Vitamin D Loading Dose in Advanced Lung Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2016-02-29

Brief Summary

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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

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Detailed Description

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Conditions

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Lung Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Vitamin D

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

Group Type EXPERIMENTAL

vitamin D

Intervention Type DIETARY_SUPPLEMENT

vitamin D3 20,000 IU per day for 14 days followed by 10,000 IU per day for a further 7 days

Interventions

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vitamin D

vitamin D3 20,000 IU per day for 14 days followed by 10,000 IU per day for a further 7 days

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No