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Optimal Selenium for Bowel Polyps (OSCAR)

NCT04952129 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2025-01-22

No results posted yet for this study

Summary

New Zealand (NZ) has high bowel cancer rates, which the Bowel Screening Programme aims to reduce by early detection of bowel cancer and its precursor, adenomas (polyps). Bowel cancer and adenoma rates are higher in countries like NZ with low intake of the essential trace mineral selenium. Overseas, trials of selenium supplements reduced adenoma recurrence in people with low blood selenium, but not with high levels (where adding selenium increased health risks). Laboratory research explained this, and found certain types of selenium are safer and more effective. The optimal type and dose of selenium to use in NZ cancer prevention trials is not known.

The goal of this clinical trial is to find out how to achieve the optimal amount of body selenium in people who have had a high risk bowel adenoma removed. The main questions it aims to answer are:

* what dose of selenium taken by mouth will maximise levels of the main selenium protein in blood;
* whether one type of organic selenium is better than the other at increasing blood levels of this selenium protein;
* whether a larger dose of selenium is needed in people who start with lower blood selenium levels;

Participants will take one selenium capsule a day for 6 weeks then two capsules a day for 6 weeks. Each participant will have blood tests at baseline, then blood tests and evaluation of side effects at 6 weeks and 12 weeks.

Researchers will compare these results in the participants taking each type of selenium (selenomethionine or methylselenocysteine).

Conditions

  • Colorectal Adenoma

Interventions

DRUG

Selenomethionine

Seleno-amino acid

DRUG

Methylselenocysteine

Seleno-amino acid

Sponsors & Collaborators

  • Cancer Trials New Zealand

    collaborator OTHER

  • Counties Manukau Health

    collaborator OTHER

  • Waikato Hospital

    collaborator OTHER

  • University of Auckland, New Zealand

    lead OTHER

Principal Investigators

  • Michael Jameson, PhD · University of Auckland, New Zealand

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-06
Primary Completion
2023-12-11
Completion
2023-12-11

Countries

  • New Zealand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04952129 on ClinicalTrials.gov