Vitamin D deficiency in patients in complete remission after successful treatment of a gynaecological malignancy.
Conditions
Interventions
Trade Name: Vit D AQ 50.000 IU/ml FNA 5ml
Product Name: Colecalciferol
Pharmaceutical Form: Gastroenteral solution
Pharmaceutical form of the placebo: Gastroenteral solution
Route of administration of
Sponsors
Meander Medisch Centrum
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients in remission after succesful treatment of ovary carcinoma, endometrial carcinoma, cervical carcinoma, tubal carcinoma or vulva carcinoma. Remission is defined as a disease free status of at least 6 months after termination of the treatment. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: -Patients with relapsing disease after initial succesful treatment of a gynaecological malignancy. -Patients with relapsing disease during the study period or within 3 months after inclusion after initial succesful treatment of a gynaecological malignancy. -Patients with renal failure; by definition a MDRD < 60 ml/min, because of the reduced effectiveness of 25(OH)vitamine D.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To study the prevalence of a vitamin D deficiency and the prevalence of fatigue in patients in complete remission after successful treatment of a gynaecological malignancy. ;Primary end point(s): Vitamin D level and fatigue score at t=0 months and t=3 months. ;Secondary Objective: -To answer the question "Is fatigue and weakness, in patients in complete remission after successful treatment of a gynaecological malignancy, a consequence of the disease and/ or the treatment and/ or is a vitamine D deficiency of major importance as well? -To test the hypothesis "A decreased score on the fatigue assessment is found in patients in complete remission after successful treatment of a gynaecological malignancy, after treatment of a vitamin D deficiency with vitamin D supplementation therapy in comparison with patients treated with a placebo.” | — |
Countries
Netherlands
Outcome results
None listed