Trial Outcomes & Findings for Vitamin D to Improve Endothelial Function in SLE (NCT NCT01911169)
NCT ID: NCT01911169
Last Updated: 2017-10-27
Results Overview
Measures were be performed with a Phillips iU22 Ultrasound system and a L9-3 9 mHz probe in 2D mode by a single operator using EKG gating. Baseline measures of brachial artery diameter will be made after the 10 minutes of rest. The blood pressure cuff, placed on the ipsilateral forearm, was inflated to 50 mmHg above the patient's systolic blood pressure for five minutes and then released. Endothelium-dependent FMD was measured continuously during and for three minutes after cuff release. Subjects rested for 10 minutes. Then, endothelium-independent dilation was measured 3 minutes after administration of 0.4 mg of sublingual nitroglycerine. The outcome (%FMD) was the difference between the average endothelium dependent diameter after cuff deflation and the average baseline diameter. The absolute difference between the % FMD at baseline and 16 week follow up was reported.
COMPLETED
PHASE2
9 participants
from zero to sixteen weeks
2017-10-27
Participant Flow
Initially, subjects will be recruited from the MUSC/UMA clinics. Once interest is confirmed by the subject, study personnel completed a chart review to determine if basic inclusion/exclusion criteria is met. If pre-screen criteria were met, a screening visit was scheduled where the informed consent process will be completed by PI/Sub-I.
72 SLE patients were identified with a low 25(OH)D level. Of these, 56 failed further pre-screening based on disease activity, medication use, and known cardiovascular disease. Of the 16 who underwent a screening visit, 7 patients failed to meet criteria for enrollment. Nine patients met inclusion and exclusion criteria and were randomized.
Participant milestones
| Measure |
Vitamin D 5000
5,000 IU vitamin D (cholecalciferol) given orally daily
Cholecalciferol: 5,000 International units versus 400 international units as an active comparator
|
Vitamin D 400
cholecalciferol 400 IU daily by mouth
Cholecalciferol: 5,000 International units versus 400 international units as an active comparator
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
3
|
|
Overall Study
COMPLETED
|
6
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Vitamin D to Improve Endothelial Function in SLE
Baseline characteristics by cohort
| Measure |
Vitamin D 5000
n=6 Participants
5,000 IU vitamin D (cholecalciferol) given orally daily
Cholecalciferol: 5,000 International units versus 400 international units as an active comparator
|
Vitamin D 400
n=3 Participants
cholecalciferol 400 IU daily by mouth
Cholecalciferol: 5,000 International units versus 400 international units as an active comparator
|
Total
n=9 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
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
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
|
0 Participants
n=7 Participants
|
0 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
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 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
|
PRIMARY outcome
Timeframe: from zero to sixteen weeksMeasures were be performed with a Phillips iU22 Ultrasound system and a L9-3 9 mHz probe in 2D mode by a single operator using EKG gating. Baseline measures of brachial artery diameter will be made after the 10 minutes of rest. The blood pressure cuff, placed on the ipsilateral forearm, was inflated to 50 mmHg above the patient's systolic blood pressure for five minutes and then released. Endothelium-dependent FMD was measured continuously during and for three minutes after cuff release. Subjects rested for 10 minutes. Then, endothelium-independent dilation was measured 3 minutes after administration of 0.4 mg of sublingual nitroglycerine. The outcome (%FMD) was the difference between the average endothelium dependent diameter after cuff deflation and the average baseline diameter. The absolute difference between the % FMD at baseline and 16 week follow up was reported.
Outcome measures
| Measure |
Repleted Vitamin D
n=6 Participants
Participants whose final serum 25(OH) vitamin D was \> 32 ng/ml after 16 weeks of oral vitamin D
|
Not Repleted Vitamin D
n=3 Participants
Participants whose vitamin D therapy failed to replete final serum levels to \> 32 ng/ml after 16 weeks of treatment
|
|---|---|---|
|
Change at Week 16 in % Flow Mediated Dilation in Those Who Did and Did Not Replete Vitamin D
|
1.4 Absolute change in % FMD
Standard Deviation 4.3
|
-4.2 Absolute change in % FMD
Standard Deviation 2.7
|
SECONDARY outcome
Timeframe: from zero to sixteen weeksThis outcome was not measured as planned
Outcome measures
Outcome data not reported
Adverse Events
Vitamin D 5000
Vitamin D 400
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Vitamin D 5000
n=6 participants at risk
5,000 IU vitamin D (cholecalciferol) given orally daily
Cholecalciferol: 5,000 International units versus 400 international units as an active comparator
|
Vitamin D 400
n=3 participants at risk
cholecalciferol 400 IU daily by mouth
Cholecalciferol: 5,000 International units versus 400 international units as an active comparator
|
|---|---|---|
|
Cardiac disorders
hypotension
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place