Vitamin D Supplementation in Cutaneous Malignant Melanoma Outcome (ViDMe)

Universitaire Ziekenhuizen KU Leuven

Status and phase: Completed; Phase 3

Conditions: Cutaneous Malignant Melanoma

Treatments: Drug: Placebo: Oil; Drug: Vitamin D

Study type: Interventional

Funder types: Other

Identifiers

NCT01748448

2012-002125-30 (EudraCT Number)

2012LRDVDCM

Details and patient eligibility

About

To assess whether vitamin D supplementation after surgery of a first cutaneous malignant melanoma protects against relapse of the disease.

Full description

To assess whether vitamin D supplementation, in the follow up period after diagnosis and surgery of a first cutaneous malignant melanoma, has a protective effect on relapse of cutaneous malignant melanoma and whether this protective effect correlates with vitamin D levels in serum and vitamin D receptor (VDR) immunoreactivity in the primary tumor.

Enrollment: 436 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

1. Older than 18 years and younger than 80 years of age.
2. Histologically proven malignant melanoma, stage one B (IB) to three (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
6. Signed ethical committee approved informed consent
7. Serum phosphate, serum calcium at the entry of the study within normal limits of laboratory reference

Exclusion criteria

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, chronic renal disease with glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2 or renal dialysis.
4. Liver failure or chronic liver disease with liver enzymes > 2 fold upper limit of normal (ULN).
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 small intestine resection.
8. 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.
9. Chronic alcohol abuse.
10. Medical or logistic problems likely to preclude completion of the study.
11. Taking medication that predisposes to hypercalcemia (digoxin, lithium, thiazide diuretics) or taking medication that would affect metabolism of vitamin D (anticonvulsants, corticosteroids, H2-receptor antagonists)
12. Intake of vitamin D supplements within 6 months prior to entry of the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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436 participants in 2 patient groups, including a placebo group

Vitamin D

Active Comparator group

Description:

Every month 100 000 units of Vitamin D in syringe oral dispenser is taken . Study duration is maximum 3,5 years or until relapse occurs

Treatment:

Drug: Vitamin D

Placebo: Oil

Placebo Comparator group

Description:

Every month 100 000 units of vitamin D in syringe Oral dispenser is taken. Study duration is maximum of 3.5 years or until relapse occurs

Treatment:

Drug: Placebo: Oil