Vitamin D Loading Dose in Advanced Lung Cancer

NCT01631526 | Completed

• 1 other identifier: REC12-053
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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. 1.plasma 25OHD concentration
2. 2.Vitamin D binding protein and other plasma concentrations
3. 3.Mood and symptom

Conditions

Lung Cancer

Keywords

Lung cancer; vitamin D; pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Mood

  3 weeks

• Symptoms

  3 weeks

Study Arms (1)

Vitamin D

EXPERIMENTAL

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

Interventions

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

Vitamin D

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jewish General Hospital: lead

Study Sites (1)

Brojde Lung Cancer Centre, Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

Related Publications (1)

• 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.

  PMID: 27716304 DERIVED

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine, McGill University

Study Record Dates

• First Submitted: June 27, 2012
• First Posted: June 29, 2012
• Study Start: June 1, 2012
• Primary Completion: November 1, 2015
• Study Completion: February 1, 2016
• Last Updated: August 18, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)