Calcifediol
| Evidence Level: L5 | Predicted Indications: 4 |
Table of Contents
Calcifediol: From an Unrecorded Original Indication to Vitamin D Deficiency
One-Sentence Summary
Calcifediol (25-hydroxyvitamin D) is the main circulating vitamin D metabolite. It is registered in South Africa in oral capsule products, but the record does not state an approved indication. The TxGNN model predicts it may be effective for “obsolete vitamin D deficiency”, an outdated ontology term. This prediction has 0 clinical trials and 0 publications behind it, so it is a model output only.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not recorded in the SAHPRA licence data |
| Predicted New Indication | Obsolete vitamin D deficiency (outdated ontology term) |
| TxGNN Prediction Score | 99.99% |
| Evidence Level | L5 |
| South Africa Market Status | Marketed |
| Number of SAHPRA Registrations | 3 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Detailed mechanism of action data is not currently available. Calcifediol is 25-hydroxyvitamin D, the circulating form of vitamin D that the body measures to judge vitamin D status. It is the intermediate produced by liver hydroxylation of vitamin D and is later converted to active calcitriol in the kidney. On that basis, a link to vitamin D deficiency is biologically plausible.
However, the predicted disease name is an obsolete ontology term, and no trials or publications are attached to it. The score of 99.99% reflects how the model ranks drug-disease links. It is not clinical evidence. The entry should be mapped to a current vitamin D deficiency concept, and evidence re-collected, before any real assessment.
Other predictions for calcifediol have more literature but still no direct trials:
- Vitamin D-dependent rickets (L4): the most promising rationale applies only to type 1B (25-hydroxylase deficiency), where calcifediol directly bypasses the missing enzyme step. The two registered trials are non-phased and address general vitamin D insufficiency or magnesium-related vitamin D resistance, not this disease.
- Hereditary hypophosphatemic rickets (L4) and renal tubular acidosis (L4): the evidence is indirect (physiology studies, animal models, old case reports). Calcifediol would not correct the primary defect in either condition.
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 |
|---|---|---|---|
| H2466 | Complenatal Ff | Capsule | Not recorded |
| H2466 | Complenatal Ff | Capsule | Not recorded (duplicate entry of the same registration) |
| H2062 (ACT 101) | Filibon | Capsule | Not recorded |
All registered products are oral capsules. Manufacturer and approved indication text are blank in the source data, so the original indication could not be confirmed.
Safety Considerations
Please refer to the SAHPRA-approved Professional Information (PI) for safety information. Report adverse drug reactions to SAHPRA.
The package insert warnings and contraindications have not been retrieved. This is flagged as a blocking gap for safety screening. No drug-interaction records were found.
Conclusion and Next Steps
Decision: Hold
Rationale: The top prediction is an obsolete disease term with no trials, no literature and only model-level support (L5). Safety information is missing, and the original indication cannot be confirmed from the registration data.
To proceed, the following is needed:
- Map “obsolete vitamin D deficiency” to a current vitamin D deficiency concept and re-run the evidence collection.
- Obtain the SAHPRA package inserts (warnings, contraindications, interactions, approved indications) for H2466 and H2062.
- Obtain mechanism of action data from DrugBank (DB00146).
- Confirm the calcifediol content and dose in each registered product, including whether these are multi-ingredient products.
- Optionally, scope a separate feasibility review of vitamin D-dependent rickets type 1B, the only alternative prediction with a clear mechanistic rationale.
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.