Does vitamin D deficiency contribute to fatigue in patients in remission after treatment of gynaecological malignancy? - VItamine D Influence on FATigue In gynaecological MAlignancy (VIDIFATIMA- trial)
- Conditions
- Vitamin D deficiency in patients in complete remission after successful treatment of a gynaecological malignancy.
- Registration Number
- EUCTR2009-012300-69-NL
- Lead Sponsor
- Meander Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Female
- Target Recruitment
- Not specified
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
-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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.<br><br><br>;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?<br>-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.”
- Secondary Outcome Measures
Name Time Method