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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Mood | Two validated brief mood assessment questionnaires measured
| 3 weeks |
| Symptoms |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brojde Lung Cancer Centre, Jewish General Hospital | Montreal | Quebec | H3T 1E2 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27716304 | Derived | 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. |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D014807 | Vitamin D |
| ID | Term |
|---|---|
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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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 |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |