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Trial record 19 of 123 for:    hypertension "vitamin d"

Vitamin D for Chemoprevention

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ClinicalTrials.gov Identifier: NCT00585637
Recruitment Status : Completed
First Posted : January 3, 2008
Results First Posted : April 1, 2015
Last Update Posted : April 1, 2015
Sponsor:
Collaborator:
Harvard School of Public Health
Information provided by (Responsible Party):
Kimmie Ng, MD, Dana-Farber Cancer Institute

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions Gastrointestinal Cancers
Prostate Cancer
Hypertension
Interventions Drug: Vitamin D
Dietary Supplement: Placebo
Enrollment 328
Recruitment Details 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.
Pre-assignment Details  
Arm/Group Title No Vitamin D 1000 IU of Vitamin D 2000 IU of Vitamin D 4000 IU of Vitamin D
Hide Arm/Group Description

No Vitamin D

Placebo: Placebo pill taken once daily for 3 month

1000 IU of Vitamin D

Vitamin D: Taken orally every day for three months

2000 IU of Vitamin D

Vitamin D: Taken orally every day for three months

4000 IU of Vitamin D

Vitamin D: Taken orally every day for three months

Period Title: Baseline
Started 81 81 83 83
Completed 81 81 83 83
Not Completed 0 0 0 0
Period Title: 3-month Time Point
Started 81 81 83 83
Completed 71 67 76 78
Not Completed 10 14 7 5
Period Title: 6-month Time Point
Started 81 81 83 83
Completed 75 68 72 77
Not Completed 6 13 11 6
Arm/Group Title No Vitamin D 1000 IU of Vitamin D 2000 IU of Vitamin D 4000 IU of Vitamin D Total
Hide Arm/Group Description

No Vitamin D

Placebo: Placebo pill taken once daily for 3 month

1000 IU of Vitamin D

Vitamin D: Taken orally every day for three months

2000 IU of Vitamin D

Vitamin D: Taken orally every day for three months

4000 IU of Vitamin D

Vitamin D: Taken orally every day for three months

Total of all reporting groups
Overall Number of Baseline Participants 81 81 83 83 328
Hide Baseline Analysis Population Description
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  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 81 participants 81 participants 83 participants 83 participants 328 participants
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  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 81 participants 81 participants 83 participants 83 participants 328 participants
Female
54
  66.7%
59
  72.8%
55
  66.3%
54
  65.1%
222
  67.7%
Male
27
  33.3%
22
  27.2%
28
  33.7%
29
  34.9%
106
  32.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 81 participants 81 participants 83 participants 83 participants 328 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
81
 100.0%
81
 100.0%
83
 100.0%
83
 100.0%
328
 100.0%
White
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 81 participants 81 participants 83 participants 83 participants 328 participants
81 81 83 83 328
1.Primary Outcome
Title Levels of Plasma 25(OH)D at Baseline, 3 Months and 6 Months.
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants analyzed above is for baseline. At 3 months, number of participants analyzed was: 71 (no vitamin D), 67 (1000 IU Vitamin D), 76 (2000 IU Vitamin D) and 78 (4000 IU Vitamin D). At 6 months, number of participants analyzed was: 75 (no vitamin D), 68 (1000 IU Vitamin D), 72 (2000 IU Vitamin D) and 77 (4000 IU Vitamin D).
Arm/Group Title No Vitamin D 1000 IU of Vitamin D 2000 IU of Vitamin D 4000 IU of Vitamin D
Hide Arm/Group Description:

No Vitamin D

Placebo: Placebo pill taken once daily for 3 month

1000 IU of Vitamin D

Vitamin D: Taken orally every day for three months

2000 IU of Vitamin D

Vitamin D: Taken orally every day for three months

4000 IU of Vitamin D

Vitamin D: Taken orally every day for three months

Overall Number of Participants Analyzed 81 81 83 83
Median (Inter-Quartile Range)
Unit of Measure: ng/mL
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)
2.Secondary Outcome
Title Change in IL-6 From 0 to 3 Months.
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title No Vitamin D 1000 IU of Vitamin D 2000 IU of Vitamin D 4000 IU of Vitamin D
Hide Arm/Group Description:

No Vitamin D

Placebo: Placebo pill taken once daily for 3 month

1000 IU of Vitamin D

Vitamin D: Taken orally every day for three months

2000 IU of Vitamin D

Vitamin D: Taken orally every day for three months

4000 IU of Vitamin D

Vitamin D: Taken orally every day for three months

Overall Number of Participants Analyzed 71 67 76 78
Median (Inter-Quartile Range)
Unit of Measure: pg/mL
-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)
3.Secondary Outcome
Title Change in IL-10 From 0 to 3 Months.
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title No Vitamin D 1000 IU of Vitamin D 2000 IU of Vitamin D 4000 IU of Vitamin D
Hide Arm/Group Description:

No Vitamin D

Placebo: Placebo pill taken once daily for 3 month

1000 IU of Vitamin D

Vitamin D: Taken orally every day for three months

2000 IU of Vitamin D

Vitamin D: Taken orally every day for three months

4000 IU of Vitamin D

Vitamin D: Taken orally every day for three months

Overall Number of Participants Analyzed 71 67 76 78
Median (Inter-Quartile Range)
Unit of Measure: pg/mL
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)
4.Secondary Outcome
Title Change in sTNF-R2 From 0 to 3 Months.
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title No Vitamin D 1000 IU of Vitamin D 2000 IU of Vitamin D 4000 IU of Vitamin D
Hide Arm/Group Description:

No Vitamin D

Placebo: Placebo pill taken once daily for 3 month

1000 IU of Vitamin D

Vitamin D: Taken orally every day for three months

2000 IU of Vitamin D

Vitamin D: Taken orally every day for three months

4000 IU of Vitamin D

Vitamin D: Taken orally every day for three months

Overall Number of Participants Analyzed 71 67 76 78
Median (Inter-Quartile Range)
Unit of Measure: pg/mL
-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)
5.Secondary Outcome
Title Change in CRP From 0 to 3 Months.
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title No Vitamin D 1000 IU of Vitamin D 2000 IU of Vitamin D 4000 IU of Vitamin D
Hide Arm/Group Description:

No Vitamin D

Placebo: Placebo pill taken once daily for 3 month

1000 IU of Vitamin D

Vitamin D: Taken orally every day for three months

2000 IU of Vitamin D

Vitamin D: Taken orally every day for three months

4000 IU of Vitamin D

Vitamin D: Taken orally every day for three months

Overall Number of Participants Analyzed 71 67 76 78
Median (Inter-Quartile Range)
Unit of Measure: mg/L
-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)
Time Frame Every 2 weeks, up to 6 months.
Adverse Event Reporting Description Participants were assessed every 2 weeks. The table for 'Other (Non-Serious) Adverse Events' only reports on a subset of patients as calcium levels were only checked in a subset of patients. Although all patients were evaluated for adverse events, the only reported adverse event was hypercalcemia.
 
Arm/Group Title No Vitamin D 1000 IU of Vitamin D 2000 IU of Vitamin D 4000 IU of Vitamin D
Hide Arm/Group Description

No Vitamin D

Placebo: Placebo pill taken once daily for 3 month

1000 IU of Vitamin D

Vitamin D: Taken orally every day for three months

2000 IU of Vitamin D

Vitamin D: Taken orally every day for three months

4000 IU of Vitamin D

Vitamin D: Taken orally every day for three months

All-Cause Mortality
No Vitamin D 1000 IU of Vitamin D 2000 IU of Vitamin D 4000 IU of Vitamin D
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
No Vitamin D 1000 IU of Vitamin D 2000 IU of Vitamin D 4000 IU of Vitamin D
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/81 (0.00%)      0/81 (0.00%)      0/83 (0.00%)      0/83 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
No Vitamin D 1000 IU of Vitamin D 2000 IU of Vitamin D 4000 IU of Vitamin D
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/29 (0.00%)      3/28 (10.71%)      1/31 (3.23%)      1/31 (3.23%)    
Metabolism and nutrition disorders         
hypercalcemia at 1 month  0/22 (0.00%)  0 3/23 (13.04%)  3 1/16 (6.25%)  1 0/18 (0.00%)  0
hypercalcemia at 3 months  0/29 (0.00%)  0 0/28 (0.00%)  0 0/31 (0.00%)  0 1/31 (3.23%)  1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Kimmie Ng, MD, MPH
Organization: Dana-Farber Cancer Institute
Phone: 617-632-4150
Responsible Party: Kimmie Ng, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00585637     History of Changes
Other Study ID Numbers: 07-342
P15192 ( Other Identifier: Harvard School of Public Health )
First Submitted: December 24, 2007
First Posted: January 3, 2008
Results First Submitted: March 3, 2015
Results First Posted: April 1, 2015
Last Update Posted: April 1, 2015