CancerDK PRECISENCT01819649
Selenium in the Prevention of Cancer
A study testing SelenoPRECISE selenium-enriched yeast tablet, Pharma Nord Denmark A/S in people with Cancer, run by Odense University Hospital at 1 site in Denmark.
Trial summary
This is a pilot study proceeding an intended international trial. Hypothesis: Daily intake of selenium supplementation in the form of selenium-enriched yeast tablets will reduce the risk of cancer in healthy individuals. Read more about this study
- Who is it for?
- Ages 60 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Cancer
- What is being tested?
- SelenoPRECISE selenium-enriched yeast tablet, Pharma Nord Denmark A/S
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 491 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 1998to Jun 2004
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- WHO performance status 0 or 1
- No active liver- or kidney disease (Serum ALAT (alanine aminotransferase), alkalic phosphatase, bilirubin, creatinin or urea within 2 S.D of laboratory reference range)
- No previous cancer diagnosis
- No known HIV-infection
- Participant must understand oral and written information
- Participant must not use selenium supplementation of above 50 mcg/d
- Participant must give written consent prior to inclusion
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevention of Cancer by Intervention With Selenium - A Pilot Study in a Danish Population
This is a pilot study proceeding an intended international trial.
Hypothesis: Daily intake of selenium supplementation in the form of selenium-enriched yeast tablets will reduce the risk of cancer in healthy individuals.
Objective: The objective of this pilot study was to assess the viability of a full scale randomised trial.
AMENDMENT TO STUDY OBJECTIVE: Mortality analysis during intervention and follow-up as specified in the sections concerning study design and outcome measures.
- Conditions
- Cancer
- Being tested
- SelenoPRECISE selenium-enriched yeast tablet, Pharma Nord Denmark A/S
- Keywords
- selenium, selenium supplementation, randomised controlled trial, prevention
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SelenoPRECISE selenium-enriched yeast tablet, Pharma Nord Denmark A/SDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Selenium enriched-yeast tablet; SelenoPRECISE 100 mcg/d | Experimental | Not described Receives: Dietary Supplement: SelenoPRECISE selenium-enriched yeast tablet, Pharma Nord Denmark A/S |
| Selenium enriched-yeast tablet; SelenoPRECISE 200 mcg/d | Experimental | Not described Receives: Dietary Supplement: SelenoPRECISE selenium-enriched yeast tablet, Pharma Nord Denmark A/S |
| Selenium enriched-yeast tablet; SelenoPRECISE 300 mcg/d | Experimental | Not described Receives: Dietary Supplement: SelenoPRECISE selenium-enriched yeast tablet, Pharma Nord Denmark A/S |
| Yeast tablet | Placebo comparator | Not described Receives: Dietary Supplement: SelenoPRECISE selenium-enriched yeast tablet, Pharma Nord Denmark A/S |
What is being measured
The primary outcome is the main question the study is designed to answer.
Viability of full scale study
At five years intervention (last participant last visit was june 2004) viability of full scale study was assessed according to the drop out rate, cost etc. of this pilot study.
Measured: At five years intervention
Secondary outcomes (1)
AMENDMENT TO OUTCOME MEASURES: Mortality analysis.
Study participants will be followed up for mortality from the date of randomization in 1998-1999 through March 31, 2015. Vital status and date of death will be obtained from the Danish Civil Registration System. Information on the underlying cause of death will be obtained from the Danish Registry of Causes of Death through December 31, 2010 and from participant medical charts from January 1, 2011. Cause of death will be classified according to the 10th Revision of the International Classification of Diseases as death due to cancer (codes C00-C97), CVD (I00-I99), and all other causes.
Measured: Up to 17 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2013 (estimated)
- Study startNov 1998
- Primary completionJun 2004
- Study completionJun 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- AMENDMENT TO STUDY DESIGN: Towards the end of the intervention period, it was decided to follow-up participants for an additional ten years via Danish public registries for data on morbidity and mortality.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 491 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Danish Cancer Society, University of Southern Denmark, K. A. Rohde's and wife's Foundation, The County of Funen, Denmark, Cypress Systems, USA, The Dagmar Marshall Foundation, The N. O. Andersen Foundation, The Danish Directory of Food and Agriculture, The Foundation of Clinical Experimental Cancer Research, Odense, The Foundation of Lily Benthine Lund, The Memory Foundation of Merchant Brogaard, Pharma Nord
- Responsible party
- Principal investigator, Søren Cold, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01819649
- Sponsor's protocol ID
- OUH-DK-PILOT-PRECISE
- Acronym
- DK PRECISE
- Status last verified
- Sep 2017
- First submitted
- 23 Jan 2013
- Last updated
- 14 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cold F, Winther KH, Pastor-Barriuso R, Rayman MP, Guallar E, Nybo M, Griffin BA, Stranges S, Cold S. Randomised controlled trial of the effect of long-term selenium supplementation on plasma cholesterol in an elderly Danish population. Br J Nutr. 2015 Dec 14;114(11):1807-18. doi: 10.1017/S0007114515003499. Epub 2015 Sep 30.
PubMed 26420334
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Cancer by Intervention With Selenium - A Pilot Study in a Danish Population
- ClinicalTrials.gov ID
- NCT01819649
- Acronym / sponsor ID
- DK PRECISE / OUH-DK-PILOT-PRECISE
- Conditions
- Cancer
- Keywords
- selenium, selenium supplementation, randomised controlled trial, prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 491 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Collaborators
- Danish Cancer Society, University of Southern Denmark, K. A. Rohde's and wife's Foundation, The County of Funen, Denmark, Cypress Systems, USA, The Dagmar Marshall Foundation, The N. O. Andersen Foundation, The Danish Directory of Food and Agriculture, The Foundation of Clinical Experimental Cancer Research, Odense, The Foundation of Lily Benthine Lund, The Memory Foundation of Merchant Brogaard, Pharma Nord
- Study start
- Nov 1998
- Primary completion
- Jun 2004 (actual)
- Study completion
- Jun 2004 (actual)
- First posted
- 27 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a pilot study proceeding an intended international trial.
Hypothesis: Daily intake of selenium supplementation in the form of selenium-enriched yeast tablets will reduce the risk of cancer in healthy individuals.
Objective: The objective of this pilot study was to assess the viability of a full scale randomised trial.
AMENDMENT TO STUDY OBJECTIVE: Mortality analysis during intervention and follow-up as specified in the sections concerning study design and outcome measures.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
- Model description
- AMENDMENT TO STUDY DESIGN: Towards the end of the intervention period, it was decided to follow-up participants for an additional ten years via Danish public registries for data on morbidity and mortality.
| Arm | Type | Receives |
|---|---|---|
| Selenium enriched-yeast tablet; SelenoPRECISE 100 mcg/d | Experimental | Dietary Supplement: SelenoPRECISE selenium-enriched yeast tablet, Pharma Nord Denmark A/S |
| Selenium enriched-yeast tablet; SelenoPRECISE 200 mcg/d | Experimental | Dietary Supplement: SelenoPRECISE selenium-enriched yeast tablet, Pharma Nord Denmark A/S |
| Selenium enriched-yeast tablet; SelenoPRECISE 300 mcg/d | Experimental | Dietary Supplement: SelenoPRECISE selenium-enriched yeast tablet, Pharma Nord Denmark A/S |
| Yeast tablet | Placebo comparator | Dietary Supplement: SelenoPRECISE selenium-enriched yeast tablet, Pharma Nord Denmark A/S |
Who may qualify
- Ages
- 60 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- WHO performance status 0 or 1
- No active liver- or kidney disease (Serum ALAT (alanine aminotransferase), alkalic phosphatase, bilirubin, creatinin or urea within 2 S.D of laboratory reference range)
- No previous cancer diagnosis
- No known HIV-infection
- Participant must understand oral and written information
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SelenoPRECISE selenium-enriched yeast tablet, Pharma Nord Denmark A/S | Dietary supplement | Selenium enriched-yeast tablet; SelenoPRECISE 100 mcg/d, Selenium enriched-yeast tablet; SelenoPRECISE 200 mcg/d, Selenium enriched-yeast tablet; SelenoPRECISE 300 mcg/d, Yeast tablet |
Primary outcome
Viability of full scale study
Time frame: At five years intervention
At five years intervention (last participant last visit was june 2004) viability of full scale study was assessed according to the drop out rate, cost etc. of this pilot study.
1 secondary outcome
AMENDMENT TO OUTCOME MEASURES: Mortality analysis.
Time frame: Up to 17 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2017.
- Derived from this study: PubMed 26420334Cold F, Winther KH, Pastor-Barriuso R, Rayman MP, Guallar E, Nybo M, Griffin BA, Stranges S, Cold S. Randomised controlled trial of the effect of long-term selenium supplementation on plasma cholesterol in an elderly Danish population. Br J Nutr. 2015 Dec 14;114(11):1807-18. doi: 10.1017/S0007114515003499. Epub 2015 Sep 30.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SelenoPRECISE selenium-enriched yeast tablet, Pharma Nord Denmark A/S in people with Cancer, run by Odense University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Viability of full scale study (time frame: At five years intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01819649, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2017.