Phase 3
N=436
Vitamin D Supplementation in Cutaneous Malignant Melanoma Outcome
Cutaneous Malignant Melanoma
Bottom Line
View on ClinicalTrials.gov: NCT01748448 ↗Enrolled (actual)
436
Serious AEs
14.0%
Results posted
Feb 2025
Primary outcome: Primary: Relapse Free Survival — 41; 32 Participants — p== 0.324
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Vitamin D (Drug); Placebo: Oil (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
- Primary completion
- Jul 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Relapse Free Survival |
41; 32 | = 0.324 |
| SECONDARY Melanoma Subtype, as Assessed Clinically and Histologically |
38; 29; 115; 142; 8; 6 | — |
| SECONDARY Melanoma Site, as Clinically Recorded |
18; 26; 45; 37; 12; 12 | — |
| SECONDARY 25(OH)D3 Serum Levels |
24; 23; 43; 23; 44; 24 | — |
| SECONDARY Stage of Melanoma Patient |
24; 26; 101; 108; 29; 30 | — |
Summary
To assess whether vitamin D supplementation after surgery of a first cutaneous malignant melanoma protects against relapse of the disease.
Eligibility Criteria
Inclusion Criteria
- Older than 18 years and younger than 80 years of age.
- Histologically proven malignant melanoma, stage one B (IB) to three (III) Not participating in other clinical trial.
- The only treatment for melanoma is surgical treatment.
- Complete resection of melanoma.
- Single primary invasive cutaneous melanoma
- Signed ethical committee approved informed consent
- Serum phosphate, serum calcium at the entry of the study within normal limits of laboratory reference
Exclusion criteria
- Pregnant/lactating women or planning on becoming pregnant during the study
- Known hypersensitivity to vitamin D or its components.
- Pre-existing renal stone disease, chronic renal disease with glomerular filtration rate (eGFR) 2 fold upper limit of normal (ULN).
- History of parathyroid disease or granulomatous disease (TBC and sarcoidosis)
- History of malabsorption syndrome or any medical condition that might interfere with vitamin D absorption.
- History of small intestine resection.
- 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.
- Chronic alcohol abuse.
- Medical or logistic problems likely to preclude completion of the study.
- 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)
- Intake of vitamin D supplements within 6 months prior to entry of the study.
Data sourced from ClinicalTrials.gov (NCT01748448). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.