Trial Outcomes & Findings for Study of Vitamin D in Children With Sickle Cell Disease (NCT NCT01276587)
NCT ID: NCT01276587
Last Updated: 2023-04-12
Results Overview
Serum 25-hydroxyvitamin D level was measured at 6 months.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
4 participants
Primary outcome timeframe
Up to 6 months
Results posted on
2023-04-12
Participant Flow
Participant milestones
| Measure |
Single Arm
Vitamin D3: Oral vitamin D3 100,000 IU administered monthly for six months in children and adolescents with sickle cell disease
|
|---|---|
|
Overall Study
STARTED
|
4
|
|
Overall Study
COMPLETED
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Vitamin D in Children With Sickle Cell Disease
Baseline characteristics by cohort
| Measure |
Single Arm
n=4 Participants
Vitamin D3: Oral vitamin D3 100,000 IU administered monthly for six months in children and adolescents with sickle cell disease
|
|---|---|
|
Age, Categorical
<=18 years
|
4 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Serum 25-hydroxyvitamin D level
|
10.5 ng/mL
STANDARD_DEVIATION 2.6 • n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 6 monthsSerum 25-hydroxyvitamin D level was measured at 6 months.
Outcome measures
| Measure |
Single Arm
n=4 Participants
Vitamin D3: Oral vitamin D3 100,000 IU administered monthly for six months in children and adolescents with sickle cell disease
|
|---|---|
|
Serum 25-hydroxyvitamin D Concentration
Month 1
|
28.5 ng/mL
Standard Deviation 6.19
|
|
Serum 25-hydroxyvitamin D Concentration
Month 2
|
36.5 ng/mL
Standard Deviation 7.94
|
|
Serum 25-hydroxyvitamin D Concentration
Month 3
|
41.0 ng/mL
Standard Deviation 9.38
|
|
Serum 25-hydroxyvitamin D Concentration
Month 4
|
41.75 ng/mL
Standard Deviation 8.88
|
|
Serum 25-hydroxyvitamin D Concentration
Month 5
|
40.75 ng/mL
Standard Deviation 11.93
|
|
Serum 25-hydroxyvitamin D Concentration
Month 6
|
42.5 ng/mL
Standard Deviation 9.95
|
Adverse Events
Single Arm
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