Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| vitamin D | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Vitamin D
- description
- vitamin D 20,000 IU per day for 2 weeks followed by 10,000 IU per day for a further 7 days
- interventionNames
- Dietary Supplement: vitamin D
Primary outcomes (1)
- measure
- Plasma 25-hydroxyvitamin D concentration
- timeFrame
- 3 weeks
- description
- 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
Secondary outcomes (2)
- measure
- Mood
- timeFrame
- 3 weeks
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDHoffer 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