Dl-Alpha-Tocopherol
| Evidence Level: L3 | Predicted Indications: 10 |
Table of Contents
DL-alpha-Tocopherol: From No Recorded Indication to Immature Cataract
One-Sentence Summary
DL-alpha-Tocopherol is a synthetic form of vitamin E. It is registered in South Africa as a component of an infusion product, and no original indication is recorded in the data. The TxGNN model predicts it may be relevant to immature cataract. Support is thin: 0 registered clinical trials and 1 publication (a 1999 human study).
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not recorded (no approved indication text in the SAHPRA record or DrugBank) |
| Predicted New Indication | Immature cataract |
| TxGNN Prediction Score | 99.98% |
| Evidence Level | L3 |
| 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. Alpha-tocopherol is a lipid-soluble antioxidant that limits lipid peroxidation in cell membranes. That property is the basis for the predicted link to cataract.
Oxidative damage to lens membranes and proteins is a recognised contributor to cataract formation. An antioxidant could therefore plausibly play a protective role. This link has not been tested in this evidence pack. Because no original indication is on record, no similarity between an original and a new indication can be assessed.
The score should be read with caution. TxGNN gave nearly identical scores (about 99.97%) to many cataract subtypes, including mature, tetanic, craniostenosis-associated and diabetic cataract. It also gave a similar score to antithrombin deficiency type 2, which has no plausible link to this drug. This pattern suggests the score reflects proximity in the knowledge graph rather than a signal specific to immature cataract.
The antioxidant rationale applies mainly to prevention or slowing of lens opacity. It is unlikely to reverse an already opacified lens.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 10749028 | 1999 | Human study (randomised, placebo-controlled per abstract; classified as observational, inferred from title only) | Annals of Nutrition & Metabolism | 50 patients with idiopathic immature senile cataract (25 cortical, 25 nuclear) received vitamin E or placebo for 30 days. Lens glutathione, vitamin E, malondialdehyde and glutathione peroxidase were measured. The abstract available here is truncated, so full results are not confirmed. |
This is a small, single study of about 50 patients. It measured biochemical markers in the lens, not vision or cataract progression. It is not evidence of a confirmed treatment effect.
South Africa Market Information
| Registration Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| Reg. No. 36/22.1/0508 | Cernevit | Infusion | Not recorded |
The only registered form is an injectable infusion. Whether an infusion suits a cataract-related use has not been assessed. The route of administration in the 1999 study is not shown in the available abstract.
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 and one small 1999 study of biochemical markers. No clinical trials are registered, and the near-identical scores across unrelated cataract subtypes point to graph artefact rather than a specific signal. Safety data from the SAHPRA package insert is also missing, which blocks progression to safety screening.
To proceed, the following is needed:
- SAHPRA package insert warnings and contraindications (download and parse the PI PDF from the SAHPRA website)
- Mechanism of action data (query the DrugBank API)
- Full-text review of PMID 10749028 to confirm study design, outcomes and route of administration
- A systematic literature search for vitamin E and cataract, including randomised trials and meta-analyses
- Assessment of whether the registered infusion route is compatible with a cataract use
This report is for research reference only and does not constitute medical advice. Repurposing candidates require clinical validation before any clinical application.
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.