Trial Outcomes & Findings for Vitamin D as a Modifier of Serum Hepcidin in Children With Chronic Kidney Disease (NCT NCT01532349)
NCT ID: NCT01532349
Last Updated: 2017-06-14
Results Overview
The null hypothesis to be tested is that Vitamin D supplementation will not be associated with a decrease in serum hepcidin over the study period. Statistical analysis will be performed as intention-to-treat.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
34 participants
Primary outcome timeframe
change from baseline to up to three months
Results posted on
2017-06-14
Participant Flow
Participant milestones
| Measure |
400 IU Vitamin D
Children will be randomly allocated to receive cholecalciferol supplementation 400 IU/day (2,800 IU/weekly), which is the recommended dietary allowance. Study participants will be prescribed any clinically indicated additional cholecalciferol supplementation once the 3-month laboratory measures have been obtained, based on serum 25D levels at the end of the study period.
|
4000 IU Vitamin D
Children will be randomly allocated to receive cholecalciferol supplementation 4000 IU/day (28,000 IU weekly) according to the KDOQI recommended supplementation for children with mild 25D deficiency. Study participants will be prescribed any clinically indicated additional cholecalciferol supplementation once the 3-month laboratory measures have been obtained, based on serum 25D levels at the end of the study period.
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
17
|
|
Overall Study
COMPLETED
|
15
|
12
|
|
Overall Study
NOT COMPLETED
|
2
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Vitamin D as a Modifier of Serum Hepcidin in Children With Chronic Kidney Disease
Baseline characteristics by cohort
| Measure |
400 IU Vitamin D
n=17 Participants
Children were randomly allocated to receive cholecalciferol supplementation 400 IU/day (2,800 IU/weekly), which is the recommended dietary allowance. Study participants will be prescribed any clinically indicated additional cholecalciferol supplementation once the 3-month laboratory measures have been obtained, based on serum 25D levels at the end of the study period.
|
4000 IU Vitamin D
n=17 Participants
Children were be randomly allocated to receive cholecalciferol supplementation 4000 IU/day (28,000 IU weekly) according to the KDOQI recommended supplementation for children with mild 25D deficiency. Study participants will be prescribed any clinically indicated additional cholecalciferol supplementation once the 3-month laboratory measures have been obtained, based on serum 25D levels at the end of the study period.
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
13 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
10.9 years
STANDARD_DEVIATION 6.3 • n=5 Participants
|
10.8 years
STANDARD_DEVIATION 5.5 • n=7 Participants
|
10.9 years
STANDARD_DEVIATION 5.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=5 Participants
|
17 participants
n=7 Participants
|
34 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: change from baseline to up to three monthsThe null hypothesis to be tested is that Vitamin D supplementation will not be associated with a decrease in serum hepcidin over the study period. Statistical analysis will be performed as intention-to-treat.
Outcome measures
| Measure |
400 IU Vitamin D
n=15 Participants
Children were randomly allocated to receive cholecalciferol supplementation 400 IU/day (2,800 IU/weekly), which is the recommended dietary allowance. Study participants will be prescribed any clinically indicated additional cholecalciferol supplementation once the 3-month laboratory measures have been obtained, based on serum 25D levels at the end of the study period.
Serum hepcidin was the primary outcome variable and was quantified at all visits.
|
4000 IU Vitamin D
n=12 Participants
Children were be randomly allocated to receive cholecalciferol supplementation 4000 IU/day (28,000 IU weekly) according to the KDOQI recommended supplementation for children with mild 25D deficiency. Study participants will be prescribed any clinically indicated additional cholecalciferol supplementation once the 3-month laboratory measures have been obtained, based on serum 25D levels at the end of the study period.
Serum hepcidin was the primary outcome variable and was quantified at all visits.
|
|---|---|---|
|
Change in Serum Hepcidin With Vitamin D Intervention for Children With Chronic Kidney Disease
|
48.2 ng/ml
Interval 38.0 to 63.0
|
75.4 ng/ml
Interval 38.6 to 123.12
|
Adverse Events
400 IU Vitamin D
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
4000 IU Vitamin D
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
400 IU Vitamin D
n=17 participants at risk
Children were randomly allocated to receive cholecalciferol supplementation 400 IU/day (2,800 IU/weekly), which is the recommended dietary allowance. Study participants will be prescribed any clinically indicated additional cholecalciferol supplementation once the 3-month laboratory measures have been obtained, based on serum 25D levels at the end of the study period.
Serum hepcidin was the primary outcome variable and was quantified at all visits.
|
4000 IU Vitamin D
n=17 participants at risk
Children were be randomly allocated to receive cholecalciferol supplementation 4000 IU/day (28,000 IU weekly) according to the KDOQI recommended supplementation for children with mild 25D deficiency. Study participants will be prescribed any clinically indicated additional cholecalciferol supplementation once the 3-month laboratory measures have been obtained, based on serum 25D levels at the end of the study period.
Serum hepcidin was the primary outcome variable and was quantified at all visits.
|
|---|---|---|
|
Renal and urinary disorders
Hyperphosphatemia
|
0.00%
0/17 • 3 months
|
5.9%
1/17 • Number of events 1 • 3 months
|
|
Endocrine disorders
Hypervitaminosis D
|
0.00%
0/17 • 3 months
|
17.6%
3/17 • Number of events 3 • 3 months
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/17 • 3 months
|
5.9%
1/17 • Number of events 1 • 3 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place