Trial Outcomes & Findings for Effect of Vitamin D Supplement on Inflammation Markers in High-Risk Cardiovascular Patients With Chronic Kidney Disease (NCT NCT01012414)
NCT ID: NCT01012414
Last Updated: 2014-05-20
Results Overview
TERMINATED
PHASE3
10 participants
1 year
2014-05-20
Participant Flow
The enrollment period began in November 2009. The first subject was emrolled June 17, 2010. The final subject (#12) was enrolled April 14, 2011.
2 additional participants were in a washout period when the study was stopped. These participants were not enrolled or randomized.
Participant milestones
| Measure |
All Participants
The participants could have been randomized to one of the 2 arms; study drug or placebo. The study was never unblinded before termination.
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
10
|
Reasons for withdrawal
| Measure |
All Participants
The participants could have been randomized to one of the 2 arms; study drug or placebo. The study was never unblinded before termination.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Trial was stopped before completed
|
7
|
Baseline Characteristics
Effect of Vitamin D Supplement on Inflammation Markers in High-Risk Cardiovascular Patients With Chronic Kidney Disease
Baseline characteristics by cohort
| Measure |
Enrolled
n=10 Participants
Total number participants consentedand enrolled
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: Data were not collected when study was stopped prematurely.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 yearPopulation: Data were not collected when study was stopped prematurely.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 yearPopulation: Data were not collected when study was stopped prematurely.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 yearPopulation: Data were not collected when study was stopped prematurely.
Outcome measures
Outcome data not reported
Adverse Events
All Participants
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
All Participants
n=10 participants at risk
All participants in the study.
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Left rotator cuff surgery
|
10.0%
1/10 • Number of events 1 • 10 months
|
|
Surgical and medical procedures
bilateral cataract surgery
|
10.0%
1/10 • Number of events 1 • 10 months
|
|
Musculoskeletal and connective tissue disorders
Cramping in left hand
|
10.0%
1/10 • Number of events 1 • 10 months
|
|
General disorders
Muscles cramp, fever, hypotension,
|
10.0%
1/10 • Number of events 2 • 10 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place