Vitamin D Loading Dose in Advanced Lung Cancer

Not Applicable

Completed

• Conditions: Lung Cancer
• Interventions: Dietary Supplement: vitamin D

• Registration Number: NCT01631526
• Lead Sponsor: Jewish General Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-06-27
• Study First Submitted QC: 2012-06-27
• Study First Posted: 2012-06-29
• Primary Completion: 2015-11
• Study Completion: 2016-02
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-15
• Last Update Posted: 2017-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Vitamin D	vitamin D	vitamin D 20,000 IU per day for 2 weeks followed by 10,000 IU per day for a further 7 days

Primary Outcome Measures

Name	Time	Method
Plasma 25-hydroxyvitamin D concentration	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 Outcome Measures

Name	Time	Method
Mood	3 weeks	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	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

Trial Locations

Locations (1)

Brojde Lung Cancer Centre, Jewish General Hospital; 🇨🇦 Montreal, Quebec, Canada