Vitamin D Supplementation in Cutaneous Malignant Melanoma Outcome

• Status: Recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Universitaire Ziekenhuizen Leuven
• Collaborators: Katholieke Universiteit Leuven; KU Leuven
• Treatments: Cholecalciferol; Ergocalciferols; Vitamin D; Vitamins

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.