Condition category
Urological and Genital Diseases
Date applied
29/04/2010
Date assigned
29/04/2010
Last edited
08/08/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Lesley Rees

ORCID ID

Contact details

30 Guilford Street
London
WC1N 1EH
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

6247

Study information

Scientific title

Vitamin D in children with chronic kidney disease (CKD) on dialysis: a non-randomised interventional treatment pilot study

Acronym

Study hypothesis

The aim of chronic kidney disease mineral and bone disorder (CKD-MBD) management is to maintain normal bone turnover and minimise vascular calcification. Recommendations to achieve this hinge on manipulation of parathyroid hormone (PTH) levels into a specified range using diet, preparations that prevent the absorption of phosphate and the activated form of vitamin D (1-alpha hydroxycholecalciferol or alfacalcidol). However, there is no evidence base for this practise. More recently, the role of vitamin D in cardiovascular disease (CVD) prevention has been demonstrated by ourselves and others. CVD can be studied in children using established surrogate markers such as carotid-intima thickness (cIMT).

Ethics approval

Institute of Child Health/Great Ormond Street Hospital Research Ethics Committee, 2008, ref: 08/H0713/38

Study design

Non-randomised interventional treatment trial

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Topic: Medicines for Children Research Network; Subtopic: All Diagnoses; Disease: All Diseases

Intervention

Baseline 1,25(OH)2D levels will be measured. The alfacalcidol dose will be adjusted so as to keep the serum 1,25(OH)2D level in the normal range (40 – 150 pmol/L). Levels will be checked every 4 weeks so as to ensure that the 1,25(OH)2D level remains normal.

All children who are on dialysis will undergo the following scans annually or prior to transplantation (whichever is sooner):
1. cIMT, using high-resolution ultrasound of both common carotid arteries
2. PWV, using applanation tonometry to measure aortic and brachio-radial pulse wave velocity
3. Coronary artery calcification (CAC) score, using multi-slice CT scan for ECG-gated imaging of the heart

Intervention type

Supplement

Phase

Not Applicable

Drug names

Vitamin D

Primary outcome measures

Blood samples taken at 4 weeks

Secondary outcome measures

Scans annually or prior to transplant

Overall trial start date

01/01/2009

Overall trial end date

30/09/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. 30 children aged 5 to 18 years, either sex
2. CKD stage 5 (estimated glomerular filtration rate [GFR] less than 15 ml/min/1.73 m^2 or on dialysis)

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

Planned Sample Size: 30; UK Sample Size: 30

Participant exclusion criteria

1. Smokers
2. Diabetics
3. Uncontrolled hypertension
4. Inflammatory disorders
5. Receiving anti-epileptic medications
6. Liver disease

Recruitment start date

01/01/2009

Recruitment end date

30/09/2010

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Great Ormond Street Hospital for Children
London
WC1N 1EH
United Kingdom

Sponsor information

Organisation

Great Ormond Street Hospital for Children (UK)

Sponsor details

30 Guilford Street
London
WC1N 1EH
United Kingdom

Sponsor type

Hospital/treatment centre

Website

http://www.ich.ucl.ac.uk/

Funders

Funder type

Charity

Funder name

Kidney Research UK (UK)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

09/08/2016: No publications found, verifying study status with principal investigator.