Hypovitaminosis D is highly prevalent in people with lung cancer, and may have adverse clinical consequences. The long and variable pharmacokinetic half-life of vitamin D makes prompt vitamin D replacement problematic. This is an open, one-armed therapeutic intervention using a loading dose of vitamin D that will be predicted to increase plasma 25-hydroxyvitamin D concentrations of every patient well into the normal range (\> 100 nmol/L) within 2 or 3 weeks and monitored after 2 and 3 weeks of loading and maintenance dose. Preliminary data will also be obtained to identify potentially clinical important outcome benefits for future investigation. The outcomes are 1. plasma 25OHD concentration 2. Vitamin D binding protein and other plasma concentrations 3. Mood and symptom
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
80
vitamin D3 20,000 IU per day for 14 days followed by 10,000 IU per day for a further 7 days
Brojde Lung Cancer Centre, Jewish General Hospital
Montreal, Quebec, Canada
Plasma 25-hydroxyvitamin D concentration
Plasma 25OHD concentration measured within 24 h prior to commencing vitamin D therapy, and again after 14 and 21 days of continuous vitamin D therapy
Time frame: 3 weeks
Mood
Two validated brief mood assessment questionnaires measured 1. On two occasions (one week apart) at baseline prior to staring therapy 2. After 2 weeks of therapy 3. After 3 weeks of therapy
Time frame: 3 weeks
Symptoms
As with mood questionnaire, a symptom questionnaire (Edmonton Symptom Assessment System) will be administered two times (one week apart) prior to starting vitamin therapy and after 14 and 21 days of continuous vitamin D administration
Time frame: 3 weeks
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