Vitamin D Supplementation in Cutaneous Malignant Melanoma Outcome

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

436 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2022-07-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Cutaneous Malignant Melanoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Vitamin D

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

Group Type ACTIVE_COMPARATOR

Vitamin D

Intervention Type DRUG

* prospective interventional randomized double blind placebo controlled trail
* clinical setting (tertiary university hospital)
* investigator driven, no pharmaceutical sponsor
* cutaneous malignant melanoma patients
* add- on study (placebo or vitamin D) on top of optimal standard care
* 1:1 inclusion ratio (placebo:Vitamin D)
* randomisation after informed consent and screening

Placebo: Oil

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

Group Type PLACEBO_COMPARATOR

Placebo: Oil

Intervention Type DRUG

Interventions

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Vitamin D

* prospective interventional randomized double blind placebo controlled trail
* clinical setting (tertiary university hospital)
* investigator driven, no pharmaceutical sponsor
* cutaneous malignant melanoma patients
* add- on study (placebo or vitamin D) on top of optimal standard care
* 1:1 inclusion ratio (placebo:Vitamin D)
* randomisation after informed consent and screening

Intervention Type DRUG

Placebo: Oil

Intervention Type DRUG

Other Intervention Names

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D-Cure Cholecalciferol Placebo

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No