NCT00585637

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
328

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Oct 2007

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 24, 2007

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 3, 2008

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
3.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

April 1, 2015

Completed
Last Updated

April 1, 2015

Status Verified

March 1, 2015

Enrollment Period

3 years

First QC Date

December 24, 2007

Results QC Date

March 3, 2015

Last Update Submit

March 18, 2015

Conditions

Gastrointestinal CancersProstate CancerHypertension

Keywords

Vitamin DBlackscancerhypertension

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline, 3months, 6months

Secondary Outcomes (4)

  • Change in IL-6 From 0 to 3 Months.

    From baseline to 3 months

  • Change in IL-10 From 0 to 3 Months.

    From baseline to 3 months

  • Change in sTNF-R2 From 0 to 3 Months.

    From baseline to 3 months

  • Change in CRP From 0 to 3 Months.

    From baseline to 3 months

Study Arms (4)

1

ACTIVE COMPARATOR

No Vitamin D

Dietary Supplement: Placebo

2

ACTIVE COMPARATOR

1000 IU of Vitamin D

Drug: Vitamin D

3

ACTIVE COMPARATOR

2000 IU of Vitamin D

Drug: Vitamin D

4

ACTIVE COMPARATOR

4000 IU of Vitamin D

Drug: Vitamin D

Interventions

Vitamin DDRUG

Taken orally every day for three months

234
PlaceboDIETARY_SUPPLEMENT

Placebo pill taken once daily for 3 month

1

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Related Publications (6)

  • 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.

    PMID: 24657333RESULT

  • 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.

    PMID: 24368437RESULT

  • 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.

    PMID: 24327720RESULT

  • 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.

    PMID: 26858840DERIVED

  • 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.

    PMID: 24974387DERIVED

  • 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.

    PMID: 23487599DERIVED

MeSH Terms

Conditions

Gastrointestinal NeoplasmsProstatic NeoplasmsHypertensionNeoplasms

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesGastrointestinal DiseasesGenital Neoplasms, MaleUrogenital NeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

SecosteroidsSteroidsFused-Ring CompoundsPolycyclic Compounds

Results Point of Contact

Title
Kimmie Ng, MD, MPH
Organization
Dana-Farber Cancer Institute
Kimmie_Ng@dfci.harvard.edu
617-632-4150

Study Officials

  • Edward Giovannucci, MD, ScD

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

    PRINCIPAL INVESTIGATOR

  • Gary G Bennett, PhD

    Dana-Farber Cancer Institute

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 24, 2007

First Posted

January 3, 2008

Study Start

October 1, 2007

Primary Completion

October 1, 2010

Study Completion

December 1, 2013

Last Updated

April 1, 2015

Results First Posted

April 1, 2015

Record last verified: 2015-03

Locations

US(1)