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Efficacy of vitamin D supplementation in deficient multiple myeloma patients


- candidate number28251
- NTR NumberNTR6848
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR22-nov-2017
- Secondary IDs64024 ABR-nummer
- Public TitleEfficacy of vitamin D supplementation in deficient multiple myeloma patients
- Scientific TitleEfficacy of a predefined vitamin D dosing regimen in vitamin D-deficient multiple myeloma patients
- ACRONYMmultiple myeloma, vitamin D, peripheral neuropathy
- hypothesisSupplementation of vitamin D in vitamin D-deficient multiple myeloma patients following a predifined vitamin D dosing regimen will result in adequate vitamin D levels in these patients
- Healt Condition(s) or Problem(s) studiedMultiple Myeloma (MM), Periferal neuropathy, Hypovitaminosis D
- Inclusion criteriaSubjects are (newly) diagnosed with smoldering or symptomatic multiple myeloma
Subjects must be over 18 years of age
Subjects must be able to give informed consent
Subjects with a 25-hydroxyvitamin D level <75 nmol/l
- Exclusion criteriaContraindications for the use of vitamin D:
- Hypersensitivity to the active substance(s) or to any of the excipients
- Hypercalcaemia and/or hypercalciuria
- Nephrolithiasis and/or nephrocalcinosis
- Serious renal impairment
- Hypervitaminosis D
- Pseudohypoparathyroidism
- mec approval receivedno
- multicenter trialyes
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeobservational
- planned startdate 10-dec-2017
- planned closingdate10-dec-2018
- Target number of participants100
- InterventionsPatients receive vitamin D-supplements for six months and will receive a vitamin D loading dose (may be repeated after two months). In addition, every patient will complete the ICPNQ Questionnaire and VAS scores after 2 and 6 months to determine neuropathy grading. After 2 (, possibly 3) and 6 months blood samples will be taken.
- Primary outcomeThe efficacy of a predefined vitamin D dosing regimen in obtaining an adequate serum 25-hydroxyvitamin D level in multiple myeloma patients. The main endpoint is the difference in vitamin D levels at the beginning and end of the study.
- Secondary outcomeSecondary study parameters are:
- to determine the efficacy of vitamin D supplementation on the prevalence and severity of peripheral neuropathy in multiple myeloma patients;
- to determine differences between the effect of vitamin D supplementation on the prevalence and severity of PN for patients with or without MM treatment
- to determine differences between the effect of vitamin D supplementation on the prevalence and severity of PN for each individual drug used for MM. Drugs that can be used: bortezomib, carfilzomib, daratumumab, elotuzumab, ixazomib, lenalidomide, panobinostat, pomalidomide, thalidomide and vincristine
- to detect the influence of several variables (age, gender, cumulative dose, type of treatment, race, the use of alcohol, and the presence of diabetes mellitus) on the chance of successfully increasing the vitamin D serum concentration.
- TimepointsAt the start of the study patients will get an intake in which a vitamin D loading dose (200.000 IE) will be given. In addition, patients start with 800IE of vitamin D once daily. After 2 months, blood samples will be taken and the ICPNQ questionnaire and VAS scores will be completed. If vitamin D levels are below 75 nmol/L, another loading dose will be given and vitamin D doses will be increased to 1600IE. The vitamin D levels of these patients will be measured again after three months. If vitamin D levels are still below 75 nmol/L, vitamin D doses will be increased again to 3200 IE. After six months, vitamin D will be measured and the ICPNQ Questionnaire and VAS scores will be completed.
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES Berdien Oortgiesen
- CONTACT for SCIENTIFIC QUERIES Berdien Oortgiesen
- Sponsor/Initiator Medical Centre Leeuwarden, Department of Clinical Pharmacy and Pharmacology
- Funding
(Source(s) of Monetary or Material Support)
Wetenschapsfonds MCL, Leeuwarden, The Netherlands
- Publications
- Brief summaryRandomized controlled studies have shown that the introduction of the 'new agents' bortezomib, thalidomide and lenalidomide resulted in improved response, progression-free survival and overall survival. However, vitamin D-deficiency is a frequent problem for patients with multiple myeloma. In addition, there is a high prevalence of peripheral neuropathy among these patients. Several studies have shown that an adequate vitamin D level has several advantages for the human body, such as improvement of the muscle function and the immune system. Obtaining an adequate vitamin D level in patients with multiple myeloma is therefore a major gain in which the quality of life can improve or decrease less quickly. Vitamin D-deficiency is also associated with many complications, such as a decrease in bone density and possibly peripheral neuropathy.
Vitamin D could potentially be used to prevent peripheral neuropathy in patients with multiple myeloma.
- Main changes (audit trail)
- RECORD22-nov-2017 - 12-dec-2017


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