NCT02999204

Brief Summary

To evaluate in patients with chronic kidney disease the impact of two dosages of per os vitamin D3 supplementation (cholecalciferol) on large arterial stiffness (evaluated non invasively by pulse wave velocity and high-resolution echotracking system). We will also study arterial calcification (lateral abdominal radiography and echocardiogram), arterial remodeling (high-resolution echotracking system), endothelial function (evaluated by a non-invasive finger biosensor device), and bone remodeling (evaluated by serum biomarkers and bone mineral density).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
57

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2015

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2015

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

August 29, 2016

Completed
4 months until next milestone

First Posted

Study publicly available on registry

December 21, 2016

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 23, 2020

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
Last Updated

February 16, 2021

Status Verified

February 1, 2021

Enrollment Period

5.7 years

First QC Date

August 29, 2016

Last Update Submit

February 12, 2021

Conditions

Renal Insufficiency, ChronicVascular StiffnessBone Diseases, Metabolic

Outcome Measures

Primary Outcomes (1)

  • Aortic stiffness evaluated by pulse wave velocity (PWV) (Sphygmocor ® )

    Parameter measured in meters per second.

    12 months

Secondary Outcomes (6)

  • Carotid stiffness evaluated by high resolution echotracking system (Art-lab®).

    12 months

  • Endothelial function evaluated by Endo-PAT2000® system

    12 months

  • Aortic valve calcification obtained from echocardiography.

    12 months

  • Calcification of the aorta obtained by plain lateral radiography.

    12 months

  • Bone mineral density

    12 months

  • +1 more secondary outcomes

Study Arms (2)

Vitamin D3 5,000 units per week

ACTIVE COMPARATOR

Patient receive a dose that is considered within the standard dosing range for Vitamin D3 for one year.

Drug: Vitamin D3

Vitamin D3 50,000 units per week

EXPERIMENTAL

Patients receive a more aggressive Vitamin D3 dosing regimen of 50,000 units weekly for the first 3 months. At this point Vitamin D3 levels are measured. If the patient is Vitamin D3 replete (\>75 nmol/L) then the dose is reduced to the equivalent of 25,000 units per week for the next 9 months. If the level is below this threshold then 50,000 units per week is continued for the next 9 months

Drug: Vitamin D3

Interventions

Vitamin D3DRUG

Two different doses of Vitamin D3

Also known as: cholecalciferol
Vitamin D3 5,000 units per weekVitamin D3 50,000 units per week

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with CKD stage 3-4 \[estimated glomerular filtration rate (GFR) by modification of diet in renal disease (MDRD) formula between 15 and 60 ml/min/1.73m2\].
  • Serum vitamin D level\<50 nmol/L.

You may not qualify if:

  • Patient with estimated GFR by MDRD formula below 15 or above 60 ml/min/1.73m2).
  • Serum vitamin D level \>50 nmol/L.
  • Liver disease manifested by elevated alanine aminotransferase (ALT) more than 3 times the upper limit of normal reference range, elevated gamma-glutamyl transferase (GGT) and total bilirubin levels.
  • History of malabsorption or chronic diarrhea.
  • Patients on biphosphonates, estrogen replacement therapy, PTH analogs, glucocorticosteroids, calcimimetics, and active vitamin D \[1,25(OH)\].
  • Patients on antiepileptic medications or other medications affecting vitamin D metabolism (e.g. phenobarbital, phenytoin, rifampicin).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jewish General Hospital

Montreal, Quebec, H3T1E2, Canada

Location

Related Publications (6)

  • Guerin AP, Blacher J, Pannier B, Marchais SJ, Safar ME, London GM. Impact of aortic stiffness attenuation on survival of patients in end-stage renal failure. Circulation. 2001 Feb 20;103(7):987-92. doi: 10.1161/01.cir.103.7.987.

    PMID: 11181474RESULT

  • London GM, Guerin AP, Verbeke FH, Pannier B, Boutouyrie P, Marchais SJ, Metivier F. Mineral metabolism and arterial functions in end-stage renal disease: potential role of 25-hydroxyvitamin D deficiency. J Am Soc Nephrol. 2007 Feb;18(2):613-20. doi: 10.1681/ASN.2006060573. Epub 2007 Jan 3.

    PMID: 17202417RESULT

  • 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: 19091317RESULT

  • Motiwala SR, Wang TJ. Vitamin D and cardiovascular disease. Curr Opin Nephrol Hypertens. 2011 Jul;20(4):345-53. doi: 10.1097/MNH.0b013e3283474985.

    PMID: 21519252RESULT

  • Artaza JN, Mehrotra R, Norris KC. Vitamin D and the cardiovascular system. Clin J Am Soc Nephrol. 2009 Sep;4(9):1515-22. doi: 10.2215/CJN.02260409. Epub 2009 Aug 20.

    PMID: 19696220RESULT

  • Barreto DV, Barreto FC, Liabeuf S, Temmar M, Boitte F, Choukroun G, Fournier A, Massy ZA. Vitamin D affects survival independently of vascular calcification in chronic kidney disease. Clin J Am Soc Nephrol. 2009 Jun;4(6):1128-35. doi: 10.2215/CJN.00260109. Epub 2009 May 14.

    PMID: 19443628RESULT

MeSH Terms

Conditions

Renal Insufficiency, ChronicBone Diseases, Metabolic

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Officials

  • Mark L Lipman, M.D.

    Jewish General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine

Study Record Dates

First Submitted

August 29, 2016

First Posted

December 21, 2016

Study Start

January 1, 2015

Primary Completion

September 23, 2020

Study Completion

October 1, 2020

Last Updated

February 16, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)