Efficacy Study of Vitamin D and Statins to Treat Hypercholesterolemia

Primary Hypercholesterolemia Clinical Trial

Official title:

Effect of Vitamin D and Statins on Plasma Lipid Profiles in Chinese Patients With Hypercholesterolemia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02009787
• Other study ID #: S2013-098-01
• Status: Recruiting
• Phase: N/A
• First received: December 9, 2013
• Last updated: December 9, 2013
• Start date: December 2013
• Est. completion date: January 2015

Study information

• Verified date: December 2013
• Source: Chinese PLA General Hospital
• Contact: Yang Shi, M.D.
• Phone: +8610-66876231
• Email: ggyyong[@]sina.com
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationChina: State Administration of Traditional Chinese Medicine of the People's Republic of ChinaChina: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 56
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypercholesterolemia
• Primary Hypercholesterolemia

Intervention

Drug:
• vitamin D3 tablets
2000 IU vitamin D3 tablets were taken daily for 6 months
• placebo tablets
2000 IU placebo tablets were taken daily for 6 months

Locations

Country	Name	City	State
China	PLA General Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Shi Yang

Country where clinical trial is conducted

China, 

References & Publications (5)

Botella-Carretero JI, Alvarez-Blasco F, Villafruela JJ, Balsa JA, Vázquez C, Escobar-Morreale HF. Vitamin D deficiency is associated with the metabolic syndrome in morbid obesity. Clin Nutr. 2007 Oct;26(5):573-80. Epub 2007 Jul 10. — View 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. — View 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. — View 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. — View Citation

Skaaby T, Husemoen LL, Pisinger C, Jørgensen 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	after 6 months of vitamin D supplementation	No
Secondary	a change in serum triglycerides level	The change in serum triglycerides level was measured after 6 months of vitamin D supplementation.	after 6 months of vitamin D supplementation	No
Secondary	differences in the incidences of treatment-emergent adverse events	Treatment-emergent adverse events (TEAEs): hypercalcemia, renal insufficiency, constipation	after 6 months of vitamin D supplementation	Yes