Calcium Ascorbate
| Evidence Level: L5 | Predicted Indications: 10 |
Table of Contents
Calcium Ascorbate: From an Unspecified Original Indication to Insomnia
One-Sentence Summary
Calcium ascorbate is a calcium salt of vitamin C (ascorbic acid). The supplied data records no original indication for it. The TxGNN model predicts it may be effective for insomnia, but this is a model prediction only. There are 0 clinical trials and 0 publications supporting it.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not stated in the supplied registration data |
| Predicted New Indication | Insomnia |
| TxGNN Prediction Score | 95.15% |
| Evidence Level | L5 |
| South Africa Market Status | Marketed |
| Number of SAHPRA Registrations | 3 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data is not available. Calcium ascorbate is a vitamin C salt, and no established link between it and sleep regulation is documented in the supplied data.
The original indications field is empty, so the relationship between the original and predicted indication cannot be assessed. The high score (0.951) is a graph-based model output. No trial or publication corroborates it, and it should not be read as evidence of efficacy.
Other high-scoring predictions for this drug are mostly cataract subtypes and diabetic retinopathy. An antioxidant rationale (oxidative stress in the lens and retina) is at least conceivable there, though it is also unverified. Several cataract nodes share an identical score (0.942), which suggests a shared-neighbourhood artefact rather than a drug-specific signal.
Clinical Trial Evidence
Currently no related clinical trials registered (ClinicalTrials.gov, ICTRP, SANCTR or PACTR records were not supplied).
Literature Evidence
Currently no related literature available.
South Africa Market Information
| Registration Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| P/7.1.4/281 | Nitrolingual | Inhaler | Not stated in the supplied data |
| C769 (ACT 101/1965) | Ilvico | Syrup | Not stated in the supplied data |
| C770 (ACT 101/1965) | Ilvico | Tablet | Not stated in the supplied data |
Data quality note: Nitrolingual is, to my knowledge, a glyceryl trinitrate product rather than a vitamin C product, so this registration may be an ingredient-mapping error. It should be checked against the SAHPRA register before any of these registrations are relied on. Approved indication text and manufacturer are blank for all three entries.
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 rests on a model score alone (L5), with no trials, no publications and no plausible mechanism identified. Safety information is also missing, so this candidate cannot proceed to safety screening.
To proceed, the following is needed:
- The SAHPRA package insert (warnings and contraindications), which is currently a blocking gap
- Mechanism of action data, for example from DrugBank
- Verification of the three SAHPRA registrations, especially the Nitrolingual entry, and their approved indications
- A systematic literature search on vitamin C and sleep or insomnia
- Consideration of the antioxidant-related predictions (cataract, diabetic retinopathy) as separate research questions, each starting with a literature review
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.