Vitamin D Loading Dose in Advanced Lung Cancer

This study is currently recruiting participants.
Verified June 2013 by Jewish General Hospital
Sponsor:
Information provided by (Responsible Party):
John Hoffer, Jewish General Hospital
ClinicalTrials.gov Identifier:
NCT01631526
First received: June 27, 2012
Last updated: June 20, 2013
Last verified: June 2013
  Purpose

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 2013
Estimated Primary Completion Date: September 2013 (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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01631526

Contacts
Contact: Leonard John Hoffer, MD PhD 514 340 8222 ext 5276 l.hoffer@mcgill.ca

Locations
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
ClinicalTrials.gov Identifier: NCT01631526     History of Changes
Other Study ID Numbers: REC12-053
Study First Received: June 27, 2012
Last Updated: June 20, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by Jewish General Hospital:
Lung cancer
vitamin D
pharmacokinetics

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Vitamin D
Ergocalciferols
Vitamins
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on April 17, 2014