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Vitamin D Supplementation in Cutaneous Malignant Melanoma Outcome

Phase 3
18 Years
80 Years
Open (Enrolling)
Cutaneous Malignant Melanoma

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Trial Information

Vitamin D Supplementation in Cutaneous Malignant Melanoma Outcome

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.

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 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.

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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Relapse free survival

Outcome Description:

Disease free survival will be the primary endpoint of this phase III trial. Patients are enrolled during a recruitment phase of three years maximum. Study duration for one patient is maximum 3,5 years or until relapse occurs.

Outcome Time Frame:

study duration maximum 3,5 years

Safety Issue:


Principal Investigator

Marjan Garmyn, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Universitaire Ziekenhuizen Leuven


Belgium: Federal Agency for Medicinal Products and Health Products

Study ID:




Start Date:

December 2012

Completion Date:

December 2016

Related Keywords:

  • Cutaneous Malignant Melanoma
  • Cutaneous malignant melanoma
  • Vitamin D
  • Cholecalciferol
  • Melanoma
  • Skin Neoplasms