Vitamin D supplementation in cutaneous malignant melanoma outcome - Vitamin D and cutaneous malignant melanoma outcome

ZLeuven0 sites500 target enrollmentAugust 21, 2012

Overview

No summary available.

Registry

who.int

Start Date

August 21, 2012

End Date

TBD

Last Updated

8 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

ZLeuven

•1\.Older than 18 years and younger than 80 years of age.
•2\.Histologically proven malignant melanoma, stage IB to III Not participating in other clinical trial.
•3\.The only treatment for melanoma is surgical treatment.
•4\.Complete resection of melanoma.
•5\.Single primary invasive cutaneous melanoma (inclusion within 1 year after diagnosis).
•6\.Signed ethical committee approved informed consent
•7\.Serum phosphate and calcium at the entry of the study within normal range of the laboratory reference
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes

•1\.Pregnant/lactating women or planning on becoming pregnant during the study
•2\.Known hypersensitivity to vitamin D or its components.
•3\.Pre\-existing renal stone disease or chronic renal disease with eGRF \< 30 mL/min/1\.73 m2 or renal dialysis.
•4\.Liver failure or chronic liver disease with liver enzyme \> 2 fold ULN (\=upper limit of normal)
•5\.History of parathyroid disease or granulomatous disease (TBC and sarcoidosis)
•6\.History of malabsorption syndrome or any medical condition that might interfere with vitamin D absorption.
•7\.History of other malignancy within the last 5 years except for carcinoma in situ of the cervix or basal cell carcinoma or squamous cell carcinoma of the skin or in situ malignant melanoma.
•8\.Chronic alcohol abuse.
•9\.Medical or logistic problems likely to preclude completion of the study.