Chinese Patients With Hypercholesterolemia
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Unknown status
Study Start Date
December 2013 (undefined)
Primary Completion Date
January 2015 (Anticipated)
Study Completion Date
January 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Shi Yang

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Hypercholesterolemia
Keywords
hypercholesterolemia; vitamin D; adjuvant therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
56 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Vitamin D supplementation group
Arm Type
Experimental
Arm Description
drug: vitamin D3 tablets (Vigantoletten; Merck Pharma, Germany); the frequency: 2000 IU vitamin D3 tablets were taken daily; duration: 6 months.
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
drug: placebo tablets; the frequency: 2000 IU placebo tablets were taken daily; duration: 6 months.
Intervention Type
Drug
Intervention Name(s)
vitamin D3 tablets
Other Intervention Name(s)
Vigantoletten; Merck Pharma, Germany
Intervention Description
2000 IU vitamin D3 tablets were taken daily for 6 months
Intervention Type
Drug
Intervention Name(s)
placebo tablets
Intervention Description
2000 IU placebo tablets were taken daily for 6 months
Primary Outcome Measure Information:
Title
a change in serum total cholesterol level
Description
The primary end point was a change in serum total cholesterol level after 6 months of vitamin D supplementation.
Time Frame
after 6 months of vitamin D supplementation
Secondary Outcome Measure Information:
Title
a change in serum triglycerides level
Description
The change in serum triglycerides level was measured after 6 months of vitamin D supplementation.
Time Frame
after 6 months of vitamin D supplementation
Title
differences in the incidences of treatment-emergent adverse events
Description
Treatment-emergent adverse events (TEAEs): hypercalcemia, renal insufficiency, constipation
Time Frame
after 6 months of vitamin D supplementation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yang Shi, M.D.
Phone
+8610-66876231
Email
ggyyong@sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yu Tang Wang, M.D.
Organizational Affiliation
PLA General Hospital
Official's Role
Study Director
Facility Information:
Facility Name
PLA General Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100853
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yang Shi, M.D.
Phone
+8610-66876231
Email
ggyyong@sina.com
First Name & Middle Initial & Last Name & Degree
Yu Tang Wang, M.D.

12. IPD Sharing Statement

Citations:
PubMed Identifier
19091317
Citation
Kendrick J, Targher G, Smits G, Chonchol M. 25-Hydroxyvitamin D deficiency is independently associated with cardiovascular disease in the Third National Health and Nutrition Examination Survey. Atherosclerosis. 2009 Jul;205(1):255-60. doi: 10.1016/j.atherosclerosis.2008.10.033. Epub 2008 Nov 11.
Results Reference
background
PubMed Identifier
17624643
Citation
Botella-Carretero JI, Alvarez-Blasco F, Villafruela JJ, Balsa JA, Vazquez C, Escobar-Morreale HF. Vitamin D deficiency is associated with the metabolic syndrome in morbid obesity. Clin Nutr. 2007 Oct;26(5):573-80. doi: 10.1016/j.clnu.2007.05.009. Epub 2007 Jul 10.
Results Reference
background
PubMed Identifier
22986625
Citation
Skaaby T, Husemoen LL, Pisinger C, Jorgensen T, Thuesen BH, Fenger M, Linneberg A. Vitamin D status and changes in cardiovascular risk factors: a prospective study of a general population. Cardiology. 2012;123(1):62-70. doi: 10.1159/000341277. Epub 2012 Sep 12.
Results Reference
background
PubMed Identifier
22947589
Citation
Ponda MP, Dowd K, Finkielstein D, Holt PR, Breslow JL. The short-term effects of vitamin D repletion on cholesterol: a randomized, placebo-controlled trial. Arterioscler Thromb Vasc Biol. 2012 Oct;32(10):2510-5. doi: 10.1161/ATVBAHA.112.254110. Epub 2012 Sep 4.
Results Reference
background
PubMed Identifier
18754003
Citation
Schwartz JB. Effects of vitamin D supplementation in atorvastatin-treated patients: a new drug interaction with an unexpected consequence. Clin Pharmacol Ther. 2009 Feb;85(2):198-203. doi: 10.1038/clpt.2008.165. Epub 2008 Aug 27.
Results Reference
result
PubMed Identifier
24844869
Citation
Qin XF, Zhao LS, Chen WR, Yin DW, Wang H. Effects of vitamin D on plasma lipid profiles in statin-treated patients with hypercholesterolemia: A randomized placebo-controlled trial. Clin Nutr. 2015 Apr;34(2):201-6. doi: 10.1016/j.clnu.2014.04.017. Epub 2014 May 2.
Results Reference
derived

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Efficacy Study of Vitamin D and Statins to Treat Hypercholesterolemia

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