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van CCT (UK)

van CCT (UK)

Vitamin C status in patients with chronic kidney failure

- candidate number18244
- NTR NumberNTR4677
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR30-jun-2014
- Secondary IDs2014/033 METC
- Public TitleVitamin C status in patients with chronic kidney failure
- Scientific TitleVitamin C status in patients with chronic kidney failure
- hypothesisVitamin C deficiency may play a role in the symptoms of patients with chronic kidney failure and eventually renal replacement therapy
- Healt Condition(s) or Problem(s) studiedRenal disease, Vitamin C
- Inclusion criteria- minimal 18 years old patients - Predialysis patients: min. 3 months a creatinine clearance of < 20 ml/min
- Transplantation patients: min. 6 months after transplantation and a creatinine clearance > 30 ml/min
- Peritoneal dialysis patients: min. 3 months in treatment
- Conventionel hemodialysis patients: 3x 4 hour/week, min. 3 months in treatment
- Nocturnal in center hemodialysis patients: every other night, min. 3 months in treatment
- Exclusion criteria- malabsorption
- gastro-intestinal disorders
- oncologic disorders
- absence of informed consent
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- group[default]
- Type[default]
- Studytypeobservational
- planned startdate 1-nov-2014
- planned closingdate1-nov-2015
- Target number of participants140
- InterventionsBloodsamples
- Primary outcomePlasma Vitamin C concentration
- Secondary outcomeVitamine C intake
Dialyses clearance of vitamin C
Other laboratory variables
- Timepoints1 year
- Trial web site
- statusplanned
- Sponsor/Initiator University Medical Center Groningen (UMCG), Dialyse Centrum Groningen (DCG)
- Funding
(Source(s) of Monetary or Material Support)
- Publicationsno
- Brief summaryRationale: Patients with kidney failure have various physical complaints and laboratory abnormalities. Vitamin C deficiency may play a causal role and contribute to cramping, iron deficiency and immunity disorders. Unfortunately, there is scarce information in the literature on vitamin C deficiency and vitamin C intake in patients with kidney failure. Also the exact prevalence of vitamin C deficiency and its related symptoms in patients with kidney failure have not yet been systematically examined. Finally, it is not known what the exact cause of vitamin C deficiency is. It is plausible that various mechanisms play a role and that the intensity of the dialysis treatment is an important factor.
Objective: The goal of this study is to assess the prevalence of vitamin C deficiency in patients with end stage renal disease (Endogenous Creatinin Clearance <20 ml/min) and in patients on various forms of renal replacement therapy: kidney transplantation (NTx), peritoneal dialysis (PD), conventional (CHD) and nocturnal center hemodialysis (NCHD).
Study design: Cross-sectional observational study in different patient groups.
Study population: Predialysis patients, NTx, PD, CHD, and NCHD patients of 18 years or older.
Main study parameters/endpoints: 1. Predialysis patients: plasma vitamin C level; 2. NTx patients: plasma vitamin C level; 3. PD patients: plasma vitamin C level, 4. CHD patients: plasma vitamin C levels before, during and after dialysis; 5. NCHD patients: plasma vitamin C levels before, during and after dialysis. In all groups vitamin C intake will be assessed using a 24-hour recall questionnaire.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: This research has no disadvantages for the participants, except drawing of a limited volume of blood. Blood sampling in predialysis, NTx and PD patients will take place during regular visits to the outpatient clinic and no extra venipuncture is necessary; the total blood volume for these patients is 10 ml (incl. 5 ml for storage). Blood sampling in CHD and NCHD patients is performed during the regular dialysis session. The total blood volume in these patients is 20 ml (3 x 5 ml + 5 ml for storage). The food questionnaires are taken during regular visits and will cost no additional time. Participation in this study will take little to no extra time. The results of the study could contribute to the quality of treatment of the patients.
- Main changes (audit trail)
- RECORD30-jun-2014 - 18-okt-2014

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