Vitamin D levels in chronic kidney disease (CKD)
| ISRCTN | ISRCTN90413758 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN90413758 |
| Secondary identifying numbers | 6247 |
- 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
Scientific
30 Guilford Street
London
WC1N 1EH
United Kingdom
Study information
| Study design | Non-randomised interventional treatment trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | Blood samples taken at 4 weeks |
| Secondary outcome measures | Scans annually or prior to transplant |
| Overall study start date | 01/01/2009 |
| Completion date | 30/09/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 5 Years |
| Upper age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 30; UK Sample Size: 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
- England
- United Kingdom
Study participating centre
Great Ormond Street Hospital for Children
London
WC1N 1EH
United Kingdom
WC1N 1EH
United Kingdom
Sponsor information
Great Ormond Street Hospital for Children (UK)
Hospital/treatment centre
Hospital/treatment centre
30 Guilford Street
London
WC1N 1EH
England
United Kingdom
| Website | http://www.ich.ucl.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/03zydm450 |
Funders
Funder type
Charity
Kidney Research UK (UK)
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
09/08/2016: No publications found, verifying study status with principal investigator.
