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Vitamin D for Chemoprevention

Primary Purpose

Gastrointestinal Cancers, Prostate Cancer, Hypertension

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Vitamin D

Placebo

About this trial

This is an interventional prevention trial for Gastrointestinal Cancers focused on measuring Vitamin D, Blacks, cancer, hypertension

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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:

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

Sites / Locations

Dana-Farber Cancer Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Arm Label

Arm Description

No Vitamin D

1000 IU of Vitamin D

2000 IU of Vitamin D

4000 IU of Vitamin D

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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.

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.

Full Information

NCT ID

NCT00585637

First Posted

December 24, 2007

Last Updated

March 18, 2015

Sponsor

Dana-Farber Cancer Institute

Collaborators

Harvard School of Public Health (HSPH)

1. Study Identification

Unique Protocol Identification Number

NCT00585637

Brief Title

Vitamin D for Chemoprevention

Official Title

Defining Optimal Doses of Vitamin D for Chemoprevention in Blacks.

Study Type

Interventional

2. Study Status

Record Verification Date

March 2015

Overall Recruitment Status

Completed

Study Start Date

October 2007 (undefined)

Primary Completion Date

October 2010 (Actual)

Study Completion Date

December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Dana-Farber Cancer Institute

Collaborators

Harvard School of Public Health (HSPH)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastrointestinal Cancers, Prostate Cancer, Hypertension

Keywords

Vitamin D, Blacks, cancer, hypertension

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

328 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

No Vitamin D

Arm Title

Arm Type

Active Comparator

Arm Description

1000 IU of Vitamin D

Arm Title

Arm Type

Active Comparator

Arm Description

2000 IU of Vitamin D

Arm Title

Arm Type

Active Comparator

Arm Description

4000 IU of Vitamin D

Intervention Type

Drug

Intervention Name(s)

Vitamin D

Intervention Description

Taken orally every day for three months

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo

Intervention Description

Placebo pill taken once daily for 3 month

Primary Outcome Measure Information:

Title

Levels of Plasma 25(OH)D at Baseline, 3 Months and 6 Months.

Description

Time Frame

Baseline, 3months, 6months

Secondary Outcome Measure Information:

Title

Change in IL-6 From 0 to 3 Months.

Description

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

Title

Change in IL-10 From 0 to 3 Months.

Description

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

Title

Change in sTNF-R2 From 0 to 3 Months.

Description

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

Title

Change in CRP From 0 to 3 Months.

Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Edward Giovannucci, MD, ScD

Organizational Affiliation

Harvard School of Public Health/Brigham and Women's Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Gary G Bennett, PhD

Organizational Affiliation

Dana-Farber Cancer Institute

Official's Role

Study Director

Facility Information:

Facility Name

Dana-Farber Cancer Institute

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

24657333

Citation

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.

Results Reference

result

PubMed Identifier

24368437

Citation

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.

Results Reference

result

PubMed Identifier

24327720

Citation

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.

Results Reference

result

PubMed Identifier

26858840

Citation

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.

Results Reference

derived

PubMed Identifier

24974387

Citation

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.

Results Reference

derived

PubMed Identifier

23487599

Citation

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.

Results Reference

derived

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Vitamin D for Chemoprevention

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