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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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Lung Cancer

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Plasma 25-hydroxyvitamin D concentration

Outcome 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

Outcome Time Frame:

3 weeks

Safety Issue:

No

Authority:

Canada: Ethics Review Committee

Study ID:

REC12-053

NCT ID:

NCT01631526

Start Date:

June 2012

Completion Date:

December 2013

Related Keywords:

  • Lung Cancer
  • Lung cancer
  • vitamin D
  • pharmacokinetics
  • Lung Neoplasms

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