Vitamin D Loading Dose in Advanced Lung Cancer
Conditions
Lung Cancer
Conditions: official terms
Lung Neoplasms
Conditions: Keywords
Lung cancer, vitamin D, pharmacokinetics
Study Type
Interventional
Study Phase
Phase 1
Study Design
Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: vitamin D
Type: Dietary Supplement
Overall Status
Recruiting
Summary
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. Mood

3. Symptoms
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

1. Any patient with advanced lung cancer whether or not receiving specific anti-cancer therapy

2. Mentally competent (but need not be fluent in French or English if capable neutral translator available)

3. 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:

1. Current diagnosis of primary hyperparathyroidism

2. Nephrocalcinosis

3. Current or suspected active tuberculosis, histoplasmosis, sarcoidosis, or other granulomatous disease

4. Current using a vitamin D supplement providing > 1000 IU/day

5. Current prescribed calcitriol in any dose

6. History of extensive sunlight exposure (> 30 min summer sunlight exposure per day for more than 5 days per week) in previous 3 months

7. Expected to die within next 2 months

8. Pregnancy
Location
Brojde Lung Cancer Centre, Jewish General Hospital
Montreal, Quebec, Canada
Status: Recruiting
Start Date
June 2012
Completion Date
December 2013
Sponsors
Jewish General Hospital
Source
Jewish General Hospital
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page