Trial Outcomes & Findings for Studies With 1,25-Dihydroxycholecalciferol (NCT NCT00001151)
NCT ID: NCT00001151
Last Updated: 2013-11-25
Results Overview
Normal calcium concentration 8.2-10.6 mg/dL
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
6 participants
Primary outcome timeframe
1 year average
Results posted on
2013-11-25
Participant Flow
Participant milestones
| Measure |
Group 1
Patient has rickets (child) or osteomalacia (adult) of bone
|
|---|---|
|
Overall Study
STARTED
|
6
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Studies With 1,25-Dihydroxycholecalciferol
Baseline characteristics by cohort
| Measure |
Group 1
n=6 Participants
Patient has rickets (cild) or osteomalacia (adult) of bone
|
|---|---|
|
Age, Continuous
|
15 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 year averageNormal calcium concentration 8.2-10.6 mg/dL
Outcome measures
| Measure |
Group 1
n=6 Participants
Patient has rickets (cild) or osteomalacia (adult) of bone
|
|---|---|
|
Number of Participants With Normal Serum Calcium Concentrations
|
6 participants
Interval 8.0 to 11.0
|
Adverse Events
Group 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Stephen J. Marx, M.D./National Institute of Diabetes and Digestive and Kidney Diseases
NIH
Phone: 3014965051
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place