Vitamin D Loading Dose in Advanced Lung Cancer
Primary Purpose
Lung Cancer
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
vitamin D
Sponsored by
About this trial
This is an interventional treatment trial for Lung Cancer focused on measuring Lung cancer, vitamin D, pharmacokinetics
Eligibility Criteria
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
Sites / Locations
- Brojde Lung Cancer Centre, Jewish General Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Vitamin D
Arm Description
vitamin D 20,000 IU per day for 2 weeks followed by 10,000 IU per day for a further 7 days
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01631526
Brief Title
Vitamin D Loading Dose in Advanced Lung Cancer
Official Title
Open Clinical Trial to Validate a Short-term Vitamin D Loading and Maintenance Dose Protocol in People With Advanced Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
February 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jewish General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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
plasma 25OHD concentration
Vitamin D binding protein and other plasma concentrations
Mood and symptom
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
Lung cancer, vitamin D, pharmacokinetics
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vitamin D
Arm Type
Experimental
Arm Description
vitamin D 20,000 IU per day for 2 weeks followed by 10,000 IU per day for a further 7 days
Intervention Type
Dietary Supplement
Intervention Name(s)
vitamin D
Intervention Description
vitamin D3 20,000 IU per day for 14 days followed by 10,000 IU per day for a further 7 days
Primary Outcome Measure Information:
Title
Plasma 25-hydroxyvitamin D concentration
Description
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
Secondary Outcome Measure Information:
Title
Mood
Description
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
Time Frame
3 weeks
Title
Symptoms
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Brojde Lung Cancer Centre, Jewish General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
27716304
Citation
Hoffer LJ, Robitaille L, Swinton N, Agulnik J, Cohen V, Small D, Pepe C, Eintracht S. Appropriate vitamin D loading regimen for patients with advanced lung cancer. Nutr J. 2016 Oct 6;15(1):84. doi: 10.1186/s12937-016-0203-8.
Results Reference
derived
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Vitamin D Loading Dose in Advanced Lung Cancer
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