Ignite Creation Date:
2024-05-05 @ 10:12 PM
Last Modification Date:
2024-10-26 @ 10:15 AM
Study NCT ID:
NCT01052051
Status:
COMPLETED
Last Update Posted:
2019-07-24
First Post:
2010-01-19
Brief Title:
Clinical Trial of Vitamin D3 to Reduce Cancer Risk in Postmenopausal Women
Sponsor:
Creighton University
Organization:
Creighton University
Study Overview
Official Title:
Clinical Trial of Vitamin D3 to Reduce Cancer Risk in Postmenopausal Women
Status:
COMPLETED
Status Verified Date:
2019-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CAPS
Brief Summary:
To determine the effect of increasing serum 25OHD from prevailing levels with vitamin D3 supplementation while maintaining adequate calcium intake on incidence of all-type cancer in a population sample of healthy postmenopausal women
Detailed Description:
Hypotheses
Primary Increasing serum 25OHD from prevailing levels with vitamin D3 supplementation while maintaining adequate calcium intake will significantly decrease incidence of all-type cancer in a population sample of healthy postmenopausal women
Secondary
1 Increasing serum 25OHD from prevailing levels will significantly decrease incidence of specific cancers breast lung colon myeloma leukemia lymphoma
2 Increasing serum 25OHD from prevailing levels will significantly decrease incidence of other disorders specifically hypertension cardiovascular disease osteoarthritis colonic adenomas diabetes upper respiratory infections and falls
Specific Aims
1 Determine the effect of supplementation with vitamin D3 on incidence of all types of cancer combined
2 Determine in a nested-case control study the association of serum 25OHD collected at randomization and at the end of year one of study with risk of cancer over four years
3 Sample randomly the population of healthy independently-living postmenopausal women 55 years and older from twelve adjacent rural counties in Nebraska
4 Enroll a random sample of 2300 women into an intervention study assign them randomly to one of two treatment groups 1 vitamin D3 2000 IUd and calcium 1500 mgd or 2 vitamin D3 placebo and calcium placebo and to follow each study participant for four years
5 Collect and store blood serum and white blood cells from every participant to test for genetic markers should the intervention be found effective in decreasing the incidence of cancer Markers selected will be determined by the state of the science at the time of analysis
6 Determine the effect of supplementation with calcium and vitamin D3 on incidence of specific cancers breast lung colon myeloma leukemia and lymphoma
7 Determine the effect of supplementation on incidence of other disorders specifically hypertension cardiovascular disease osteoarthritis colonic adenomas diabetes upper respiratory infections fractures and falls
Primary Increasing serum 25OHD from prevailing levels with vitamin D3 supplementation while maintaining adequate calcium intake will significantly decrease incidence of all-type cancer in a population sample of healthy postmenopausal women
Secondary
1 Increasing serum 25OHD from prevailing levels will significantly decrease incidence of specific cancers breast lung colon myeloma leukemia lymphoma
2 Increasing serum 25OHD from prevailing levels will significantly decrease incidence of other disorders specifically hypertension cardiovascular disease osteoarthritis colonic adenomas diabetes upper respiratory infections and falls
Specific Aims
1 Determine the effect of supplementation with vitamin D3 on incidence of all types of cancer combined
2 Determine in a nested-case control study the association of serum 25OHD collected at randomization and at the end of year one of study with risk of cancer over four years
3 Sample randomly the population of healthy independently-living postmenopausal women 55 years and older from twelve adjacent rural counties in Nebraska
4 Enroll a random sample of 2300 women into an intervention study assign them randomly to one of two treatment groups 1 vitamin D3 2000 IUd and calcium 1500 mgd or 2 vitamin D3 placebo and calcium placebo and to follow each study participant for four years
5 Collect and store blood serum and white blood cells from every participant to test for genetic markers should the intervention be found effective in decreasing the incidence of cancer Markers selected will be determined by the state of the science at the time of analysis
6 Determine the effect of supplementation with calcium and vitamin D3 on incidence of specific cancers breast lung colon myeloma leukemia and lymphoma
7 Determine the effect of supplementation on incidence of other disorders specifically hypertension cardiovascular disease osteoarthritis colonic adenomas diabetes upper respiratory infections fractures and falls
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01CA129488-01A2 | NIH | None | httpsreporternihgovquickSearchR01CA129488-01A2 |