Vitamin D Loading Dose in Advanced Lung Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2015 by Jewish General Hospital
Information provided by (Responsible Party):
John Hoffer, Jewish General Hospital Identifier:
First received: June 27, 2012
Last updated: August 31, 2015
Last verified: August 2015

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

Condition Intervention Phase
Lung Cancer
Dietary Supplement: vitamin D
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open Clinical Trial to Validate a Short-term Vitamin D Loading and Maintenance Dose Protocol in People With Advanced Lung Cancer

Resource links provided by NLM:

Further study details as provided by Jewish General Hospital:

Primary Outcome Measures:
  • Plasma 25-hydroxyvitamin D concentration [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

    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

  • Symptoms [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
    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

Estimated Enrollment: 80
Study Start Date: June 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vitamin D
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
vitamin D3 20,000 IU per day for 14 days followed by 10,000 IU per day for a further 7 days


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01631526

Contact: Leonard John Hoffer, MD PhD 514 340 8222 ext 5276

Canada, Quebec
Brojde Lung Cancer Centre, Jewish General Hospital Recruiting
Montreal, Quebec, Canada, H3T 1E2
Principal Investigator: Leonard John Hoffer, MD PhD         
Sponsors and Collaborators
Jewish General Hospital
  More Information

No publications provided

Responsible Party: John Hoffer, Professor of Medicine, McGill University, Jewish General Hospital Identifier: NCT01631526     History of Changes
Other Study ID Numbers: REC12-053
Study First Received: June 27, 2012
Last Updated: August 31, 2015
Health Authority: Canada: Ethics Review Committee

Keywords provided by Jewish General Hospital:
Lung cancer
vitamin D

Additional relevant MeSH terms:
Lung Neoplasms
Lung Diseases
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Vitamin D
Bone Density Conservation Agents
Growth Substances
Pharmacologic Actions
Physiological Effects of Drugs processed this record on October 08, 2015