CancerPhase 2/3CAPSNCT01052051
Clinical Trial of Vitamin D3 to Reduce Cancer Risk in Postmenopausal Women
A Phase 2/3 study testing Vitamin D3 and Calcium carbonate in people with Cancer, run by Creighton University at 1 site in United States.
Trial summary
To determine the effect of increasing serum 25(OH)D 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. Read more about this study
- Who is it for?
- Ages 55 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cancer
- What is being tested?
- Vitamin D3 and Calcium carbonate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,303 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to Aug 2015
- Phase
- Phase 2/3
- 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 55 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age: ≥ 55 years
- Last menstrual period (LMP): ≥ 4 years
- Good general health
- Willingness to participate in this 4 year long study
- Able to give informed consent
- Able to live independently and travel to the Fremont Area Medical Center (FAMC) for study visits
Who cannot join
- History of cancer except
- Superficial basal or squamous cell carcinoma of the skin
- Other malignancies treated curatively more than 10 years ago
- History of renal calculi or chronic kidney disease
- History of sarcoidosis
- History of tuberculosis
- Participation in the previous Creighton cancer prevention study
- Mini-Mental Status Exam (MMSE) score of ≤ 23. Use the MMSE if there are any concerns about the person's cognitive abilities or ability to give fully informed consent to the study. Concerns may be related to a person's lack of orientation to person, place, or time; language difficulties (inability to structure simple, complete sentences); or short term memory. The Hartford Institute for Geriatric Nursing recommends that a score of 23 or lower indicates cognitive impairment. (Accessed at www.harforddign.org). See appendix.
Trial locations and contacts
1 site in 1 country.
United States1 site
Fremont Area Medical Center
Fremont, Nebraska, 68025
About this study
To determine the effect of increasing serum 25(OH)D 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.
Read the detailed description
Hypotheses:
Primary: Increasing serum 25(OH)D 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:
- Increasing serum 25(OH)D from prevailing levels will significantly decrease incidence of specific cancers: breast, lung, colon, myeloma, leukemia, lymphoma.
- 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:
- Determine the effect of supplementation with vitamin D3 on incidence of all types of cancer combined.
- 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.
- Sample randomly the population of healthy independently-living postmenopausal women 55 years and older from twelve adjacent rural counties in Nebraska.
- Enroll a random sample of 2300 women into an intervention study, assign them randomly to one of two treatment groups: 1) vitamin D3 (2000 IU/d) and calcium (1500 mg/d), or 2) vitamin D3 placebo and calcium placebo, and to follow each study participant for four years.
- 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.
- Determine the effect of supplementation with calcium and vitamin D3 on incidence of specific cancers: breast, lung, colon, myeloma, leukemia, and lymphoma.
- Determine the effect of supplementation on incidence of other disorders, specifically hypertension, cardiovascular disease, osteoarthritis, colonic adenomas, diabetes, upper respiratory infections, fractures, and falls.
- Conditions
- Cancer
- Being tested
- Vitamin D3, Calcium carbonate
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3Dietary supplement
Vitamin D3 2000 IU/daily
Calcium carbonateDietary supplement
Calcium carbonate 1500mg / daily
| Study group | Role | What they receive |
|---|---|---|
| vitamin D3 and calcium carbonate | Experimental | Daily vitamin D3 2000 IU/day and calcium carbonate 1500mg/day supplementation Receives: Dietary Supplement: Vitamin D3; Dietary Supplement: Calcium carbonate |
| Placebo for vitamin D3 and calcium carbonate | Placebo comparator | Placebo for daily vitamin D3 and calcium carbonate Receives: Dietary Supplement: Vitamin D3; Dietary Supplement: Calcium carbonate |
What is being measured
The primary outcome is the main question the study is designed to answer.
all-type cancer (excluding non-melanoma skin cancers)
Measured: 4 years
Secondary outcomes (7)
breast cancer
Measured: 4 years
colorectal cancer
Measured: 4 years
new osteoporotic fractures
Measured: 4 years
diagnosis of diabetes mellitus
Measured: 4 years
frequency and severity of asthma symptoms in persons with asthma at baseline
Measured: 4 years
frequency of falls
Measured: 4 years
frequency of colds and flu
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2010 (estimated)
- Study startJun 2009
- Primary completionAug 2015
- Study completionAug 2015
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.
- 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2,303 participants (actual)
Sponsor and investigators
- Lead sponsor
- Creighton University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Joan Lappe, Creighton University
- Investigators
- Joan M Lappe, PhD, Principal investigator, Creighton University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01052051
- Sponsor's protocol ID
- CAPS08-15024
- Other IDs
- R01CA129488-01A2
- Acronym
- CAPS
- Status last verified
- Jul 2019
- First submitted
- 19 Jan 2010
- Last updated
- 24 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lappe J, Watson P, Travers-Gustafson D, Recker R, Garland C, Gorham E, Baggerly K, McDonnell SL. Effect of Vitamin D and Calcium Supplementation on Cancer Incidence in Older Women: A Randomized Clinical Trial. JAMA. 2017 Mar 28;317(12):1234-1243. doi: 10.1001/jama.2017.2115.
PubMed 28350929
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial of Vitamin D3 to Reduce Cancer Risk in Postmenopausal Women
- ClinicalTrials.gov ID
- NCT01052051
- Acronym / sponsor ID
- CAPS / CAPS08-15024
- Conditions
- Cancer
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,303 participants (actual)
- Lead sponsor
- Creighton UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Study start
- Jun 2009
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 20 Jan 2010 (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.
To determine the effect of increasing serum 25(OH)D 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 25(OH)D 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:
- Increasing serum 25(OH)D from prevailing levels will significantly decrease incidence of specific cancers: breast, lung, colon, myeloma, leukemia, lymphoma.
- 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:
- Determine the effect of supplementation with vitamin D3 on incidence of all types of cancer combined.
- 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.
- Sample randomly the population of healthy independently-living postmenopausal women 55 years and older from twelve adjacent rural counties in Nebraska.
- Enroll a random sample of 2300 women into an intervention study, assign them randomly to one of two treatment groups: 1) vitamin D3 (2000 IU/d) and calcium (1500 mg/d), or 2) vitamin D3 placebo and calcium placebo, and to follow each study participant for four years.
- 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.
- Determine the effect of supplementation with calcium and vitamin D3 on incidence of specific cancers: breast, lung, colon, myeloma, leukemia, and lymphoma.
- 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vitamin D3 and calcium carbonate | Experimental | Dietary Supplement: Vitamin D3, Dietary Supplement: Calcium carbonateDaily vitamin D3 2000 IU/day and calcium carbonate 1500mg/day supplementation |
| Placebo for vitamin D3 and calcium carbonate | Placebo comparator | Dietary Supplement: Vitamin D3, Dietary Supplement: Calcium carbonatePlacebo for daily vitamin D3 and calcium carbonate |
Who may qualify
- Ages
- 55 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age: ≥ 55 years
- Last menstrual period (LMP): ≥ 4 years
- Good general health
- Willingness to participate in this 4 year long study
- Able to give informed consent
Key exclusion criteria (8 listed)
- History of cancer except
- History of renal calculi or chronic kidney disease
- History of sarcoidosis
- History of tuberculosis
- Participation in the previous Creighton cancer prevention study
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 |
|---|---|---|
| Vitamin D3Vitamin D3 2000 IU/daily | Dietary supplement | Placebo for vitamin D3 and calcium carbonate, vitamin D3 and calcium carbonate |
| Calcium carbonateCalcium carbonate 1500mg / daily | Dietary supplement | Placebo for vitamin D3 and calcium carbonate, vitamin D3 and calcium carbonate |
Primary outcome
all-type cancer (excluding non-melanoma skin cancers)
Time frame: 4 years
7 secondary outcomes
breast cancer
Time frame: 4 years
colorectal cancer
Time frame: 4 years
new osteoporotic fractures
Time frame: 4 years
diagnosis of diabetes mellitus
Time frame: 4 years
frequency and severity of asthma symptoms in persons with asthma at baseline
Time frame: 4 years
frequency of falls
Time frame: 4 years
frequency of colds and flu
Time frame: 4 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 24 Jul 2019.
- Derived from this study: PubMed 28350929Lappe J, Watson P, Travers-Gustafson D, Recker R, Garland C, Gorham E, Baggerly K, McDonnell SL. Effect of Vitamin D and Calcium Supplementation on Cancer Incidence in Older Women: A Randomized Clinical Trial. JAMA. 2017 Mar 28;317(12):1234-1243. doi: 10.1001/jama.2017.2115.
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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.
Joan M Lappe, PhD principal investigator
Creighton University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Vitamin D3 and Calcium carbonate in people with Cancer, run by Creighton University at 1 site in United States.
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 6 inclusion and 8 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 24 Jul 2019. 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 United States. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
all-type cancer (excluding non-melanoma skin cancers) (time frame: 4 years). 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 NCT01052051, 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 24 Jul 2019.