Efficacy of vitamin D supplementation in multiple myeloma patients.

Phase 1

• Conditions: Hypovitaminosis D; Therapeutic area: Body processes [G] - Cell Physiological Phenomena [G04]

• Registration Number: EUCTR2017-005110-58-NL
• Lead Sponsor: Medical Centre Leeuwarden

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-05-14
• Last Update Posted: 25 June 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Subjects 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 11
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 29

Exclusion Criteria

Contraindications 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.
The use of vitamin D tablets or multivitamin tablets containing vitamin D

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified