Selenium
| Evidence Level: L4 | Predicted Indications: 10 |
Table of Contents
Selenium: From Parenteral Nutrition Trace Element Use to Sclerosing Cholangitis
One-Sentence Summary
Selenium is an essential trace element, and in South Africa it is registered in parenteral nutrition (TPN) type products. The TxGNN model predicts it may be useful for sclerosing cholangitis (score 99.04%), but there are 0 clinical trials and only 5 publications, none of which tests selenium as a treatment. This prediction is not supported by clinical evidence and should be held.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not stated in the SAHPRA registration records. The registered products are TPN-type formulations. |
| Predicted New Indication | Sclerosing cholangitis |
| TxGNN Prediction Score | 99.04% |
| Evidence Level | L4 |
| South Africa Market Status | Marketed |
| Number of SAHPRA Registrations | 15 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data is not available. Selenium is an essential micronutrient and a component of antioxidant selenoenzymes. No established therapeutic rationale links it to sclerosing cholangitis.
The literature only shows an association with the disease state. Patients with primary sclerosing cholangitis (PSC) have altered hepatic selenium and copper levels, and their dietary intake is poor. One case report suggests that oxidative stress and low antioxidant status contribute to cholestatic liver disease. This is not evidence that giving selenium helps. The high TxGNN score should be treated as a hypothesis only.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 9053974 | 1995 | Observational | Scand J Gastroenterol | 32 PSC patients studied for trace element metabolism. Hepatic copper and selenium were retained, which is a disease association. |
| 39601354 | 2025 | Observational (dietary survey) | Liver Int | Dietary intake in PSC was compared with Nordic nutrition recommendations. Fat-soluble vitamin intake and diet quality were poor. |
| 29148959 | 2017 | Case report | JPEN J Parenter Enteral Nutr | One patient with PSC and ulcerative colitis on parenteral nutrition. The report discusses oxidative stress and antioxidant status, and selenium is not tested. |
| 18941372 | 2008 | Review | Eur J Cancer Prev | Colorectal cancer chemoprevention review. Only indirectly relevant. |
| 17109383 | 2006 | Preclinical | Proteomics | Hepatic proteome changes in mouse models of fibrosis and sclerosing cholangitis. No treatment effect of selenium is shown. |
South Africa Market Information
Fifteen registrations are recorded. The five main ones are below. The records give no approved indication text or manufacturer, and Essential Medicines List (EML) status is not provided.
| Registration Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| EXCLUSION UNDER SECTION 36 & SECTION 14 | ITN 5501a 2240ml | Tpn | Not stated |
| ARTICLE 21B N/A | ITN 1606n 150ml | Tpn | Not stated |
| ARTICLE 21B N/A | ITN 3007m 2500ml | Tpn | Not stated |
| EXCLUSION UNDER SECTION 36 & SECTION 14 | ITN 55a 600ml | Tpn | Not stated |
| ARTICLE 21B N/A | ITN 7004a 2520ml | Tpn | Not stated |
The registered routes are infusion (TPN) only.
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:
- There are no clinical trials and no treatment studies in sclerosing cholangitis. The literature only describes altered selenium levels and diet in the disease, so the high model score is unsupported.
- Safety information from the SAHPRA PI has not been obtained, so safety screening cannot start.
Other predicted indications with more evidence (for prioritisation):
- Congestive heart failure (L2):
- One completed Phase 3 trial, the LVAD perioperative high-dose selenium trial (NCT02530788, n=21). No outcome data were supplied.
- Two large Phase 3 trials are not yet reporting: NCT06694727 (recruiting, n=4044) and NCT07234422 (not yet recruiting, n=1100). Both combine selenium with other supplements, so the selenium effect cannot be isolated.
- Observational data suggest a U-shaped association, so both deficiency and excess may be harmful.
- Rheumatoid arthritis (L3): There is a 2025 meta-analysis of selenium supplementation and a 2023 Iranian clinical study on symptoms. Their designs are not confirmed. The one registered trial listed is irrelevant to RA, and the preclinical data are supportive only.
To proceed, the following is needed:
- The SAHPRA package insert warnings and contraindications.
- Mechanism of action data, for example from DrugBank.
- The original approved indication and manufacturer details for the registered products.
- Any controlled human data for selenium in sclerosing cholangitis, if the indication is to be reconsidered. Otherwise, prioritise the heart failure question once the Phase 3 results are available.
This report is for research reference only and does not constitute medical advice. Repurposing candidates require clinical validation before use.
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.