Trial Outcomes & Findings for Vitamin D for Chemoprevention (NCT NCT00585637)

Last Updated: 2015-04-01

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

328 participants

Primary outcome timeframe

Baseline, 3months, 6months

Results posted on

2015-04-01

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.

Participant milestones

Participant milestones
Measure	No Vitamin D No Vitamin D Placebo: Placebo pill taken once daily for 3 month	1000 IU of Vitamin D 1000 IU of Vitamin D Vitamin D: Taken orally every day for three months	2000 IU of Vitamin D 2000 IU of Vitamin D Vitamin D: Taken orally every day for three months	4000 IU of Vitamin D 4000 IU of Vitamin D Vitamin D: Taken orally every day for three months
Baseline STARTED	81	81	83	83
Baseline COMPLETED	81	81	83	83
Baseline NOT COMPLETED	0	0	0	0
3-month Time Point STARTED	81	81	83	83
3-month Time Point COMPLETED	71	67	76	78
3-month Time Point NOT COMPLETED	10	14	7	5
6-month Time Point STARTED	81	81	83	83
6-month Time Point COMPLETED	75	68	72	77
6-month Time Point NOT COMPLETED	6	13	11	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Vitamin D for Chemoprevention

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	No Vitamin D n=81 Participants No Vitamin D Placebo: Placebo pill taken once daily for 3 month	1000 IU of Vitamin D n=81 Participants 1000 IU of Vitamin D Vitamin D: Taken orally every day for three months	2000 IU of Vitamin D n=83 Participants 2000 IU of Vitamin D Vitamin D: Taken orally every day for three months	4000 IU of Vitamin D n=83 Participants 4000 IU of Vitamin D Vitamin D: Taken orally every day for three months	Total n=328 Participants Total of all reporting groups
Age, Continuous	50.7 years n=5 Participants	51.1 years n=7 Participants	50.3 years n=5 Participants	51.3 years n=4 Participants	51.0 years n=21 Participants
Sex: Female, Male Female	54 Participants n=5 Participants	59 Participants n=7 Participants	55 Participants n=5 Participants	54 Participants n=4 Participants	222 Participants n=21 Participants
Sex: Female, Male Male	27 Participants n=5 Participants	22 Participants n=7 Participants	28 Participants n=5 Participants	29 Participants n=4 Participants	106 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	81 Participants n=5 Participants	81 Participants n=7 Participants	83 Participants n=5 Participants	83 Participants n=4 Participants	328 Participants n=21 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Region of Enrollment United States	81 participants n=5 Participants	81 participants n=7 Participants	83 participants n=5 Participants	83 participants n=4 Participants	328 participants n=21 Participants

PRIMARY outcome

Timeframe: Baseline, 3months, 6months

Population: 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).

Outcome measures

Outcome measures
Measure	No Vitamin D n=81 Participants No Vitamin D Placebo: Placebo pill taken once daily for 3 month	1000 IU of Vitamin D n=81 Participants 1000 IU of Vitamin D Vitamin D: Taken orally every day for three months	2000 IU of Vitamin D n=83 Participants 2000 IU of Vitamin D Vitamin D: Taken orally every day for three months	4000 IU of Vitamin D n=83 Participants 4000 IU of Vitamin D Vitamin D: Taken orally every day for three months
Levels of Plasma 25(OH)D at Baseline, 3 Months and 6 Months. Baseline 25(OH)D	15.1 ng/mL Interval 10.4 to 23.6	16.2 ng/mL Interval 11.0 to 22.7	13.9 ng/mL Interval 9.5 to 22.3	15.7 ng/mL Interval 11.0 to 23.3
Levels of Plasma 25(OH)D at Baseline, 3 Months and 6 Months. 25(OH)D at 3 months	13.7 ng/mL Interval 7.2 to 18.6	29.7 ng/mL Interval 25.6 to 32.9	34.8 ng/mL Interval 28.8 to 41.0	45.9 ng/mL Interval 39.4 to 55.2
Levels of Plasma 25(OH)D at Baseline, 3 Months and 6 Months. 25(OH)D at 6 months	18.1 ng/mL Interval 12.2 to 23.3	21.2 ng/mL Interval 16.8 to 27.8	27.0 ng/mL Interval 20.6 to 31.1	31.2 ng/mL Interval 26.5 to 35.9

SECONDARY outcome

Timeframe: From baseline to 3 months

Population: 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.

Examine the influence of oral vitamin D supplementation on inflammatory marker IL-6 from baseline to the 3 month follow-up.

Outcome measures

Outcome measures
Measure	No Vitamin D n=71 Participants No Vitamin D Placebo: Placebo pill taken once daily for 3 month	1000 IU of Vitamin D n=67 Participants 1000 IU of Vitamin D Vitamin D: Taken orally every day for three months	2000 IU of Vitamin D n=76 Participants 2000 IU of Vitamin D Vitamin D: Taken orally every day for three months	4000 IU of Vitamin D n=78 Participants 4000 IU of Vitamin D Vitamin D: Taken orally every day for three months
Change in IL-6 From 0 to 3 Months.	-0.03 pg/mL Interval -0.96 to 0.88	-0.07 pg/mL Interval -1.07 to 0.93	0.01 pg/mL Interval -0.57 to 0.89	0.08 pg/mL Interval -0.61 to 0.71

SECONDARY outcome

Timeframe: From baseline to 3 months

Examine the influence of oral vitamin D supplementation on inflammatory marker IL-10 from baseline to the 3 month follow-up.

Outcome measures

Outcome measures
Measure	No Vitamin D n=71 Participants No Vitamin D Placebo: Placebo pill taken once daily for 3 month	1000 IU of Vitamin D n=67 Participants 1000 IU of Vitamin D Vitamin D: Taken orally every day for three months	2000 IU of Vitamin D n=76 Participants 2000 IU of Vitamin D Vitamin D: Taken orally every day for three months	4000 IU of Vitamin D n=78 Participants 4000 IU of Vitamin D Vitamin D: Taken orally every day for three months
Change in IL-10 From 0 to 3 Months.	0 pg/mL Interval -0.06 to 0.07	-0.01 pg/mL Interval -0.08 to 0.02	-0.02 pg/mL Interval -0.09 to 0.02	0.00 pg/mL Interval -0.06 to 0.04

SECONDARY outcome

Timeframe: From baseline to 3 months

Examine the influence of oral vitamin D supplementation on inflammatory marker sTNF-R2 from baseline to the 3 month follow-up.

Outcome measures

Outcome measures
Measure	No Vitamin D n=71 Participants No Vitamin D Placebo: Placebo pill taken once daily for 3 month	1000 IU of Vitamin D n=67 Participants 1000 IU of Vitamin D Vitamin D: Taken orally every day for three months	2000 IU of Vitamin D n=76 Participants 2000 IU of Vitamin D Vitamin D: Taken orally every day for three months	4000 IU of Vitamin D n=78 Participants 4000 IU of Vitamin D Vitamin D: Taken orally every day for three months
Change in sTNF-R2 From 0 to 3 Months.	-0.89 pg/mL Interval -187.75 to 160.1	-9.88 pg/mL Interval -130.28 to 149.19	59.16 pg/mL Interval -132.66 to 214.59	13.29 pg/mL Interval -137.03 to 144.32

SECONDARY outcome

Timeframe: From baseline to 3 months

Examine the influence of oral vitamin D supplementation on inflammatory marker CRP from baseline to the 3 month follow-up.

Outcome measures

Outcome measures
Measure	No Vitamin D n=71 Participants No Vitamin D Placebo: Placebo pill taken once daily for 3 month	1000 IU of Vitamin D n=67 Participants 1000 IU of Vitamin D Vitamin D: Taken orally every day for three months	2000 IU of Vitamin D n=76 Participants 2000 IU of Vitamin D Vitamin D: Taken orally every day for three months	4000 IU of Vitamin D n=78 Participants 4000 IU of Vitamin D Vitamin D: Taken orally every day for three months
Change in CRP From 0 to 3 Months.	-0.05 mg/L Interval -1.13 to 0.98	0.07 mg/L Interval -0.58 to 0.86	0.02 mg/L Interval -0.68 to 1.21	0.03 mg/L Interval -0.68 to 0.79

Adverse Events

No Vitamin D

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

1000 IU of Vitamin D

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

2000 IU of Vitamin D

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

4000 IU of Vitamin D

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	No Vitamin D n=29 participants at risk；n=81 participants at risk No Vitamin D Placebo: Placebo pill taken once daily for 3 month	1000 IU of Vitamin D n=28 participants at risk；n=81 participants at risk 1000 IU of Vitamin D Vitamin D: Taken orally every day for three months	2000 IU of Vitamin D n=31 participants at risk；n=83 participants at risk 2000 IU of Vitamin D Vitamin D: Taken orally every day for three months	4000 IU of Vitamin D n=31 participants at risk；n=83 participants at risk 4000 IU of Vitamin D Vitamin D: Taken orally every day for three months
Metabolism and nutrition disorders hypercalcemia at 1 month	0.00% 0/22 • Every 2 weeks, up to 6 months. 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.	13.0% 3/23 • Number of events 3 • Every 2 weeks, up to 6 months. 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.	6.2% 1/16 • Number of events 1 • Every 2 weeks, up to 6 months. 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.	0.00% 0/18 • Every 2 weeks, up to 6 months. 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.
Metabolism and nutrition disorders hypercalcemia at 3 months	0.00% 0/29 • Every 2 weeks, up to 6 months. 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.	0.00% 0/28 • Every 2 weeks, up to 6 months. 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.	0.00% 0/31 • Every 2 weeks, up to 6 months. 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.	3.2% 1/31 • Number of events 1 • Every 2 weeks, up to 6 months. 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.

Additional Information

Kimmie Ng, MD, MPH

Dana-Farber Cancer Institute

Phone: 617-632-4150

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60