Gastrointestinal CancersPhase 1NCT00585637
Vitamin D for Chemoprevention
A Phase 1 study testing Vitamin D in people with Gastrointestinal Cancers and Prostate Cancer, run by Dana-Farber Cancer Institute at 1 site in United States.
Trial summary
This study will help us know the effects of Vitamin D pills in Blacks. The results of this study may be the first step in creating ways to prevent the risks of colon and prostate cancer. It will also help us develop ways to reduce colon cancer and prostate cancer among Blacks. Read more about this study
- Who is it for?
- Ages 30 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastrointestinal Cancers, Prostate Cancer, Hypertension
- What is being tested?
- Vitamin D
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 328 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to Dec 2013
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 30 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Between the ages of 30 and 80 years
- Comfortable communicating in English
- Currently has a primary care physician
- Willing to discontinue vitamin D or calcium supplements
- Willing to have all protocol specific tests run
Who cannot join
- Plans on taking a vacation or travel to a sunny region within 3 months of vitamin supplementation period except for a short period (i.e. 1 weekend)
- Pregnant or breast feeding or planning on becoming pregnant in the following year
- Pre-existing calcium (including hypercalcemia), parathyroid conditions (including hyperparathyroidism), sarcoidosis
- No concurrent active malignancies (other than non-melanoma skin cancer) or previous diagnosis of prostate cancer
- Cognitively impaired
- Active thyroid disease (e.g. Graves, Hashimoto's or thyroiditis)
- History of nephrolithiasis, chronic liver disease, chronic renal disease, or renal dialysis
Trial locations and contacts
1 site in 1 country.
United States1 site
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
About this study
Official title: Defining Optimal Doses of Vitamin D for Chemoprevention in Blacks.
This study will help us know the effects of Vitamin D pills in Blacks. The results of this study may be the first step in creating ways to prevent the risks of colon and prostate cancer. It will also help us develop ways to reduce colon cancer and prostate cancer among Blacks. This study will find out if Vitamin D pills can increase Vitamin D to healthy levels in our bodies.
Read the detailed description
- Participants will be asked to answer some questions about their diet, exercise and health. In addition, participants blood pressure will be taken. These assessments will occur at baseline, 3- and 6-month appointments. At baseline only, we will measure skin tone with a tool called the Photovolt 577.
- A small blood sample will be taken to see how much Vitamin D is the body and will also look at levels of other markers of disease such as proteins, hormones, and genes.
- Participants will take a vitamin pill every day for three months and be randomly assigned to one of four different types of pills.
- Participants will be called or visited at least every two weeks. They will be asked questions to determine if they have any side effects associated with high levels of Vitamin D.
- At the beginning of the second and third months, participants will be provided with more pills. At the end of the third month, another blood sample will be taken. Three months after that, the final blood sample will be taken.
- Conditions
- Gastrointestinal Cancers, Prostate Cancer, Hypertension
- Being tested
- Vitamin D, Placebo
- Keywords
- Vitamin D, Blacks, cancer, hypertension
- Medical subject headings
- Gastrointestinal Neoplasms, Prostatic Neoplasms, Hypertension, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DDrug
Taken orally every day for three months
PlaceboDietary supplement
Placebo pill taken once daily for 3 month
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | No Vitamin D Receives: Dietary Supplement: Placebo |
| 2 | Active comparator | 1000 IU of Vitamin D Receives: Drug: Vitamin D |
| 3 | Active comparator | 2000 IU of Vitamin D Receives: Drug: Vitamin D |
| 4 | Active comparator | 4000 IU of Vitamin D Receives: Drug: Vitamin D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Levels of Plasma 25(OH)D at Baseline, 3 Months and 6 Months.
Among Blacks, identify a dose of oral vitamin D supplementation that will result in levels of plasma 25(OH)D that would be predicted to reduce colorectal cancer incidence. Community-based African Americans drawn from the Open Doors to Health, which is a colorectal cancer prevention study in 1554 subjects from 12 public-housing communities and community- and faith-based organizations in Boston.
Measured: Baseline, 3months, 6months
Secondary outcomes (4)
Change in IL-6 From 0 to 3 Months.
Examine the influence of oral vitamin D supplementation on inflammatory marker IL-6 from baseline to the 3 month follow-up.
Measured: From baseline to 3 months
Change in IL-10 From 0 to 3 Months.
Examine the influence of oral vitamin D supplementation on inflammatory marker IL-10 from baseline to the 3 month follow-up.
Measured: From baseline to 3 months
Change in sTNF-R2 From 0 to 3 Months.
Examine the influence of oral vitamin D supplementation on inflammatory marker sTNF-R2 from baseline to the 3 month follow-up.
Measured: From baseline to 3 months
Change in CRP From 0 to 3 Months.
Examine the influence of oral vitamin D supplementation on inflammatory marker CRP from baseline to the 3 month follow-up.
Measured: From baseline to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2008 (estimated)
- Study startOct 2007
- Primary completionOct 2010
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Gastrointestinal CancersStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 328 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Harvard School of Public Health (HSPH)
- Responsible party
- Principal investigator, Kimmie Ng, MD, Dana-Farber Cancer Institute
- Investigators
- Edward Giovannucci, MD, ScD, Principal investigator, Harvard School of Public Health/Brigham and Women's HospitalGary G Bennett, PhD, Study director, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00585637
- Sponsor's protocol ID
- 07-342
- Other IDs
- P15192
- Status last verified
- Mar 2015
- First submitted
- 24 Dec 2007
- Last updated
- 1 Apr 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Chandler PD, Scott JB, Drake BF, Ng K, Forman JP, Chan AT, Bennett GG, Hollis BW, Giovannucci EL, Emmons KM, Fuchs CS. Risk of hypercalcemia in blacks taking hydrochlorothiazide and vitamin D. Am J Med. 2014 Aug;127(8):772-8. doi: 10.1016/j.amjmed.2014.02.044. Epub 2014 Mar 20.
PubMed 24657333Ng K, Scott JB, Drake BF, Chan AT, Hollis BW, Chandler PD, Bennett GG, Giovannucci EL, Gonzalez-Suarez E, Meyerhardt JA, Emmons KM, Fuchs CS. Dose response to vitamin D supplementation in African Americans: results of a 4-arm, randomized, placebo-controlled trial. Am J Clin Nutr. 2014 Mar;99(3):587-98. doi: 10.3945/ajcn.113.067777. Epub 2013 Dec 24.
PubMed 24368437Chandler PD, Scott JB, Drake BF, Ng K, Manson JE, Rifai N, Chan AT, Bennett GG, Hollis BW, Giovannucci EL, Emmons KM, Fuchs CS. Impact of vitamin D supplementation on inflammatory markers in African Americans: results of a four-arm, randomized, placebo-controlled trial. Cancer Prev Res (Phila). 2014 Feb;7(2):218-25. doi: 10.1158/1940-6207.CAPR-13-0338-T. Epub 2013 Dec 10.
PubMed 24327720Chandler PD, Agboola F, Ng K, Scott JB, Drake BF, Bennett GG, Chan AT, Hollis BW, Emmons KM, Fuchs CS, Giovannucci EL. Reduction of Parathyroid Hormone with Vitamin D Supplementation in Blacks: A Randomized Controlled Trial. BMC Nutr. 2015;1:26. doi: 10.1186/s40795-015-0024-8. Epub 2015 Dec 17.
PubMed 26858840Chandler PD, Giovannucci EL, Scott JB, Bennett GG, Ng K, Chan AT, Hollis BW, Emmons KM, Fuchs CS, Drake BF. Null association between vitamin D and PSA levels among black men in a vitamin D supplementation trial. Cancer Epidemiol Biomarkers Prev. 2014 Sep;23(9):1944-7. doi: 10.1158/1055-9965.EPI-14-0522. Epub 2014 Jun 28.
PubMed 24974387Forman JP, Scott JB, Ng K, Drake BF, Suarez EG, Hayden DL, Bennett GG, Chandler PD, Hollis BW, Emmons KM, Giovannucci EL, Fuchs CS, Chan AT. Effect of vitamin D supplementation on blood pressure in blacks. Hypertension. 2013 Apr;61(4):779-85. doi: 10.1161/HYPERTENSIONAHA.111.00659.
PubMed 23487599
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Defining Optimal Doses of Vitamin D for Chemoprevention in Blacks.
- ClinicalTrials.gov ID
- NCT00585637
- Acronym / sponsor ID
- 07-342
- Conditions
- Gastrointestinal Cancers, Prostate Cancer, Hypertension
- Keywords
- Vitamin D, Blacks, cancer, hypertension
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 328 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- Harvard School of Public Health (HSPH)
- Study start
- Oct 2007
- Primary completion
- Oct 2010 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 3 Jan 2008 (estimated)
- Results
- Posted 1 Apr 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will help us know the effects of Vitamin D pills in Blacks. The results of this study may be the first step in creating ways to prevent the risks of colon and prostate cancer. It will also help us develop ways to reduce colon cancer and prostate cancer among Blacks. This study will find out if Vitamin D pills can increase Vitamin D to healthy levels in our bodies.
Detailed description
- Participants will be asked to answer some questions about their diet, exercise and health. In addition, participants blood pressure will be taken. These assessments will occur at baseline, 3- and 6-month appointments. At baseline only, we will measure skin tone with a tool called the Photovolt 577.
- A small blood sample will be taken to see how much Vitamin D is the body and will also look at levels of other markers of disease such as proteins, hormones, and genes.
- Participants will take a vitamin pill every day for three months and be randomly assigned to one of four different types of pills.
- Participants will be called or visited at least every two weeks. They will be asked questions to determine if they have any side effects associated with high levels of Vitamin D.
- At the beginning of the second and third months, participants will be provided with more pills. At the end of the third month, another blood sample will be taken. Three months after that, the final blood sample will be taken.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Dietary Supplement: PlaceboNo Vitamin D |
| 2 | Active comparator | Drug: Vitamin D1000 IU of Vitamin D |
| 3 | Active comparator | Drug: Vitamin D2000 IU of Vitamin D |
| 4 | Active comparator | Drug: Vitamin D4000 IU of Vitamin D |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Between the ages of 30 and 80 years
- Comfortable communicating in English
- Currently has a primary care physician
- Willing to discontinue vitamin D or calcium supplements
- Willing to have all protocol specific tests run
Key exclusion criteria (7 listed)
- Plans on taking a vacation or travel to a sunny region within 3 months of vitamin supplementation period except for a short period (i.e. 1 weekend)
- Pregnant or breast feeding or planning on becoming pregnant in the following year
- Pre-existing calcium (including hypercalcemia), parathyroid conditions (including hyperparathyroidism), sarcoidosis
- No concurrent active malignancies (other than non-melanoma skin cancer) or previous diagnosis of prostate cancer
- Cognitively impaired
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 DTaken orally every day for three months | Drug | 2, 3, 4 |
| PlaceboPlacebo pill taken once daily for 3 month | Dietary supplement | 1 |
Primary outcome
Levels of Plasma 25(OH)D at Baseline, 3 Months and 6 Months.
Time frame: Baseline, 3months, 6months
Among Blacks, identify a dose of oral vitamin D supplementation that will result in levels of plasma 25(OH)D that would be predicted to reduce colorectal cancer incidence. Community-based African Americans drawn from the Open Doors to Health, which is a colorectal cancer prevention study in 1554 subjects from 12 public-housing communities and community- and faith-based organizations in Boston.
4 secondary outcomes
Change in IL-6 From 0 to 3 Months.
Time frame: From baseline to 3 months
Change in IL-10 From 0 to 3 Months.
Time frame: From baseline to 3 months
Change in sTNF-R2 From 0 to 3 Months.
Time frame: From baseline to 3 months
Change in CRP From 0 to 3 Months.
Time frame: From baseline to 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 24657333Chandler PD, Scott JB, Drake BF, Ng K, Forman JP, Chan AT, Bennett GG, Hollis BW, Giovannucci EL, Emmons KM, Fuchs CS. Risk of hypercalcemia in blacks taking hydrochlorothiazide and vitamin D. Am J Med. 2014 Aug;127(8):772-8. doi: 10.1016/j.amjmed.2014.02.044. Epub 2014 Mar 20.
- Results publication: PubMed 24368437Ng K, Scott JB, Drake BF, Chan AT, Hollis BW, Chandler PD, Bennett GG, Giovannucci EL, Gonzalez-Suarez E, Meyerhardt JA, Emmons KM, Fuchs CS. Dose response to vitamin D supplementation in African Americans: results of a 4-arm, randomized, placebo-controlled trial. Am J Clin Nutr. 2014 Mar;99(3):587-98. doi: 10.3945/ajcn.113.067777. Epub 2013 Dec 24.
- Results publication: PubMed 24327720Chandler PD, Scott JB, Drake BF, Ng K, Manson JE, Rifai N, Chan AT, Bennett GG, Hollis BW, Giovannucci EL, Emmons KM, Fuchs CS. Impact of vitamin D supplementation on inflammatory markers in African Americans: results of a four-arm, randomized, placebo-controlled trial. Cancer Prev Res (Phila). 2014 Feb;7(2):218-25. doi: 10.1158/1940-6207.CAPR-13-0338-T. Epub 2013 Dec 10.
- Derived from this study: PubMed 26858840Chandler PD, Agboola F, Ng K, Scott JB, Drake BF, Bennett GG, Chan AT, Hollis BW, Emmons KM, Fuchs CS, Giovannucci EL. Reduction of Parathyroid Hormone with Vitamin D Supplementation in Blacks: A Randomized Controlled Trial. BMC Nutr. 2015;1:26. doi: 10.1186/s40795-015-0024-8. Epub 2015 Dec 17.
- Derived from this study: PubMed 24974387Chandler PD, Giovannucci EL, Scott JB, Bennett GG, Ng K, Chan AT, Hollis BW, Emmons KM, Fuchs CS, Drake BF. Null association between vitamin D and PSA levels among black men in a vitamin D supplementation trial. Cancer Epidemiol Biomarkers Prev. 2014 Sep;23(9):1944-7. doi: 10.1158/1055-9965.EPI-14-0522. Epub 2014 Jun 28.
- Derived from this study: PubMed 23487599Forman JP, Scott JB, Ng K, Drake BF, Suarez EG, Hayden DL, Bennett GG, Chandler PD, Hollis BW, Emmons KM, Giovannucci EL, Fuchs CS, Chan AT. Effect of vitamin D supplementation on blood pressure in blacks. Hypertension. 2013 Apr;61(4):779-85. doi: 10.1161/HYPERTENSIONAHA.111.00659.
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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.
Edward Giovannucci, MD, ScD principal investigator
Harvard School of Public Health/Brigham and Women's Hospital
Gary G Bennett, PhD study director
Dana-Farber Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Vitamin D in people with Gastrointestinal Cancers and Prostate Cancer, run by Dana-Farber Cancer Institute 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 5 inclusion and 7 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 1 Apr 2015. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Apr 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Levels of Plasma 25(OH)D at Baseline, 3 Months and 6 Months. (time frame: Baseline, 3months, 6months). 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 NCT00585637, which also lists 6 linked publications.
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 1 Apr 2015.