Trial Outcomes & Findings for Vitamin D Levels in Children With IBD (NCT NCT00621257)
NCT ID: NCT00621257
Last Updated: 2017-03-22
Results Overview
Change in serum 25OHD levels after treatment with vitamin D formulations for 6 weeks in pediatric patients with inflammatory bowel disease. 25OHD is the most abundant vitamin D metabolite, which is bound to vitamin D binding protein. The measurement of its concentration in serum, reflects vitamin D stores.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
134 participants
Primary outcome timeframe
6 weeks
Results posted on
2017-03-22
Participant Flow
Participant milestones
| Measure |
Treatment A
2,000 IU/day of vitamin D2 orally for 6 weeks (control arm)
ergocalciferol: 8000 units/ml
|
Treatment B
2,000 IU/day of vitamin D3 orally for 6 weeks
Cholecalciferol: 400 units per drop
|
Treatment C
50,000 IU of vitamin D2 once a week orally for 6 weeks
ergocalciferol: 8000 units/ml
|
Maintenance A
400 IU/day of vitamin D2 orally over 2 years (control arm)
ergocalciferol: 8000 units/ml
|
Maintenance B
2,000 IU/day of vitamin D2 orally from November 1 to April 30, and 1,000 IU/day of vitamin D2 orally for the remainder of the year over 2 years
ergocalciferol: 8000 units/ml
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
24
|
24
|
23
|
32
|
31
|
|
Overall Study
COMPLETED
|
20
|
21
|
20
|
26
|
22
|
|
Overall Study
NOT COMPLETED
|
4
|
3
|
3
|
6
|
9
|
Reasons for withdrawal
| Measure |
Treatment A
2,000 IU/day of vitamin D2 orally for 6 weeks (control arm)
ergocalciferol: 8000 units/ml
|
Treatment B
2,000 IU/day of vitamin D3 orally for 6 weeks
Cholecalciferol: 400 units per drop
|
Treatment C
50,000 IU of vitamin D2 once a week orally for 6 weeks
ergocalciferol: 8000 units/ml
|
Maintenance A
400 IU/day of vitamin D2 orally over 2 years (control arm)
ergocalciferol: 8000 units/ml
|
Maintenance B
2,000 IU/day of vitamin D2 orally from November 1 to April 30, and 1,000 IU/day of vitamin D2 orally for the remainder of the year over 2 years
ergocalciferol: 8000 units/ml
|
|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
0
|
2
|
4
|
7
|
|
Overall Study
Adverse Event
|
0
|
1
|
1
|
0
|
0
|
|
Overall Study
Physician Decision
|
0
|
2
|
0
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
1
|
Baseline Characteristics
Vitamin D Levels in Children With IBD
Baseline characteristics by cohort
| Measure |
Treatment A
n=24 Participants
2,000 IU/day of vitamin D2 orally for 6 weeks (control arm)
ergocalciferol: 8000 units/ml
|
Treatment B
n=24 Participants
2,000 IU/day of vitamin D3 orally for 6 weeks
Cholecalciferol: 400 units per drop
|
Treatment C
n=23 Participants
50,000 IU of vitamin D2 once a week orally for 6 weeks
ergocalciferol: 8000 units/ml
|
Maintenance A
n=32 Participants
400 IU/day of vitamin D2 orally over 2 years (control arm)
ergocalciferol: 8000 units/ml
|
Maintenance B
n=31 Participants
2,000 IU/day of vitamin D2 orally from November 1 to April 30, and 1,000 IU/day of vitamin D2 orally for the remainder of the year over 2 years
ergocalciferol: 8000 units/ml
|
Total
n=134 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
15.9 years
STANDARD_DEVIATION 3 • n=5 Participants
|
14.7 years
STANDARD_DEVIATION 3.5 • n=7 Participants
|
16.3 years
STANDARD_DEVIATION 3.2 • n=5 Participants
|
15.1 years
STANDARD_DEVIATION 3.1 • n=4 Participants
|
14.5 years
STANDARD_DEVIATION 3.1 • n=21 Participants
|
15.2 years
STANDARD_DEVIATION 3.2 • n=10 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
69 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
65 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: 6 weeksChange in serum 25OHD levels after treatment with vitamin D formulations for 6 weeks in pediatric patients with inflammatory bowel disease. 25OHD is the most abundant vitamin D metabolite, which is bound to vitamin D binding protein. The measurement of its concentration in serum, reflects vitamin D stores.
Outcome measures
| Measure |
Treatment A
n=24 Participants
2,000 IU/day of vitamin D2 orally for 6 weeks (control arm)
ergocalciferol: 8000 units/ml
|
Treatment B
n=24 Participants
2,000 IU/day of vitamin D3 orally for 6 weeks
Cholecalciferol: 400 units per drop
|
Treatment C
n=23 Participants
50,000 IU of vitamin D2 once a week orally for 6 weeks
ergocalciferol: 8000 units/ml
|
|---|---|---|---|
|
Treatment of Low 25 Hydroxy Vitamin D Levels in Pediatric Patients With Inflammatory Bowel Disease
|
9.3 ng/ml
Standard Deviation 1.8
|
16.4 ng/ml
Standard Deviation 2.0
|
25.4 ng/ml
Standard Deviation 2.5
|
SECONDARY outcome
Timeframe: 12 monthsPercentage of pediatric patients with inflammatory bowel disease who maintained their serum 25OHD level at or above 32 ng/mL at all study visits over the duration of the maintenance study 25OHD is the most abundant vitamin D metabolite, which is bound to vitamin D binding protein. The measurement of its concentration in serum, reflects vitamin D stores. Concentration at or above 32 ng/mL has been identified as optimal vitamin D level for bone health by majority of experts.
Outcome measures
| Measure |
Treatment A
n=32 Participants
2,000 IU/day of vitamin D2 orally for 6 weeks (control arm)
ergocalciferol: 8000 units/ml
|
Treatment B
n=31 Participants
2,000 IU/day of vitamin D3 orally for 6 weeks
Cholecalciferol: 400 units per drop
|
Treatment C
50,000 IU of vitamin D2 once a week orally for 6 weeks
ergocalciferol: 8000 units/ml
|
|---|---|---|---|
|
Maintenance of 25 Hydroxy Vitamin D Levels in Pediatric Patients With Inflammatory Bowel Disease
|
3 Participants
|
3 Participants
|
—
|
Adverse Events
Treatment A
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Treatment B
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Treatment C
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Maintenance A
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Maintenance B
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment A
n=24 participants at risk
2,000 IU/day of vitamin D2 orally for 6 weeks (control arm)
ergocalciferol: 8000 units/ml
|
Treatment B
n=24 participants at risk
2,000 IU/day of vitamin D3 orally for 6 weeks
Cholecalciferol: 400 units per drop
|
Treatment C
n=23 participants at risk
50,000 IU of vitamin D2 once a week orally for 6 weeks
ergocalciferol: 8000 units/ml
|
Maintenance A
n=32 participants at risk
400 IU per day of oral vitamin D2
ergocalciferol 8000 IU/ml
|
Maintenance B
n=31 participants at risk
1,000 IU of oral vitamin D2 per day from May to October and 2,000 IU of oral vitamin D2 per day of oral vitamin D2 per day from November to April
ergocalciferol 8000 IU/ml
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/24 • 6 weeks while participant was on study medication for treatment trial
For 1 year, while participant was on study medication for the maintenance trial.
|
4.2%
1/24 • Number of events 1 • 6 weeks while participant was on study medication for treatment trial
For 1 year, while participant was on study medication for the maintenance trial.
|
4.3%
1/23 • Number of events 1 • 6 weeks while participant was on study medication for treatment trial
For 1 year, while participant was on study medication for the maintenance trial.
|
6.2%
2/32 • Number of events 2 • 6 weeks while participant was on study medication for treatment trial
For 1 year, while participant was on study medication for the maintenance trial.
|
12.9%
4/31 • Number of events 4 • 6 weeks while participant was on study medication for treatment trial
For 1 year, while participant was on study medication for the maintenance trial.
|
|
Nervous system disorders
Drowsiness
|
0.00%
0/24 • 6 weeks while participant was on study medication for treatment trial
For 1 year, while participant was on study medication for the maintenance trial.
|
0.00%
0/24 • 6 weeks while participant was on study medication for treatment trial
For 1 year, while participant was on study medication for the maintenance trial.
|
4.3%
1/23 • Number of events 1 • 6 weeks while participant was on study medication for treatment trial
For 1 year, while participant was on study medication for the maintenance trial.
|
12.5%
4/32 • Number of events 4 • 6 weeks while participant was on study medication for treatment trial
For 1 year, while participant was on study medication for the maintenance trial.
|
16.1%
5/31 • Number of events 5 • 6 weeks while participant was on study medication for treatment trial
For 1 year, while participant was on study medication for the maintenance trial.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
4.2%
1/24 • Number of events 1 • 6 weeks while participant was on study medication for treatment trial
For 1 year, while participant was on study medication for the maintenance trial.
|
0.00%
0/24 • 6 weeks while participant was on study medication for treatment trial
For 1 year, while participant was on study medication for the maintenance trial.
|
4.3%
1/23 • Number of events 1 • 6 weeks while participant was on study medication for treatment trial
For 1 year, while participant was on study medication for the maintenance trial.
|
9.4%
3/32 • Number of events 3 • 6 weeks while participant was on study medication for treatment trial
For 1 year, while participant was on study medication for the maintenance trial.
|
6.5%
2/31 • Number of events 2 • 6 weeks while participant was on study medication for treatment trial
For 1 year, while participant was on study medication for the maintenance trial.
|
|
Musculoskeletal and connective tissue disorders
Muscle pain
|
0.00%
0/24 • 6 weeks while participant was on study medication for treatment trial
For 1 year, while participant was on study medication for the maintenance trial.
|
0.00%
0/24 • 6 weeks while participant was on study medication for treatment trial
For 1 year, while participant was on study medication for the maintenance trial.
|
4.3%
1/23 • Number of events 1 • 6 weeks while participant was on study medication for treatment trial
For 1 year, while participant was on study medication for the maintenance trial.
|
9.4%
3/32 • Number of events 3 • 6 weeks while participant was on study medication for treatment trial
For 1 year, while participant was on study medication for the maintenance trial.
|
0.00%
0/31 • 6 weeks while participant was on study medication for treatment trial
For 1 year, while participant was on study medication for the maintenance trial.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/24 • 6 weeks while participant was on study medication for treatment trial
For 1 year, while participant was on study medication for the maintenance trial.
|
4.2%
1/24 • Number of events 1 • 6 weeks while participant was on study medication for treatment trial
For 1 year, while participant was on study medication for the maintenance trial.
|
0.00%
0/23 • 6 weeks while participant was on study medication for treatment trial
For 1 year, while participant was on study medication for the maintenance trial.
|
15.6%
5/32 • Number of events 5 • 6 weeks while participant was on study medication for treatment trial
For 1 year, while participant was on study medication for the maintenance trial.
|
9.7%
3/31 • Number of events 3 • 6 weeks while participant was on study medication for treatment trial
For 1 year, while participant was on study medication for the maintenance trial.
|
|
Nervous system disorders
headache
|
0.00%
0/24 • 6 weeks while participant was on study medication for treatment trial
For 1 year, while participant was on study medication for the maintenance trial.
|
4.2%
1/24 • Number of events 1 • 6 weeks while participant was on study medication for treatment trial
For 1 year, while participant was on study medication for the maintenance trial.
|
0.00%
0/23 • 6 weeks while participant was on study medication for treatment trial
For 1 year, while participant was on study medication for the maintenance trial.
|
15.6%
5/32 • Number of events 5 • 6 weeks while participant was on study medication for treatment trial
For 1 year, while participant was on study medication for the maintenance trial.
|
6.5%
2/31 • Number of events 2 • 6 weeks while participant was on study medication for treatment trial
For 1 year, while participant was on study medication for the maintenance trial.
|
|
Nervous system disorders
Increased thirst
|
4.2%
1/24 • Number of events 1 • 6 weeks while participant was on study medication for treatment trial
For 1 year, while participant was on study medication for the maintenance trial.
|
8.3%
2/24 • Number of events 2 • 6 weeks while participant was on study medication for treatment trial
For 1 year, while participant was on study medication for the maintenance trial.
|
4.3%
1/23 • Number of events 1 • 6 weeks while participant was on study medication for treatment trial
For 1 year, while participant was on study medication for the maintenance trial.
|
12.5%
4/32 • Number of events 4 • 6 weeks while participant was on study medication for treatment trial
For 1 year, while participant was on study medication for the maintenance trial.
|
16.1%
5/31 • Number of events 5 • 6 weeks while participant was on study medication for treatment trial
For 1 year, while participant was on study medication for the maintenance trial.
|
|
Renal and urinary disorders
Increased urination
|
0.00%
0/24 • 6 weeks while participant was on study medication for treatment trial
For 1 year, while participant was on study medication for the maintenance trial.
|
4.2%
1/24 • Number of events 1 • 6 weeks while participant was on study medication for treatment trial
For 1 year, while participant was on study medication for the maintenance trial.
|
4.3%
1/23 • Number of events 1 • 6 weeks while participant was on study medication for treatment trial
For 1 year, while participant was on study medication for the maintenance trial.
|
6.2%
2/32 • Number of events 2 • 6 weeks while participant was on study medication for treatment trial
For 1 year, while participant was on study medication for the maintenance trial.
|
3.2%
1/31 • Number of events 1 • 6 weeks while participant was on study medication for treatment trial
For 1 year, while participant was on study medication for the maintenance trial.
|
|
Skin and subcutaneous tissue disorders
itching skin
|
0.00%
0/24 • 6 weeks while participant was on study medication for treatment trial
For 1 year, while participant was on study medication for the maintenance trial.
|
8.3%
2/24 • Number of events 2 • 6 weeks while participant was on study medication for treatment trial
For 1 year, while participant was on study medication for the maintenance trial.
|
4.3%
1/23 • Number of events 1 • 6 weeks while participant was on study medication for treatment trial
For 1 year, while participant was on study medication for the maintenance trial.
|
6.2%
2/32 • Number of events 2 • 6 weeks while participant was on study medication for treatment trial
For 1 year, while participant was on study medication for the maintenance trial.
|
3.2%
1/31 • Number of events 1 • 6 weeks while participant was on study medication for treatment trial
For 1 year, while participant was on study medication for the maintenance trial.
|
|
Cardiac disorders
irregular heart beat
|
0.00%
0/24 • 6 weeks while participant was on study medication for treatment trial
For 1 year, while participant was on study medication for the maintenance trial.
|
0.00%
0/24 • 6 weeks while participant was on study medication for treatment trial
For 1 year, while participant was on study medication for the maintenance trial.
|
4.3%
1/23 • Number of events 1 • 6 weeks while participant was on study medication for treatment trial
For 1 year, while participant was on study medication for the maintenance trial.
|
0.00%
0/32 • 6 weeks while participant was on study medication for treatment trial
For 1 year, while participant was on study medication for the maintenance trial.
|
0.00%
0/31 • 6 weeks while participant was on study medication for treatment trial
For 1 year, while participant was on study medication for the maintenance trial.
|
|
Gastrointestinal disorders
Loss of appetite
|
4.2%
1/24 • Number of events 1 • 6 weeks while participant was on study medication for treatment trial
For 1 year, while participant was on study medication for the maintenance trial.
|
8.3%
2/24 • Number of events 2 • 6 weeks while participant was on study medication for treatment trial
For 1 year, while participant was on study medication for the maintenance trial.
|
0.00%
0/23 • 6 weeks while participant was on study medication for treatment trial
For 1 year, while participant was on study medication for the maintenance trial.
|
12.5%
4/32 • Number of events 4 • 6 weeks while participant was on study medication for treatment trial
For 1 year, while participant was on study medication for the maintenance trial.
|
6.5%
2/31 • Number of events 2 • 6 weeks while participant was on study medication for treatment trial
For 1 year, while participant was on study medication for the maintenance trial.
|
|
Gastrointestinal disorders
Nausea
|
12.5%
3/24 • Number of events 3 • 6 weeks while participant was on study medication for treatment trial
For 1 year, while participant was on study medication for the maintenance trial.
|
4.2%
1/24 • Number of events 1 • 6 weeks while participant was on study medication for treatment trial
For 1 year, while participant was on study medication for the maintenance trial.
|
8.7%
2/23 • Number of events 2 • 6 weeks while participant was on study medication for treatment trial
For 1 year, while participant was on study medication for the maintenance trial.
|
15.6%
5/32 • Number of events 5 • 6 weeks while participant was on study medication for treatment trial
For 1 year, while participant was on study medication for the maintenance trial.
|
12.9%
4/31 • Number of events 4 • 6 weeks while participant was on study medication for treatment trial
For 1 year, while participant was on study medication for the maintenance trial.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/24 • 6 weeks while participant was on study medication for treatment trial
For 1 year, while participant was on study medication for the maintenance trial.
|
0.00%
0/24 • 6 weeks while participant was on study medication for treatment trial
For 1 year, while participant was on study medication for the maintenance trial.
|
4.3%
1/23 • Number of events 1 • 6 weeks while participant was on study medication for treatment trial
For 1 year, while participant was on study medication for the maintenance trial.
|
9.4%
3/32 • Number of events 3 • 6 weeks while participant was on study medication for treatment trial
For 1 year, while participant was on study medication for the maintenance trial.
|
3.2%
1/31 • Number of events 1 • 6 weeks while participant was on study medication for treatment trial
For 1 year, while participant was on study medication for the maintenance trial.
|
|
Eye disorders
sensitive eyes
|
0.00%
0/24 • 6 weeks while participant was on study medication for treatment trial
For 1 year, while participant was on study medication for the maintenance trial.
|
0.00%
0/24 • 6 weeks while participant was on study medication for treatment trial
For 1 year, while participant was on study medication for the maintenance trial.
|
4.3%
1/23 • Number of events 1 • 6 weeks while participant was on study medication for treatment trial
For 1 year, while participant was on study medication for the maintenance trial.
|
3.1%
1/32 • Number of events 1 • 6 weeks while participant was on study medication for treatment trial
For 1 year, while participant was on study medication for the maintenance trial.
|
3.2%
1/31 • Number of events 1 • 6 weeks while participant was on study medication for treatment trial
For 1 year, while participant was on study medication for the maintenance trial.
|
|
Gastrointestinal disorders
abdominal pain
|
0.00%
0/24 • 6 weeks while participant was on study medication for treatment trial
For 1 year, while participant was on study medication for the maintenance trial.
|
4.2%
1/24 • Number of events 1 • 6 weeks while participant was on study medication for treatment trial
For 1 year, while participant was on study medication for the maintenance trial.
|
4.3%
1/23 • Number of events 1 • 6 weeks while participant was on study medication for treatment trial
For 1 year, while participant was on study medication for the maintenance trial.
|
0.00%
0/32 • 6 weeks while participant was on study medication for treatment trial
For 1 year, while participant was on study medication for the maintenance trial.
|
0.00%
0/31 • 6 weeks while participant was on study medication for treatment trial
For 1 year, while participant was on study medication for the maintenance trial.
|
|
Skin and subcutaneous tissue disorders
Rash on face and body
|
0.00%
0/24 • 6 weeks while participant was on study medication for treatment trial
For 1 year, while participant was on study medication for the maintenance trial.
|
4.2%
1/24 • Number of events 1 • 6 weeks while participant was on study medication for treatment trial
For 1 year, while participant was on study medication for the maintenance trial.
|
0.00%
0/23 • 6 weeks while participant was on study medication for treatment trial
For 1 year, while participant was on study medication for the maintenance trial.
|
0.00%
0/32 • 6 weeks while participant was on study medication for treatment trial
For 1 year, while participant was on study medication for the maintenance trial.
|
0.00%
0/31 • 6 weeks while participant was on study medication for treatment trial
For 1 year, while participant was on study medication for the maintenance trial.
|
|
General disorders
Unusual tiredness, or weakness
|
0.00%
0/24 • 6 weeks while participant was on study medication for treatment trial
For 1 year, while participant was on study medication for the maintenance trial.
|
0.00%
0/24 • 6 weeks while participant was on study medication for treatment trial
For 1 year, while participant was on study medication for the maintenance trial.
|
0.00%
0/23 • 6 weeks while participant was on study medication for treatment trial
For 1 year, while participant was on study medication for the maintenance trial.
|
12.5%
4/32 • Number of events 4 • 6 weeks while participant was on study medication for treatment trial
For 1 year, while participant was on study medication for the maintenance trial.
|
9.7%
3/31 • Number of events 3 • 6 weeks while participant was on study medication for treatment trial
For 1 year, while participant was on study medication for the maintenance trial.
|
|
Gastrointestinal disorders
Metallic taste
|
0.00%
0/24 • 6 weeks while participant was on study medication for treatment trial
For 1 year, while participant was on study medication for the maintenance trial.
|
0.00%
0/24 • 6 weeks while participant was on study medication for treatment trial
For 1 year, while participant was on study medication for the maintenance trial.
|
0.00%
0/23 • 6 weeks while participant was on study medication for treatment trial
For 1 year, while participant was on study medication for the maintenance trial.
|
6.2%
2/32 • Number of events 2 • 6 weeks while participant was on study medication for treatment trial
For 1 year, while participant was on study medication for the maintenance trial.
|
3.2%
1/31 • Number of events 1 • 6 weeks while participant was on study medication for treatment trial
For 1 year, while participant was on study medication for the maintenance trial.
|
|
Skin and subcutaneous tissue disorders
Calcium deposit in tissues outside of bones
|
0.00%
0/24 • 6 weeks while participant was on study medication for treatment trial
For 1 year, while participant was on study medication for the maintenance trial.
|
0.00%
0/24 • 6 weeks while participant was on study medication for treatment trial
For 1 year, while participant was on study medication for the maintenance trial.
|
0.00%
0/23 • 6 weeks while participant was on study medication for treatment trial
For 1 year, while participant was on study medication for the maintenance trial.
|
0.00%
0/32 • 6 weeks while participant was on study medication for treatment trial
For 1 year, while participant was on study medication for the maintenance trial.
|
3.2%
1/31 • Number of events 1 • 6 weeks while participant was on study medication for treatment trial
For 1 year, while participant was on study medication for the maintenance trial.
|
Additional Information
Helen Pappa, MD, MPH, Principal Investigator
children's Hospital Boston
Phone: 617-355-6058
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place