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Completed

NCT Number: NCT01631526

Vitamin D Loading Dose in Advanced Lung Cancer

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. Vitamin D binding protein and other plasma concentrations 3. Mood and symptom

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Key information

Conditions

Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brojde Lung Cancer Centre, Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin D

Dietary Supplement

vitamin D3 20,000 IU per day for 14 days followed by 10,000 IU per day for a further 7 days

Primary outcomes

  1. Plasma 25-hydroxyvitamin D concentration

    Time frame: 3 weeks

    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 outcomes

  1. Mood

    Time frame: 3 weeks

    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

  2. Symptoms

    Time frame: 3 weeks

    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

Sponsors and collaborators

Lead sponsor

Jewish General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2015
Study completion
2016
First posted
Jun 29, 2012
Registry last updated
Aug 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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