NCT02009787

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2013

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2013

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

December 9, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 12, 2013

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

December 12, 2013

Status Verified

December 1, 2013

Enrollment Period

1.1 years

First QC Date

December 9, 2013

Last Update Submit

December 9, 2013

Conditions

Primary Hypercholesterolemia

Keywords

hypercholesterolemia; vitamin D; adjuvant therapy

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • a change in serum triglycerides level

    after 6 months of vitamin D supplementation

  • differences in the incidences of treatment-emergent adverse events

    after 6 months of vitamin D supplementation

Study Arms (2)

Vitamin D supplementation group

EXPERIMENTAL

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

Control group

PLACEBO COMPARATOR

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

Drug: placebo tablets

Interventions

vitamin D3 tabletsDRUG

2000 IU vitamin D3 tablets were taken daily for 6 months

Also known as: Vigantoletten; Merck Pharma, Germany
Vitamin D supplementation group
placebo tabletsDRUG

2000 IU placebo tablets were taken daily for 6 months

Control group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PLA General Hospital

Beijing, Beijing Municipality, 100853, China

RECRUITING

Related Publications (6)

  • 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.

    PMID: 19091317BACKGROUND

  • 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.

    PMID: 17624643BACKGROUND

  • 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.

    PMID: 22986625BACKGROUND

  • 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.

    PMID: 22947589BACKGROUND

  • 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.

    PMID: 18754003RESULT

  • 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.

    PMID: 24844869DERIVED

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Officials

  • Yu Tang Wang, M.D.

    PLA General Hospital

    STUDY DIRECTOR

Central Study Contacts

Yang Shi, M.D.

CONTACT

+8610-66876231ggyyong@sina.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director of Geriatric Cardiology

Study Record Dates

First Submitted

December 9, 2013

First Posted

December 12, 2013

Study Start

December 1, 2013

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

December 12, 2013

Record last verified: 2013-12

Locations

CN(1)