Does vitamin D deficiency contribute to fatigue in patients in remission after treatment of gynaecological malignancy.

Annually in approximately 4000 women in the Netherlands a gynaecological
malignancy is diagnosed. Severe fatigue is a huge problem in a great number of
patients who have received treatment because of a gynaecological malignancy.
Studies showed that Quality of life is negatively influenced by severe fatigue.
Patients treated because of a malignancy are at risk for a vitamin D deficiency
due the reduced ability of the older skin to produce vitamin D and decreased
exposition to sunlight because of their illness.
Vitamin D deficiency is associated with a range of complaints, such as fatigue,
muscle weakness and muscular pains, and an increased risk of fractures.
Vitamin D deficiency is easily treated by means of supplementation therapy.
A pilot study of patients treated because of a gynaecological malignancy and
diagnosed with a vitamin D deficiency (who visited the outpatients department
of the Meander Medical Centre), showed a substantial improvement of their
wellbeing after supplementation therapy.

-To answer the main question *Can we demonstrate a decreased prevalence of
fatigue (i.e. a lower score on the fatigue assessment) in patients in complete
remission after successful treatment of a gynaecological malignancy, after
treatment of a vitamin D deficiency with vitamin D supplementation therapy
compared to patients treated with a placebo?*

-To answer the secondary question: *Can we demonstrate a decreased prevalence
of fatigue (i.e. a lower score on the fatigue assessment) in patients in
complete remission after successful treatment of a gynaecological malignancy,
by whom an adequate vitamin D level has been diagnosed, after treatment with
vitamin D supplementation therapy compared to patients treated with a
placebo?*

Prospective double-blind placebo controlled.

Methods:
-Validated questionaire regarding fatigue and symptoms of a vitamin D
deficiency. (t=0 and t= 2 months).
-Blood test to determine the 25-hydroxy vitamine D3 level (t=0 and t= 2 months).
-After randomisation all participating patients will be treated with either
Calcium Vitamin D supplementation (100.000 IE, oral) or a placebo (oil-water
solubilisation).

All participating patients will randomly receive either Calcium Vitamin D
supplementation (100.000 IE, oral) or a placebo (oil-water solubilisation).

1) Possible side effects of vitamin D supplementation therapy: hypersensitivity
is possible, however extremely rare. An overdose of vitamin D (levels >
500nmol/l) may lead to high calcium and phosphate bloodlevels. (due to
increased resorption of calcium and phosphate in the intestines and due to
bone destruction). We may refer to the paragraph on safety of vitamin D
supplementation therapy.
2) Participation in this study, implies twice a bloodtest and twice a
questionnaire. The bloodtest is done in the context of the follow-up treatment
after a gynaecological malignancy; participation in this study does not require
an extra bloodtest.
The questionnaire requires twice some extra time (about 10 minutes) after the
appointment at the outpatients department.
3) The vitamin D level is obtained by a venous bloodtest. This is a minimally
invasive procedure, and performed by the laboratory of the hospital. Possible
side effects might be pain the around the site of needle sting and a small
haematoma is possible.
4) A treatment delay of 2 months is safe for patients with a vitamin D
deficiency. It is also safe to prescribe a single dose of 100.000 IE vitamin D
to patients with an adequate vitamin D level.