Trial Outcomes & Findings for Vitamin D3 Treatment in Pediatric Systemic Lupus Erythematosus (NCT NCT01709474)
NCT ID: NCT01709474
Last Updated: 2015-12-17
Results Overview
No mechanistic analyses were performed due to recruitment feasibility issues.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
7 participants
Primary outcome timeframe
Baseline to Week 18
Results posted on
2015-12-17
Participant Flow
Participant milestones
| Measure |
Vitamin D3 6000 IU
Participants received an 18-week course of oral Vitamin D3 (cholecalciferol, 6,000 international units \[IU\] daily).
|
Vitamin D3 400 IU
Participants received an 18-week course of oral Vitamin D3 (cholecalciferol, 400 international units \[IU\] daily).
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
4
|
|
Overall Study
COMPLETED
|
3
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Vitamin D3 Treatment in Pediatric Systemic Lupus Erythematosus
Baseline characteristics by cohort
| Measure |
Vitamin D3 6000 IU
n=3 Participants
Participants received an 18-week course of oral Vitamin D3 (cholecalciferol, 6,000 international units \[IU\] daily).
|
Vitamin D3 400 IU
n=4 Participants
Participants received an 18-week course of oral Vitamin D3 (cholecalciferol, 400 international units \[IU\] daily).
|
Total
n=7 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
16.3 years
STANDARD_DEVIATION 3.8 • n=5 Participants
|
13.5 years
STANDARD_DEVIATION 0.6 • n=7 Participants
|
14.7 years
STANDARD_DEVIATION 2.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 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
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 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
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 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
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
4 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
25(OH)D at Screening
|
9.3 ng/mL
STANDARD_DEVIATION 3.9 • n=5 Participants
|
16.1 ng/mL
STANDARD_DEVIATION 2.5 • n=7 Participants
|
13.2 ng/mL
STANDARD_DEVIATION 4.6 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 18Population: Data were not collected and therefore no analyses could be performed.
No mechanistic analyses were performed due to recruitment feasibility issues.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline to 18 WeeksPopulation: Intent-to-treat
Adverse event grading based on National Cancer Institute- Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.0
Outcome measures
| Measure |
Vitamin D3 6000 IU
n=3 Participants
Participants received an 18-week course of oral Vitamin D3 (cholecalciferol, 6,000 international units \[IU\] daily).
|
Vitamin D3 400 IU
n=4 Participants
Participants received an 18-week course of oral Vitamin D3 (cholecalciferol, 400 international units \[IU\] daily).
|
|---|---|---|
|
Percentage of Subjects by Treatment Arm Experiencing Any Adverse Event (AE) ≥ Grade 3
|
0 Percentage of Participants
|
25 Percentage of Participants
|
Adverse Events
Vitamin D3 6000 IU
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Vitamin D3 400 IU
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Vitamin D3 6000 IU
n=3 participants at risk
Participants received an 18-week course of oral Vitamin D3 (cholecalciferol, 6,000 international units \[IU\] daily).
|
Vitamin D3 400 IU
n=4 participants at risk
Participants received an 18-week course of oral Vitamin D3 (cholecalciferol, 400 international units \[IU\] daily).
|
|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/3 • From the time of administration of the first dose of study drug until the participant completed study participation, an average of 18 weeks.
|
25.0%
1/4 • Number of events 1 • From the time of administration of the first dose of study drug until the participant completed study participation, an average of 18 weeks.
|
|
Infections and infestations
Upper respiratory tract infection
|
33.3%
1/3 • Number of events 1 • From the time of administration of the first dose of study drug until the participant completed study participation, an average of 18 weeks.
|
0.00%
0/4 • From the time of administration of the first dose of study drug until the participant completed study participation, an average of 18 weeks.
|
|
Renal and urinary disorders
Hypercalciuria
|
33.3%
1/3 • Number of events 1 • From the time of administration of the first dose of study drug until the participant completed study participation, an average of 18 weeks.
|
0.00%
0/4 • From the time of administration of the first dose of study drug until the participant completed study participation, an average of 18 weeks.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/3 • From the time of administration of the first dose of study drug until the participant completed study participation, an average of 18 weeks.
|
25.0%
1/4 • Number of events 1 • From the time of administration of the first dose of study drug until the participant completed study participation, an average of 18 weeks.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
33.3%
1/3 • Number of events 1 • From the time of administration of the first dose of study drug until the participant completed study participation, an average of 18 weeks.
|
25.0%
1/4 • Number of events 1 • From the time of administration of the first dose of study drug until the participant completed study participation, an average of 18 weeks.
|
Additional Information
Director, Clinical Research Operations Program
DAIT/NIAID
Phone: 301-594-7669
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place