Trial Outcomes & Findings for Randomized Controlled Trial of Vitamin D3 in Diabetic Kidney Disease (NCT NCT00552409)
NCT ID: NCT00552409
Last Updated: 2014-04-28
Results Overview
Albumin and creatinine concentrations were measured in 24hr urine collections at baseline, 3 months after randomization, and one year after randomization. We analyzed the difference in log-transformed albumin-creatinine ratio (ACR, mg/g) after randomization (3 months and one year, analyzed together with all available data included) compared with baseline, by treatment assignment. Results are transformed to present percent difference in urine ACR.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
22 participants
Primary outcome timeframe
Baseline, 3 months, and one year
Results posted on
2014-04-28
Participant Flow
Ninety-three participants from medical clinics associated from the University of Washington (Seattle, WA) provided informed consent for this study between February, 2008 through June, 2009.
Of the 93 participants who provided informed consent, 63 were ineligible, 8 withdrew prior to randomization, and 22 were randomized to treatment.
Participant milestones
| Measure |
Cholecalciferol
2000 IU by mouth daily for one year
|
Placebo
One softgel daily for one year
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
11
|
|
Overall Study
COMPLETED
|
10
|
9
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Randomized Controlled Trial of Vitamin D3 in Diabetic Kidney Disease
Baseline characteristics by cohort
| Measure |
Cholecalciferol
n=11 Participants
2000 IU by mouth daily for one year
|
Placebo
n=11 Participants
One softgel daily for one year
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Age, Continuous
|
60 years
STANDARD_DEVIATION 10 • n=5 Participants
|
61 years
STANDARD_DEVIATION 13 • n=7 Participants
|
60 years
STANDARD_DEVIATION 11 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=5 Participants
|
11 participants
n=7 Participants
|
22 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 3 months, and one yearPopulation: All participants were analyzed
Albumin and creatinine concentrations were measured in 24hr urine collections at baseline, 3 months after randomization, and one year after randomization. We analyzed the difference in log-transformed albumin-creatinine ratio (ACR, mg/g) after randomization (3 months and one year, analyzed together with all available data included) compared with baseline, by treatment assignment. Results are transformed to present percent difference in urine ACR.
Outcome measures
| Measure |
Cholecalciferol
n=11 Participants
2000 IU by mouth daily for one year
|
Placebo
n=11 Participants
One softgel daily for one year
|
|---|---|---|
|
Change in Urine Albumin Excretion
|
-21 percent difference
Interval -50.0 to 23.0
|
-5 percent difference
Interval -40.0 to 49.0
|
Adverse Events
Cholecalciferol
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cholecalciferol
n=11 participants at risk
2000 IU by mouth daily for one year
|
Placebo
n=11 participants at risk
One softgel daily for one year
|
|---|---|---|
|
Infections and infestations
sinus infection
|
0.00%
0/11
|
9.1%
1/11 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
carpal tunnel syndrome
|
0.00%
0/11
|
9.1%
1/11 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
frozen shoulder
|
0.00%
0/11
|
9.1%
1/11 • Number of events 1
|
|
General disorders
ovarian cyst
|
0.00%
0/11
|
9.1%
1/11 • Number of events 1
|
|
Infections and infestations
vaginitis
|
0.00%
0/11
|
9.1%
1/11 • Number of events 1
|
|
General disorders
sleep apnea
|
0.00%
0/11
|
9.1%
1/11 • Number of events 1
|
|
Infections and infestations
upper respiratory infection
|
18.2%
2/11 • Number of events 2
|
18.2%
2/11 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
toe amputation
|
0.00%
0/11
|
9.1%
1/11 • Number of events 1
|
|
Gastrointestinal disorders
diarrhea
|
0.00%
0/11
|
9.1%
1/11 • Number of events 1
|
|
Gastrointestinal disorders
fecal incontinence
|
0.00%
0/11
|
9.1%
1/11 • Number of events 1
|
|
General disorders
dizziness
|
0.00%
0/11
|
9.1%
1/11 • Number of events 1
|
|
Endocrine disorders
hyperglycemia
|
0.00%
0/11
|
9.1%
1/11 • Number of events 2
|
|
General disorders
edema
|
9.1%
1/11 • Number of events 2
|
9.1%
1/11 • Number of events 1
|
|
Cardiac disorders
elevated blood pressure
|
0.00%
0/11
|
9.1%
1/11 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
shoulder pain
|
0.00%
0/11
|
18.2%
2/11 • Number of events 4
|
|
Cardiac disorders
low blood pressure
|
0.00%
0/11
|
9.1%
1/11 • Number of events 1
|
|
General disorders
lack of energy
|
0.00%
0/11
|
9.1%
1/11 • Number of events 1
|
|
Psychiatric disorders
decreased mood
|
9.1%
1/11 • Number of events 1
|
9.1%
1/11 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
knee pain
|
0.00%
0/11
|
9.1%
1/11 • Number of events 1
|
|
Psychiatric disorders
anhedonia
|
0.00%
0/11
|
9.1%
1/11 • Number of events 1
|
|
Injury, poisoning and procedural complications
burned throat
|
0.00%
0/11
|
9.1%
1/11 • Number of events 1
|
|
General disorders
cough
|
27.3%
3/11 • Number of events 3
|
0.00%
0/11
|
|
Ear and labyrinth disorders
ear infection
|
9.1%
1/11 • Number of events 1
|
0.00%
0/11
|
|
General disorders
rash
|
18.2%
2/11 • Number of events 2
|
0.00%
0/11
|
|
General disorders
dyspnea
|
0.00%
0/11
|
9.1%
1/11 • Number of events 1
|
|
General disorders
abdominal swelling
|
9.1%
1/11 • Number of events 3
|
0.00%
0/11
|
|
Eye disorders
glaucoma
|
9.1%
1/11 • Number of events 1
|
0.00%
0/11
|
|
Immune system disorders
multiple sclerosis flair
|
9.1%
1/11 • Number of events 2
|
0.00%
0/11
|
|
Infections and infestations
cellulitis
|
9.1%
1/11 • Number of events 2
|
0.00%
0/11
|
|
General disorders
endovenous laser treatment
|
9.1%
1/11 • Number of events 1
|
0.00%
0/11
|
|
Musculoskeletal and connective tissue disorders
trigger finger
|
9.1%
1/11 • Number of events 1
|
0.00%
0/11
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place