Vitamin D Loading Dose in Advanced Lung Cancer

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01631526
• Other study ID #: REC12-053
• Status: Completed
• Phase: N/A
• First received: June 27, 2012
• Last updated: August 15, 2017
• Start date: June 2012
• Est. completion date: February 2016

Study information

• Verified date: August 2017
• Source: Jewish General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: February 2016
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

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

Locations

Country	Name	City	State
Canada	Brojde Lung Cancer Centre, Jewish General Hospital	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Jewish General Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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