Vitamin D levels in chronic kidney disease (CKD)

ISRCTN	ISRCTN90413758
DOI	https://doi.org/10.1186/ISRCTN90413758
Protocol serial number	6247
Sponsor	Great Ormond Street Hospital for Children (UK)
Funder	Kidney Research UK (UK)

Submission date: 29/04/2010
Registration date: 29/04/2010
Last edited: 08/08/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Urological and Genital Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Lesley Rees
Scientific

30 Guilford Street
London
WC1N 1EH
United Kingdom

Study information

Primary study design	Interventional
Study design	Non-randomised interventional treatment trial
Secondary study design	Non randomised study
Study type	Participant information sheet
Scientific title	Vitamin D in children with chronic kidney disease (CKD) on dialysis: a non-randomised interventional treatment pilot study
Study objectives	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(s)	Institute of Child Health/Great Ormond Street Hospital Research Ethics Committee, 2008, ref: 08/H0713/38
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Blood samples taken at 4 weeks
Key secondary outcome measure(s)	Scans annually or prior to transplant
Completion date	30/09/2010

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	5 Years
Upper age limit	18 Years
Sex	All
Target sample size at registration	30
Key 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)
Key exclusion criteria	1. Smokers 2. Diabetics 3. Uncontrolled hypertension 4. Inflammatory disorders 5. Receiving anti-epileptic medications 6. Liver disease
Date of first enrolment	01/01/2009
Date of final enrolment	30/09/2010

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Great Ormond Street Hospital for Children

London
WC1N 1EH
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

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