Randomized controlled trial on the effect of vitamin C supplementation in autologous stem cell transplantations
- Conditions
- lymphomamultiple myeloma1002532210018865
- Registration Number
- NL-OMON55772
- Lead Sponsor
- Medisch Universitair Ziekenhuis Maastricht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 47
- 18 years or older
- written informed consent
- diagnosis of malignant lymphoma or multiple myeloma
- require chemotherapy plus autologous stem cell transplantation
- central venous catheter in place or planned
- inability to understand the nature and extent of the trial and the procedures
required
- history of kidney stones
- kidney failure requiring dialysis or eGFR <30 mL/min. (CDK-EPI formula)
- history of G6PD deficiency
- life expectancy < 1 month
- use of immunosuppressive medication other than chemotherapy and
corticosteroids
- active vitamin C supplementation other than normal daily multivitamin use
- any concurrent medical or psychiatric condition or disease that is likely to
interfere with the study procedures or results, or that in the opinion of the
investigator would constitute a hazard for participating in this study.
- Patients that are eligible after transplantation for a follow up in the
out-patient setting and want to use this option.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary endpoints will be AA plasma level on day 14 (run-in phase) and the day<br /><br>of neutrophil recovery after stem cell transplantation (randomized-controlled<br /><br>phase).</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary endpoints will be AA leukocyte levels, infection rate, duration of<br /><br>hospital stay, side effects of chemotherapy, overall survival, coagulation<br /><br>parameters, platelet reactivity, fibrinolysis and quality of life.</p><br>