Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Danish Cancer Society | OTHER |
| University of Southern Denmark | OTHER |
| K. A. Rohde's and wife's Foundation | OTHER |
| The County of Funen, Denmark |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Selenium enriched-yeast tablet; SelenoPRECISE 100 mcg/d | Experimental |
| |
| Selenium enriched-yeast tablet; SelenoPRECISE 200 mcg/d | Experimental |
| |
| Selenium enriched-yeast tablet; SelenoPRECISE 300 mcg/d | Experimental |
| |
| Yeast tablet | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SelenoPRECISE selenium-enriched yeast tablet, Pharma Nord Denmark A/S | Dietary Supplement |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At five years intervention |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Selenium Centre, Odense University Hospital | Odense C | 5000 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26420334 | Derived | 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. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
| OTHER_GOV |
| Cypress Systems, USA | UNKNOWN |
| The Dagmar Marshall Foundation | OTHER |
| The N. O. Andersen Foundation | UNKNOWN |
| The Danish Directory of Food and Agriculture | UNKNOWN |
| The Foundation of Clinical Experimental Cancer Research, Odense | UNKNOWN |
| The Foundation of Lily Benthine Lund | UNKNOWN |
| The Memory Foundation of Merchant Brogaard | UNKNOWN |
| Pharma Nord | INDUSTRY |
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.
Not provided
Not provided
Not provided
| Up to 17 years |