CompletedNCT00585637Updated Apr 1, 2015Results posted

Vitamin D for Chemoprevention

A Phase 1 interventional study of Vitamin D and Placebo in Gastrointestinal Cancers, Prostate Cancer and Hypertension, sponsored by Dana-Farber Cancer Institute. Completed at 1 site in United States. Open to participants aged 30 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-04-01.

Sponsored by Dana-Farber Cancer Institute · Phase 1, Interventional, and Prevention

Phase: Phase 1
Study type: Interventional
Enrollment: 328
Allocation: Randomized
Ages: 30 Years to 80 Years
Sex: All

Study 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. 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 studied

Gastrointestinal Cancers
Prostate Cancer
Hypertension

Browse trials for

Keywords

Vitamin D
Blacks
cancer
hypertension

In context

Gastrointestinal Neoplasms

779 studies on the registry are indexed under Gastrointestinal Neoplasms; 231 are open to participants now.

This study's enrollment of 328 is above the median of 60 across 569 interventional studies indexed under Gastrointestinal Neoplasms.

Browse Gastrointestinal Neoplasms studies →

Lead sponsor

Dana-Farber Cancer Institute is the lead sponsor of 813 studies on the registry; 124 are open to participants now.

Of its 113 completed or terminated interventional studies of FDA-regulated products, 77 (68%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 30 Years to 80 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Study design

Phase: Phase 1
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Single group
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 328 participants (actual)

Study arms

Active comparator
1
No Vitamin D
Dietary Supplement: Placebo
Active comparator
2
1000 IU of Vitamin D
Drug: Vitamin D
Active comparator
3
2000 IU of Vitamin D
Drug: Vitamin D
Active comparator
4
4000 IU of Vitamin D
Drug: Vitamin D

Interventions

DrugVitamin D
Taken orally every day for three months
Dietary supplementPlacebo
Placebo pill taken once daily for 3 month

What researchers measure

Primary outcomes

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.
Time frame: Baseline, 3months, 6months

Secondary outcomes

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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From baseline to 3 months

Results

Posted Apr 1, 2015

Participant flow

This study recruited community-based African American (www.clinicaltrials.gov; NCT00585637). Participants were 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.

Baseline

Participant flow — Baseline
Milestone	No Vitamin D	1000 IU of Vitamin D	2000 IU of Vitamin D	4000 IU of Vitamin D
Started	81	81	83	83
Completed	81	81	83	83
Not completed	0	0	0	0

3-month Time Point

Participant flow — 3-month Time Point
Milestone	No Vitamin D	1000 IU of Vitamin D	2000 IU of Vitamin D	4000 IU of Vitamin D
Started	81	81	83	83
Completed	71	67	76	78
Not completed	10	14	7	5

6-month Time Point

Participant flow — 6-month Time Point
Milestone	No Vitamin D	1000 IU of Vitamin D	2000 IU of Vitamin D	4000 IU of Vitamin D
Started	81	81	83	83
Completed	75	68	72	77
Not completed	6	13	11	6

Outcome measures

PrimaryLevels 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.

Time frame:: Baseline, 3months, 6months
Reported as:: Median · ng/mL

Levels of Plasma 25(OH)D at Baseline, 3 Months and 6 Months.
ng/mL	No Vitamin D	1000 IU of Vitamin D	2000 IU of Vitamin D	4000 IU of Vitamin D
Baseline 25(OH)D	15.1 (10.4 to 23.6)	16.2 (11.0 to 22.7)	13.9 (9.5 to 22.3)	15.7 (11.0 to 23.3)
25(OH)D at 3 months	13.7 (7.2 to 18.6)	29.7 (25.6 to 32.9)	34.8 (28.8 to 41.0)	45.9 (39.4 to 55.2)
25(OH)D at 6 months	18.1 (12.2 to 23.3)	21.2 (16.8 to 27.8)	27.0 (20.6 to 31.1)	31.2 (26.5 to 35.9)

SecondaryChange 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.

Time frame:: From baseline to 3 months
Reported as:: Median · pg/mL

Change in IL-6 From 0 to 3 Months.
pg/mL	No Vitamin D	1000 IU of Vitamin D	2000 IU of Vitamin D	4000 IU of Vitamin D
Change in IL-6 From 0 to 3 Months.	-0.03 (-0.96 to 0.88)	-0.07 (-1.07 to 0.93)	0.01 (-0.57 to 0.89)	0.08 (-0.61 to 0.71)

SecondaryChange 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.

Time frame:: From baseline to 3 months
Reported as:: Median · pg/mL

Change in IL-10 From 0 to 3 Months.
pg/mL	No Vitamin D	1000 IU of Vitamin D	2000 IU of Vitamin D	4000 IU of Vitamin D
Change in IL-10 From 0 to 3 Months.	0 (-0.06 to 0.07)	-0.01 (-0.08 to 0.02)	-0.02 (-0.09 to 0.02)	0.00 (-0.06 to 0.04)

SecondaryChange 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.

Time frame:: From baseline to 3 months
Reported as:: Median · pg/mL

Change in sTNF-R2 From 0 to 3 Months.
pg/mL	No Vitamin D	1000 IU of Vitamin D	2000 IU of Vitamin D	4000 IU of Vitamin D
Change in sTNF-R2 From 0 to 3 Months.	-0.89 (-187.75 to 160.10)	-9.88 (-130.28 to 149.19)	59.16 (-132.66 to 214.59)	13.29 (-137.03 to 144.32)

SecondaryChange 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.

Time frame:: From baseline to 3 months
Reported as:: Median · mg/L

Change in CRP From 0 to 3 Months.
mg/L	No Vitamin D	1000 IU of Vitamin D	2000 IU of Vitamin D	4000 IU of Vitamin D
Change in CRP From 0 to 3 Months.	-0.05 (-1.13 to 0.98)	0.07 (-0.58 to 0.86)	0.02 (-0.68 to 1.21)	0.03 (-0.68 to 0.79)

Adverse events

Collected over Every 2 weeks, up to 6 months.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
No Vitamin D	—	0/81 (0%)	0/29 (0%)
1000 IU of Vitamin D	—	0/81 (0%)	3/28 (10.7%)
2000 IU of Vitamin D	—	0/83 (0%)	1/31 (3.2%)
4000 IU of Vitamin D	—	0/83 (0%)	1/31 (3.2%)

Most frequent other events

Most frequent other events
Event	No Vitamin D	1000 IU of Vitamin D	2000 IU of Vitamin D	4000 IU of Vitamin D
hypercalcemia at 1 monthMetabolism and nutrition disorders	0/22	3/23	1/16	0/18
hypercalcemia at 3 monthsMetabolism and nutrition disorders	0/29	0/28	0/31	1/31

Baseline characteristics

Participants were 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.

Age, Continuous
Age, Continuous(years)	No Vitamin D	1000 IU of Vitamin D	2000 IU of Vitamin D	4000 IU of Vitamin D	Total
Median	50.7 (44.2 to 58.0)	51.1 (43.4 to 60.1)	50.3 (43.4 to 58.2)	51.3 (44.1 to 59.7)	51.0 (43.6 to 59.4)

Sex: Female, Male
Sex: Female, Male(Participants)	No Vitamin D	1000 IU of Vitamin D	2000 IU of Vitamin D	4000 IU of Vitamin D	Total
Female	54	59	55	54	222
Male	27	22	28	29	106

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	No Vitamin D	1000 IU of Vitamin D	2000 IU of Vitamin D	4000 IU of Vitamin D	Total
American Indian or Alaska Native	0	0	0	0	0
Asian	0	0	0	0	0
Native Hawaiian or Other Pacific Islander	0	0	0	0	0
Black or African American	81	81	83	83	328
White	0	0	0	0	0
More than one race	0	0	0	0	0
Unknown or Not Reported	0	0	0	0	0

Region of Enrollment
Region of Enrollment(participants)	No Vitamin D	1000 IU of Vitamin D	2000 IU of Vitamin D	4000 IU of Vitamin D	Total
United States	81	81	83	83	328

Study locations

1 site

Dana-Farber Cancer Institute
Boston, Massachusetts 02115, United States

References and documents

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 24657333 ↗
Ng 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 24368437 ↗
Chandler 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 24327720 ↗
Chandler 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 26858840 ↗
Chandler 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 24974387 ↗
Forman 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 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Apr 1, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00585637
Lead sponsor: Dana-Farber Cancer Institute
Collaborators: Harvard School of Public Health (HSPH)
Responsible party: Kimmie Ng, MD (Principal Investigator, Dana-Farber Cancer Institute) — Principal investigator
First posted: Jan 3, 2008
Start date: Oct 2007
Primary completion: Oct 2010
Completion: Dec 2013
Results posted: Apr 1, 2015
Last update: Apr 1, 2015

Study contacts

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

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

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