Calcitriol
| Evidence Level: L5 | Predicted Indications: 5 |
Table of Contents
- Calcitriol
- Pharmacist Assessment Report
- Calcitriol: active form of vitamin D (hormonal vitamin D metabolite) → obsolete vitamin D deficiency
- One-Sentence Summary
- Quick Overview
- Why is This Prediction Reasonable?
- Clinical Trial Evidence
- Literature Evidence
- Australia Market Information
- Safety Considerations
- Conclusion and Next Steps
- Disclaimer
Calcitriol: active form of vitamin D (hormonal vitamin D metabolite) → obsolete vitamin D deficiency
One-Sentence Summary
Calcitriol is the active hormonal form of vitamin D and is marketed in Australia as an oral capsule. The TxGNN model predicts it may be relevant to obsolete vitamin D deficiency (a disease term flagged as obsolete in the ontology). No clinical trials and no publications were found for this prediction, so it rests on the model score alone.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not recorded in the local data |
| Predicted New Indication | obsolete vitamin D deficiency |
| TxGNN Prediction Score | 0.9996 |
| Evidence Level | L5 |
| Australia Market Status | Listed on the PBS Schedule (1 of 1 items) – TGA (ARTG) registration status is not included in this data |
| Number of PBS Items | 1 (valid: 1) |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Detailed mechanism of action data is not available in the data compiled for this report. Calcitriol is the active form of vitamin D, so a mechanistic link to vitamin D deficiency is biologically plausible.
There are important caveats. The disease term is flagged as obsolete in the ontology, so it may not map cleanly onto a current clinical diagnosis. Nutritional vitamin D deficiency is usually treated with cholecalciferol or ergocalciferol rather than calcitriol, which is the already-activated hormone. The high TxGNN score is a model prediction only and is not supported by trial or literature evidence.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
Currently no related literature available.
Australia Market Information
| ARTG Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| ARTG 13457G | Rocaltrol | Capsule 0.25 microgram (oral) | Not recorded in the local data |
Safety Considerations
- Drug Interactions (100 interactions recorded in total; main examples):
- Major: cholecalciferol, calcifediol, burosumab. Co-administration with other vitamin D products or analogues risks additive effects, including hypercalcaemia.
- Moderate:
- Thiazide diuretics (hydrochlorothiazide, bendroflumethiazide, chlorothiazide, chlorthalidone, benzthiazide)
- Enzyme-inducing anticonvulsants and barbiturates (carbamazepine, fosphenytoin, amobarbital, butabarbital, butalbital)
- Bile acid sequestrants (cholestyramine, colesevelam, colestipol)
- Digoxin and digitoxin
- Aluminium hydroxide
- Topical calcipotriol
Please refer to the TGA-approved Product Information (PI) for warnings and contraindications, as these were not available in the data compiled for this report.
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction has a high model score but no supporting clinical trials or publications. The disease term is obsolete, and standard care for nutritional vitamin D deficiency uses other vitamin D forms. The evidence level is L5.
To proceed, the following is needed:
- Clarification of which current clinical diagnosis the obsolete disease term corresponds to
- Evidence from trials or studies that directly address this condition with calcitriol
- Mechanism of action data and TGA Product Information warnings and contraindications
- A comparison against standard vitamin D supplementation (cholecalciferol or ergocalciferol), including a hypercalcaemia monitoring plan
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.