Vitamin E
| Evidence Level: L5 | Predicted Indications: 10 |
Table of Contents
Vitamin E: Inborn disorder of bilirubin metabolism
One-Sentence Summary
Vitamin E was originally used to treat cholestasis-related conditions and vitamin E deficiency (including familial isolated vitamin E deficiency). The TxGNN model predicts it may be effective for inborn disorder of bilirubin metabolism, but this is a model prediction only, with 0 registered clinical trials and 1 loosely related publication supporting it.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not recorded in the local data |
| Predicted New Indication | Inborn disorder of bilirubin metabolism |
| TxGNN Prediction Score | 0.9999 |
| Evidence Level | L5 |
| India Market Status | Listed in a compiled Indian medicine price dataset (7 of 7) – CDSCO approval status is not included in this data |
| Number of Listed Products | 7 (valid: 7) |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data is not available. Based on known information, vitamin E (alpha-tocopherol) is a fat-soluble antioxidant. Its role in cholestatic liver disease is well recognised, because impaired bile flow reduces absorption of fat-soluble vitamins, and vitamin E supplementation is used to correct the resulting deficiency.
The predicted indication is a group of inherited disorders of bilirubin handling, which often present with cholestasis or jaundice. This overlap with the original cholestasis indications is probably what drives the model’s prediction. The only retrieved paper (PMID 7915305, 1994) describes a bile acid synthesis defect (3β-hydroxy-C27-steroid dehydrogenase deficiency) as a cause of progressive intrahepatic cholestasis. It is not a study of vitamin E. Any benefit would most plausibly be supportive, by correcting vitamin E deficiency, rather than disease-modifying for bilirubin metabolism. The very high TxGNN score is a prediction and not proof of efficacy.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 7915305 | 1994 | Case series | The Journal of Pediatrics | Screening of 30 children with progressive intrahepatic cholestasis (Byler disease) identified 3β-hydroxy-C27-steroid dehydrogenase/isomerase deficiency, a bile acid synthesis defect, as a new cause. Vitamin E was not studied. |
Related evidence was also retrieved for the closely related prediction “bilirubin metabolism disease”. Examples include a cohort study of fat-soluble vitamin/TPGS supplementation in infants with biliary atresia (22891232, Pediatrics, 2012) and a small 1979 study of intramuscular vitamin E and neonatal bilirubinemia in preterm infants (481976, Pediatrics). These are indirect and do not show disease-modifying efficacy.
India Market Information
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| 638 | Antoxid E Softgel Capsule (Dr Reddy’s Laboratories Ltd) | Strip of 15 capsules | Not stated in the records |
| 150973 | NE 400 Soft Gelatin Capsule (Cachet Pharmaceuticals Pvt Ltd) | Strip of 15 soft gelatin capsules | Not stated in the records |
| 217328 | Tocshot Capsule (Kenmed Pharma Private Limited) | Strip of 10 soft gelatin capsules | Not stated in the records |
| 246736 | Zevion 400 Capsule (Zeelab Pharmacy Pvt Ltd) | Strip of 10 capsules | Not stated in the records |
| 73627 | E-Gen 400 Capsule (Hnf Care Pvt Ltd) | Strip of 10 capsules | Not stated in the records |
Seven oral registrations are valid in total, and none has been cancelled. All are oral capsule products.
Review correction (2026-11-06): Originally stated: “Seven single-ingredient oral registrations are valid in total, and none has been cancelled.” Removed: it described the products as single-ingredient or combination products in a way that did not match the Indian medicine data (the Indian Medicine Dataset as of 2026-11-06). Source: Indian Medicine Dataset.
Safety Considerations
Drug Interactions: The interaction screen identified 173 potential interactions. Most of those listed are minor (for example, corticosteroids such as hydrocortisone, prednisone and dexamethasone, and orlistat). The following are moderate:
- Antiplatelet and anticoagulant agents: acetylsalicylic acid, abciximab, apixaban, dipyridamole, betrixaban, bivalirudin, cangrelor, caplacizumab and antithrombin III (human). These may carry additive bleeding risk.
- Iron and phosphate binders: iron, iron sucrose and sevelamer.
Please refer to the package insert for warnings and contraindications.
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction rests on a high model score alone. No clinical trials exist, and the only retrieved paper does not study vitamin E. At best, vitamin E would be a supportive therapy for fat-soluble vitamin deficiency in cholestatic patients, not a treatment for bilirubin metabolism disorders.
To proceed, the following is needed:
- Package insert warnings and contraindications for the Indian-marketed products (currently missing, which blocks safety screening)
- Detailed mechanism of action data
- Direct evidence, such as case series or trials of vitamin E in inherited bilirubin metabolism disorders
- A clear definition of the intended use (supportive vitamin E replacement versus disease-modifying therapy)
- A review of the bleeding-risk interactions with anticoagulant and antiplatelet drugs
Review Log
Below is the review log for this page: statements checked against official Indian medicine data (the Indian Medicine Dataset used by this site). Corrections are limited to basic factual statements; model predictions, evidence levels, and conclusions were not rewritten.
| Review date | Item | Action | Source |
|---|---|---|---|
| 2026-11-06 | Removed: “single-ingredient” | Corrected | Indian Medicine Dataset |
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.