ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12611001113943

Ethics application status

Approved

Date submitted

25/10/2011

Date registered

25/10/2011

Date last updated

26/10/2011

Type of registration

Prospectively registered

Titles & IDs

Public title

Effect of vitamin D replacement in patients with chronic kidney disease

Scientific title

Randomised controlled trial to determine the effect of vitamin D replacement on arterial stiffness and cardiometabolic risk factors in vitamin D deficient stage 3-5 chronic kidney disease patients

Secondary ID [1]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Vitamin D deficient stage 3-5 chronic kidney disease, with and without diabetes and pre dialysis

Condition category

Condition code

Renal and Urogenital

Kidney disease

Diet and Nutrition

Other diet and nutrition disorders

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Group 1: 1 tablet is equivalent to 50,000U of cholecalciferol (Vitamin D3). Participants will be required to take 2 oral tablets at randomisation, then 1 oral tablet monthly for 6 months (24 weeks). Participants may be required to increase their dose to one tablet fortnightly between 3- 6 months if their 25OH-VitD blood level is less than 50 nmol/L at 3 months (12 weeks).
Group 2 Placebo. The participants will be required to take the same number of oral placebo tablets as group one.

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

One placebo tablet contains lactose monohydrate NF (spray-dried).

Control group

Placebo

Outcomes

Primary outcome [1]

To assess the effects of cholecalciferol at an initial dose of 100,000U then 50,000U monthly, or matched placebo, for 6 months on arterial stiffness in 25OHD deficient stage 3-5 CKD patients. Cardiovascular risk will be assessed at baseline (week 0) and 6 months (week 24) after starting study medication. Measurements with SphygmoCor system will include:
1. Augmentation index (Alx)
2. Pulse Wave Velocity (PWV)

Timepoint [1]

Measured at baseline (week 0) prior to first dose of cholecalciferol and after 6 months (week 24) treatment

Secondary outcome [1]

Inflammatory markers including interleukins 6, 12 and 18 and C-reactive protein

Timepoint [1]

Measured at baseline (week 0) prior to first dose of cholecalciferol and after 6 months (week 24) treatment

Secondary outcome [2]

Markers of insulin resistance including HOMA score and waist-hip circumference

Timepoint [2]

Measured at baseline (week 0) prior to first dose of cholecalciferol and after 6 months (week 24) treatment

Secondary outcome [3]

Lipid profile

Timepoint [3]

Measured at baseline (week 0) prior to first dose of cholecalciferol and after 6 months (week 24) treatment

Secondary outcome [4]

Markers of bone metabolism

Timepoint [4]

Measured at baseline (week 0) prior to first dose of cholecalciferol and after 6 months (week 24) treatment

Secondary outcome [5]

Change in kidney function (estimated glomerular filtration rate)

Timepoint [5]

Measured at baseline (week 0) prior to first dose of cholecalciferol and after 6 months (week 24) treatment

Secondary outcome [6]

Change in urine proteinuria (determined by spot urine protein/creatinine ratio)

Timepoint [6]

Measured at baseline (week 0) prior to first dose of cholecalciferol and after 6 months (week 24) treatment

Eligibility

Key inclusion criteria

1. ages 18-80 years
2. Vitamin D deficiency (25OHD 15- 75nmol/L)
3. Stage 3-5 CKD, not yet on dialysis (eGFRof < 60mL/min/m2)

Minimum age

18 Years

Maximum age

80 Years

Sex

Both males and females

Can healthy volunteers participate?

No

Key exclusion criteria

1.Serum Calcium > 2.55mmol/L and/ or Phosphate > 1.80mmol/L
2. Severe Calcium deficiency (<15nmol/L)
3. Liver enzymes (Bilirubin, alanine aminotransferase, GGT) > 3 times upper limit of normal
4. Cardiovascular event or unstable cardiovascular disease in preceding 6 months 6 or NYHA heart failure stage III or IV
5. Significant psychiatric disorder
6. Active infection or inflammation
7. Pregnancy/ planning pregnancy
8. Significant proteinuria (= to > 3g/d)

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Randomization will be performed by an authorized person not directly involved in the trial. This authorized person will receive a set of treatment allocation cards with sequential randomization numbers on which the treatment group information is covered by a peel-off label.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

The treatment allocation cards are used to avoid bias in the assignment of the patients to Group 1 and Group 2 in the specified 1:1 ratio by a simple randomisation technique similar to coin-tossing. For diabetic patients, a separate treatment allocation cards with sequential randomization numbers on which the treatment group information is covered by a peel-off label will be provided. Diabetic patients will be stratified to both groups in a sequential manner to ensure similar proportion of high-risk patients in both groups.
.

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Phase 4

Type of endpoint/s

Efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

1/11/2011

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

90

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Sir Charles Gairdner Hospital, Research Advisory Committee

Address [1]

Hospital Ave.
Nedlands, Western Australia, 6009

Country [1]

Australia

Funding source category [2]

Hospital

Name [2]

Department of Renal Medicine, Sir Charles Gairdner Hospital

Address [2]

Hospital Ave.
Nedlands, Western Australia, 6009

Country [2]

Australia

Primary sponsor type

Hospital

Name

Sir Charles Gairdner Hospital Group

Address

Hospital Ave.
Nedlands, Western Australia, 6009

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Sir Charles Gairdner Hospital

Ethics committee address [1]

Hospital Ave.
Nedlands, Western Australia 6009

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

01/10/2010

Approval date [1]

07/04/2011

Ethics approval number [1]

2010-099

Summary

Brief summary

Vitamin D deficiency is common in patients with chronic kidney disease and has been associated with increased risk of heart disease and death. Correcting vitamin D deficiency may improve risk for heart disease through its effects on blood vessel, immune and bone cell function.  Stiffness of the arteries (arterial stiffness) is associated with increased risk of heart disease and can be measured using simple non-invasive methods.  The effect of vitamin D replacement on arterial stiffness has not previously been studied in patients with kidney disease.  
This study will examine the effect of vitamin D, a commonly used over-the-counter medication, compared with placebo (“dummy tablet”) on blood vessel function in people with moderate to severe chronic kidney disease who are vitamin D deficient.  In this study, you will be randomly assigned (”like flipping a coin”) to take either vitamin D or placebo (1 tablet monthly) for 6 months.  If at 3 months, your vitamin D levels remain low, you may need to take the study medications every 2 weeks till the end of the study.
Both the vitamin D and placebo medication will be supplied by  a specialist compounding pharmacy with a state of the art compounding laboratory and is accredited by the Pharmacy Guild of Australia as a quality care pharmacy and as such operates under a quality care program.
If you enter the full study, you will have blood tests and blood vessel function studies before you start and after you complete the study medication. During the study, you will not know which treatment you are on. Your other medications will remain constant.  The study requires you to attend the Research Unit at Sir Charles Gairdner Hospital 4 times over a 6-month period.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Email

Contact person for public queries

Name

Dr Wai Lim

Address

Department of Renal Medicine
Sir Charles Gairdner Hospital
Hospital Avenue
Nedlands, western Australia, 6009

Country

Australia

Phone

+61 8 9346 2799

Fax

+61 8 9346 3942

Email

Wai.Lim@health.wa.gov.au

Contact person for scientific queries

Name

Dr. wai lim

Address

Department of Renal Medicine
Sir Charles Gairdner Hospital
Hospital Avenue
Nedlands, western Australia, 6009

Country

Australia

Phone

+61 8 9346 2799

Fax

+61 8 9346 3942

Email

Wai.Lim@health.wa.gov.au

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.