The purpose of this study is to compare normalization of vitamin D serum level after 6 months of vitamin D supplementation adjusted to baseline vitamin D serum level vs.conventional vitamin D supplementation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
215
Tablet to suck: calcium 500 mg bid, cholecalciferol 200 IU bid
Tablet: calcium 500 mg bid + 2 ml drinkable solution cholecalciferol 100 000 IU whose schedule of administration depends on vitamin deficiency level: * 100 000 IU of vitamin D3 at D1, D15, D28 and D43 if 25-OHD level \< 10 ng/mL * 100 000 IU of vitamin D3 at D1, D15, D28 if 10 ng/mL ≤ 25-OHD level \< 20 ng/mL * 100 000 IU of vitamin D3 at D1 if 20 ng/mL ≤ 25-OHD level \< 30 ng/mL
CRLC Val d'Aurelle-Paul Lamarque
Montpellier, France
To evaluate the increase in normalization of serum vitamin D level
To compare the increase in normalization of serum vitamin D level adjusted to baseline level in patients receiving either vitamin D supplementation tailored to vitamin D deficiency or conventional vitamin D supplementation.
Time frame: 6 months
Baseline vitamin D/calcium status in this patient population
Time frame: Baseline
Normalization rate of serum 25-OHD level
Time frame: 12, 18 and 24 months
Normalization rate of serum 25-OHD level in control patients who shift to experimental strategy
Time frame: 6 months after crossover
Clinical and biological tolerance profile
According to National Cancer Institute-Common Terminology Criteria for Adverse Events Version 4.0
Time frame: During treament administration (can last up to 24 months)
Treatment compliance
Treatment compliance will be assessed using a patient record book
Time frame: During treatment administration (can last up to 24 months)
Quality of life
Quality of life is assessed using the EORTC QLQ-C30 questionnaire
Time frame: 24 months
Impact of study treatments on bone and joint pains induced by aromatase inhibitors
Time frame: During treatment administration (can last up to 24 months)
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Changes in vitamin and calcium biological markers
Time frame: Up to 24 months
Predictive value of individual biomarkers
Time frame: Up to 24 months