Cholecalciferol
| Evidence Level: L5 | Predicted Indications: 7 |
Table of Contents
- Cholecalciferol
- Cholecalciferol: From Vitamin D Nutritional Supplementation to Familial Isolated Hypoparathyroidism
Cholecalciferol: From Vitamin D Nutritional Supplementation to Familial Isolated Hypoparathyroidism
One-Sentence Summary
Cholecalciferol (vitamin D3) is a nutritional vitamin D. In South Africa it is registered only as a component of the Cernevit infusion. The TxGNN model predicts it may be useful for familial isolated hypoparathyroidism due to impaired PTH secretion, but there are currently 0 clinical trials and 0 publications specific to this disease. This is a model prediction only.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not stated in the supplied SAHPRA record (the approved indication text is empty); the title reflects cholecalciferol’s general role as a nutritional vitamin D |
| Predicted New Indication | Familial isolated hypoparathyroidism due to impaired PTH secretion |
| TxGNN Prediction Score | 99.79% |
| Evidence Level | L5 |
| South Africa Market Status | Marketed |
| Number of SAHPRA Registrations | 1 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data is not available. Vitamin D metabolism is closely tied to parathyroid hormone (PTH) and calcium balance, which is probably why the model links the two.
There is a caveat. In hypoparathyroidism the usual treatment is active vitamin D (calcitriol or alfacalcidol), not nutritional cholecalciferol. The reason is that the kidney step that activates vitamin D (1-alpha-hydroxylation) depends on PTH and is impaired when PTH secretion fails. Plain cholecalciferol is therefore not expected to replace active vitamin D. The high score most likely reflects biological proximity in the knowledge graph, not evidence of benefit.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
Currently no related literature available.
South Africa Market Information
| Registration Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| Reg. No. 36/22.1/0508 | Cernevit | Infusion | Not stated in the supplied record |
Only an injectable (infusion) product is registered. No oral cholecalciferol registration appears in the supplied data, and Essential Medicines List status is not provided.
Safety Considerations
Please refer to the SAHPRA-approved Professional Information (PI) for safety information. Report adverse drug reactions to SAHPRA.
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction has no trials and no literature behind it. Current practice also uses active vitamin D rather than nutritional cholecalciferol in this condition. The only registered South African product is an infusion, and its safety information has not been retrieved.
To proceed, the following is needed:
- SAHPRA Professional Information (warnings, contraindications) for Cernevit, which is currently blocking safety screening
- Mechanism of action data from DrugBank
- A targeted literature and trial search on cholecalciferol versus active vitamin D in hypoparathyroidism
- A route-compatibility check, because only an infusion is registered
Other predictions for this drug: Hypophosphatemic rickets, renal osteodystrophy and renal tubular acidosis have more supporting material and are graded L4 as research questions. In each case the evidence is indirect, and no trial has been confirmed to test cholecalciferol itself. If this drug is pursued, those indications are better places to start.
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.