Trial Outcomes & Findings for Improving Vitamin D Status In Cystic Fibrosis (NCT NCT00450073)
NCT ID: NCT00450073
Last Updated: 2014-02-21
Results Overview
This is a marker of vitamin D status
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
30 participants
Primary outcome timeframe
12 weeks
Results posted on
2014-02-21
Participant Flow
Please see full manuscript
Please see full manuscript
Participant milestones
| Measure |
Vitamin D3
vitamin D3 50,000 IU weekly
|
Vitamin D2
vitamin D2 50,000 IU weekly
|
Sunlamp
Use of a sunlamp 5 times a week for 12 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
10
|
|
Overall Study
COMPLETED
|
9
|
10
|
9
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Improving Vitamin D Status In Cystic Fibrosis
Baseline characteristics by cohort
| Measure |
Vitamin D3
n=10 Participants
vitamin D3 50,000 IU weekly
|
Vitamin D2
n=10 Participants
vitamin D2 50,000 IU weekly
|
Sunlamp
n=10 Participants
Use of a sunlamp 5 times a week for 12 weeks
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
30 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Continuous
|
35.7 years
STANDARD_DEVIATION 12.5 • n=99 Participants
|
27.9 years
STANDARD_DEVIATION 11.9 • n=107 Participants
|
33.3 years
STANDARD_DEVIATION 15.7 • n=206 Participants
|
32.1 years
STANDARD_DEVIATION 10 • n=7 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
16 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
14 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=99 Participants
|
10 participants
n=107 Participants
|
10 participants
n=206 Participants
|
30 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: 12 weeksThis is a marker of vitamin D status
Outcome measures
| Measure |
Vitamin D3
n=9 Participants
vitamin D3 50,000 IU weekly
|
Vitamin D2
n=10 Participants
vitamin D2 50,000 IU weekly
|
Sunlamp
n=9 Participants
Weekly use of a sunlamp
|
|---|---|---|---|
|
25-hydroxyvitamin D
|
21.2 ng/mL
Standard Deviation 10.3
|
24.4 ng/mL
Standard Deviation 10.2
|
28.2 ng/mL
Standard Deviation 3.2
|
SECONDARY outcome
Timeframe: 12 weeksOutcome measures
Outcome data not reported
Adverse Events
Vitamin D3
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Vitamin D2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sunlamp
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place