drugset / Trial / NCT01437826
Antioxidant Supplement and Reduction of Metachronous Adenomas of the Large Bowel: a Double Blind Randomized Trial
Phase 3
Terminated
411 enrolled
IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
LILT (Italian league against cancer) · collab
RandomizedParallel-groupDouble-blindPrevention
Summary
The trial was aimed at evaluating the efficacy of a multiagent antioxidant compound (vitamin A, C, E, selenium and zinc) in reducing the incidence of metachronous adenomas of the large bowel after endoscopic polypectomy. This is a randomized study: a 50% reduction in the incidence of metachronous adenomas was expected in patients allocated to the "active" compound (intervention) arm as compared to those assigned to a placebo.
Timeline
- Start
- 1988-03
- Primary completion
- 1996-06
- Completion
- 1996-06
Outcome
Outcome not reported
Stopped: “50% of eligible patients refused to enter the study”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Selenium | Other / unclassified | 200 ug | — |
| Subject | Vitamin A | Unknown | 2 mg | — |
| Subject | Vitamin C | Other / unclassified | 180 mg | — |
| Subject | Vitamin E | Other / unclassified | 30 mg | — |
| Subject | Zinc Sulfate | Unknown | 30 mg | — |