The goal of this study is to assess the prevalence of vitamin C deficiency in patients with end stage renal disease (Endogenous Creatinin Clearance (ECC) 30 ml/min) (NTx), peritoneal dialysis (PD), conventional (CHD) and nocturnal in-center…
ID
Source
Brief title
Condition
- Vitamin related disorders
- Renal disorders (excl nephropathies)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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.
Secondary outcome
CHD (3 dialysate measurements),
- vitamin C measurements from the dialysate: 15 minutes after start dialysis,
after 2 hours dialysis, and 15 minutes before the end of the dialysis treatment.
- total Kt/V (dialysis efficiency).
NCHD (4 dialysate measurements),
- vitamin C measurements from the dialysate: 15 minutes after start dialysis,
after 3 hours dialysis, after 6 hours dialysis, and 15 minutes before the end
of the dialysis treatment.
- total Kt/V (dialysis effciency).
Laboratory measurements: Hemoglobin, sodium, potassium, urea, creatinine,
alkaline phosphatase, calcium, phosphate, albumin, ferritin, TSAT, CRP, PTH
(standard monthly measurements)
Background summary
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.
Study 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 (ECC) <20
ml/min) and in patients on various forms of renal replacement therapy: kidney
transplantation (ECC >30 ml/min) (NTx), peritoneal dialysis (PD), conventional
(CHD) and nocturnal in-center hemodialysis (NCHD).
Study design
Cross-sectional observational study in different patient groups.
Study burden and risks
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.
Hanzeplein, ingang 47 1
Groningen 9713GZ
NL
Hanzeplein, ingang 47 1
Groningen 9713GZ
NL
Listed location countries
Age
Inclusion criteria
Predialysis patients with minimal 3 months ECC <= 20 ml/min
Kidney transplantation patients: minimal 6 months after kidney transplantion with ECC >= 30 ml/min
PD patients: minimal 3 months peritoneal dialysis treatment
CHD patients: 3 x per week 4 hours dialysis (± 12 hours dialysis per week), minimal 3 months hemodialysis treatment
NCHD patients: every other night 8 hours dialysis (± 28 hours dialysis per week), minimal 3 months in nocturnal hemodialysis treatment
Exclusion criteria
Malabsorption, gastro intestinal diseasese, oncological diseases, and absence of informed consent.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL47374.042.14 |