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Efficacy Study of Vitamin D and Statins to Treat Hypercholesterolemia

NCT ID: NCT02009787

Last Updated: 2013-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2015-01-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Primary Hypercholesterolemia

Keywords

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hypercholesterolemia; vitamin D; adjuvant therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

vitamin D3 tablets

Intervention Type DRUG

2000 IU vitamin D3 tablets were taken daily for 6 months

Control group

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

Group Type PLACEBO_COMPARATOR

placebo tablets

Intervention Type DRUG

2000 IU placebo tablets were taken daily for 6 months

Interventions

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vitamin D3 tablets

2000 IU vitamin D3 tablets were taken daily for 6 months

Intervention Type DRUG

placebo tablets

2000 IU placebo tablets were taken daily for 6 months

Intervention Type DRUG

Other Intervention Names

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Vigantoletten; Merck Pharma, Germany

Eligibility Criteria

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Inclusion 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shi Yang

OTHER

Sponsor Role lead

Responsible Party

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Shi Yang

Director of Geriatric Cardiology

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Yu Tang Wang, M.D.

Role: STUDY_DIRECTOR

PLA General Hospital

Locations

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PLA General Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yang Shi, M.D.

Role: CONTACT

Phone: +8610-66876231

Email: [email protected]

Facility Contacts

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Yang Shi, M.D.

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 19091317 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17624643 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22986625 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22947589 (View on PubMed)

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.

Reference Type RESULT
PMID: 18754003 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24844869 (View on PubMed)

Other Identifiers

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S2013-098-01

Identifier Type: -

Identifier Source: org_study_id