Vitamin D Loading Dose in Advanced Lung Cancer

Study Overview
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Brief Summary
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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 plasma 25OHD concentration Vitamin D binding protein and other plasma concentrations Mood and symptom

Official Title
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Open Clinical Trial to Validate a Short-term Vitamin D Loading and Maintenance Dose Protocol in People With Advanced Lung Cancer

Conditions
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Lung Cancer

Intervention / Treatment
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* Dietary Supplement: vitamin D


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Any patient with advanced lung cancer whether or not receiving specific anti-cancer therapy Mentally competent (but need not be fluent in French or English if capable neutral translator available) Self report of reduced food intake and/or involuntary weight loss of any extent at time of enrollment: does not have to be documented Exclusion Criteria: Current diagnosis of primary hyperparathyroidism Nephrocalcinosis Current or suspected active tuberculosis, histoplasmosis, sarcoidosis, or other granulomatous disease Current using a vitamin D supplement providing > 1000 IU/day Current prescribed calcitriol in any dose History of extensive sunlight exposure (> 30 min summer sunlight exposure per day for more than 5 days per week) in previous 3 months Expected to die within next 2 months Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vitamin D<br>vitamin D 20,000 IU per day for 2 weeks followed by 10,000 IU per day for a further 7 days | Dietary Supplement: vitamin D<br>* vitamin D3 20,000 IU per day for 14 days followed by 10,000 IU per day for a further 7 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mood | Two validated brief mood assessment questionnaires measured On two occasions (one week apart) at baseline prior to staring therapy After 2 weeks of therapy After 3 weeks of therapy | 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 | 3 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lung cancer, vitamin D, pharmacokinetics