NCT01631526

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Jewish General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Lung Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2012-06-01
• Primary completion: 2015-11-01
• Completion: 2016-02-01
• First posted: 2012-06-29
• Last updated: 2017-08-18

Locations

1 site across 1 country: Canada