Trial Outcomes & Findings for High Dose Vitamin D for Sickle Cell Disease (NCT NCT01331148)
NCT ID: NCT01331148
Last Updated: 2022-08-09
Results Overview
Change in 25 (OH)D level in SCD patients with and without chronic pain between baseline and 6 months.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
46 participants
Primary outcome timeframe
Baseline and after 6 months of study participation
Results posted on
2022-08-09
Participant Flow
Participant milestones
| Measure |
Vitamin D Arm
10,000 IU per caplet, with vitamin D dose based on weight, ranging from 240,000 IU to 600,000 IU. Patients will receive calcium/vitamin D daily soft chew as well.
Vitamin D: 10,000 IU/caplet, patients receiving 240,000 IU to 600,000 IU cumulative Vitamin D dose based on weight.
|
Placebo Arm
placebo only, all patients will receive calcium/vitamin D chew
Placebo: placebo with daily calcium/Vitamin D soft chews
|
|---|---|---|
|
Overall Study
STARTED
|
23
|
23
|
|
Overall Study
COMPLETED
|
20
|
19
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
High Dose Vitamin D for Sickle Cell Disease
Baseline characteristics by cohort
| Measure |
Vitamin D
n=20 Participants
10,000 IU per caplet, with vitamin D dose based on weight, ranging from 240,000 IU to 600,000 IU. Patients will receive calcium/vitamin D daily soft chew as well.
Vitamin D: 10,000 IU/caplet, patients receiving 240,000 IU to 600,000 IU cumulative Vitamin D dose based on weight.
|
Placebo
n=19 Participants
placebo only, all patients will receive calcium/vitamin D chew
Placebo: placebo with daily calcium/Vitamin D soft chews
|
Total
n=39 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
12.9 years
STANDARD_DEVIATION 0.6 • n=5 Participants
|
13.2 years
STANDARD_DEVIATION 0.8 • n=7 Participants
|
13.2 years
STANDARD_DEVIATION 3.1 • n=5 Participants
|
|
Age, Categorical
<=18 years
|
20 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
16 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
20 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
39 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
|
|
30-d pain diary pre enrollment
|
7.7 Days with pain
STANDARD_DEVIATION 7.2 • n=5 Participants
|
10.1 Days with pain
STANDARD_DEVIATION 9.7 • n=7 Participants
|
8.6 Days with pain
STANDARD_DEVIATION 8.5 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and after 6 months of study participationPopulation: Data for this outcome is only for completed subjects.
Change in 25 (OH)D level in SCD patients with and without chronic pain between baseline and 6 months.
Outcome measures
| Measure |
Drug
n=20 Participants
Receieved Vitamin D3 supplementation and Calcium
|
Placebo
n=19 Participants
Received placebo plus calcium
|
|---|---|---|
|
25 (OH)D in Nmol/L Between Baseline and 6 Months
|
55.2 nmol/L
Interval 36.2 to 74.2
|
50.4 nmol/L
Interval 29.9 to 70.9
|
Adverse Events
Vitamin D
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
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
Ifeyinwa Osunkwo, MD, MPH, Principal Investigator
Carolinas Healthcare System
Phone: 980 442 5001
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place