Vitamin D Loading Dose in Advanced Lung Cancer

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

Study Overview

• Status: Completed
• Conditions: Lung Cancer
• Intervention / Treatment: Dietary supplement: vitamin D

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H3T 1E2
      • Brojde Lung Cancer Centre, Jewish General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	3 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	3 weeks
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	3 weeks

Collaborators and Investigators

• Sponsor: Jewish General Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): February 1, 2016

Study Registration Dates

• First Submitted: June 27, 2012
• First Submitted That Met QC Criteria: June 27, 2012
• First Posted (Estimate): June 29, 2012

Study Record Updates

• Last Update Posted (Actual): August 18, 2017
• Last Update Submitted That Met QC Criteria: August 15, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: pharmacokinetics; Lung cancer; vitamin D
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Vitamin D
• Other Study ID Numbers: REC12-053

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No