Trial Outcomes & Findings for Pharmacokinetics of Vitamin D in Multiple Sclerosis and in Health (NCT NCT01667796)
NCT ID: NCT01667796
Last Updated: 2019-03-05
Results Overview
Generalized estimating equations (GEE) with an autoregressive with lag one correlation matrix were used to compare the serially-measured serum 25(OH)D levels between MS patients and Healthy Controls (HCs) to take into account repeated measures and within-subject correlations.
COMPLETED
NA
57 participants
Baseline to 90 days
2019-03-05
Participant Flow
Participant milestones
| Measure |
Multiple Sclerosis (MS) Subjects
MS patients
|
Healthy Controls
Healthy control subjects
|
|---|---|---|
|
Overall Study
STARTED
|
27
|
30
|
|
Overall Study
COMPLETED
|
24
|
29
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pharmacokinetics of Vitamin D in Multiple Sclerosis and in Health
Baseline characteristics by cohort
| Measure |
MS Subjects
n=27 Participants
Female subjects with MS
|
Healthy Controls
n=30 Participants
Female subjects without MS
|
Total
n=57 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
40.2 years
STANDARD_DEVIATION 9.2 • n=99 Participants
|
37.9 years
STANDARD_DEVIATION 12.1 • n=107 Participants
|
38.9 years
STANDARD_DEVIATION 10.8 • n=206 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
57 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
57 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
27 participants
n=99 Participants
|
30 participants
n=107 Participants
|
57 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline to 90 daysGeneralized estimating equations (GEE) with an autoregressive with lag one correlation matrix were used to compare the serially-measured serum 25(OH)D levels between MS patients and Healthy Controls (HCs) to take into account repeated measures and within-subject correlations.
Outcome measures
| Measure |
MS Subjects
n=24 Participants
Female subjects with MS
|
Healthy Controls
n=29 Participants
Female subjects without MS
|
|---|---|---|
|
Change in Mean Serum Level of 25-hydroxyvitamin D
|
65.9 nmol/L
Standard Deviation 5.9
|
82.4 nmol/L
Standard Deviation 5.2
|
SECONDARY outcome
Timeframe: Baseline, 90 daysAnalyzed the mean percentage change in IFNγ+ and IL-17+ cluster of differentiation 4 (CD4) + cells (post- versus pre- supplementation). This represents a change between two time points (90 days versus baseline).
Outcome measures
| Measure |
MS Subjects
n=11 Participants
Female subjects with MS
|
Healthy Controls
n=14 Participants
Female subjects without MS
|
|---|---|---|
|
Change in Percentages of T Cell Subsets (IFNγ+ and IL-17+)
mean percentage change in IFNγ+ CD4+ cells
|
-5.2 percentage of cells
Standard Deviation 4.2
|
-13.2 percentage of cells
Standard Deviation 3.2
|
|
Change in Percentages of T Cell Subsets (IFNγ+ and IL-17+)
mean percentage change in IL-17+ CD4+ cells
|
0.21 percentage of cells
Standard Deviation 0.77
|
-0.17 percentage of cells
Standard Deviation 1.14
|
SECONDARY outcome
Timeframe: 90 daysPopulation: We had initially planned to do whole blood gene expression. The experience gained by the laboratory that was to perform this since the original trial was planned was that this measure is too noisy and would not yield meaningful results. Thus, this analysis will no longer be conducted.
We had initially planned to do whole blood gene expression. The experience gained by the laboratory that was to perform this since the original trial was planned was that this measure is too noisy and would not yield meaningful results. Thus, this analysis will no longer be conducted.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 90 daysPopulation: Cytokine levels data were not analyzed and are no longer planned to be measured as outcomes.
The original plan had been to measure the change in basic serum cytokine levels (e.g. IL-17, interferon gamma; IL-10; pg/microliter). However, due to emerging data suggesting low utility of these measures, this plan was abandoned.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 90 daysPopulation: B Cell data were not analyzed and are no longer planned to be measured as outcomes.
The change in percentage (day 90-baseline) was originally planned for study. Due to the limited number of patients with samples this plan was abandoned.
Outcome measures
Outcome data not reported
Adverse Events
MS Subjects
Healthy Controls
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
MS Subjects
n=27 participants at risk
MS patients
|
Healthy Controls
n=30 participants at risk
Healthy control subjects
|
|---|---|---|
|
Cardiac disorders
Palpitations
|
0.00%
0/27
|
3.3%
1/30
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place