Trial Outcomes & Findings for DIVINE: Dialysis Infection and Vitamin D In New England (NCT NCT00892099)
NCT ID: NCT00892099
Last Updated: 2018-04-20
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
105 participants
Primary outcome timeframe
12 weeks
Results posted on
2018-04-20
Participant Flow
Participant milestones
| Measure |
High Dose Ergocalciferol
Receives 50,000 IU of ergocalciferol weekly
Ergocalciferol: 50,000 IU tablet given weekly
|
Low Dose Ergocalciferol
Receives 50,000 IU of ergocalciferol per month
Ergocalciferol: 50,000 IU tablet given monthly
|
Placebo
Receives no ergocalciferol
Placebo: Placebo equivalent of ergocalciferol, given weekly as one tablet
|
|---|---|---|---|
|
Overall Study
STARTED
|
36
|
33
|
36
|
|
Overall Study
COMPLETED
|
31
|
32
|
29
|
|
Overall Study
NOT COMPLETED
|
5
|
1
|
7
|
Reasons for withdrawal
| Measure |
High Dose Ergocalciferol
Receives 50,000 IU of ergocalciferol weekly
Ergocalciferol: 50,000 IU tablet given weekly
|
Low Dose Ergocalciferol
Receives 50,000 IU of ergocalciferol per month
Ergocalciferol: 50,000 IU tablet given monthly
|
Placebo
Receives no ergocalciferol
Placebo: Placebo equivalent of ergocalciferol, given weekly as one tablet
|
|---|---|---|---|
|
Overall Study
Death
|
1
|
0
|
1
|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
|
Overall Study
replocated
|
1
|
0
|
2
|
|
Overall Study
Prolonged hospitalization
|
1
|
0
|
1
|
|
Overall Study
no further details
|
1
|
0
|
1
|
|
Overall Study
kidney function recovered
|
0
|
1
|
0
|
|
Overall Study
investigator decision
|
0
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
Baseline Characteristics
DIVINE: Dialysis Infection and Vitamin D In New England
Baseline characteristics by cohort
| Measure |
High Dose Ergocalciferol
n=36 Participants
Receives 50,000 IU of ergocalciferol weekly
Ergocalciferol: 50,000 IU tablet given weekly
|
Low Dose Ergocalciferol
n=33 Participants
Receives 50,000 IU of ergocalciferol per month
Ergocalciferol: 50,000 IU tablet given monthly
|
Placebo
n=36 Participants
Receives no ergocalciferol
Placebo: Placebo equivalent of ergocalciferol, given weekly as one tablet
|
Total
n=105 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
53 years
STANDARD_DEVIATION 17 • n=5 Participants
|
58 years
STANDARD_DEVIATION 16 • n=7 Participants
|
59 years
STANDARD_DEVIATION 17 • n=5 Participants
|
57 years
STANDARD_DEVIATION 17 • n=4 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
82 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
32 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
90 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
6 Participants
n=4 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
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
13 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
66 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
25(OH) vitamin D
|
21.8 ng/ml
STANDARD_DEVIATION 7 • n=5 Participants
|
22.3 ng/ml
STANDARD_DEVIATION 6.5 • n=7 Participants
|
21.7 ng/ml
STANDARD_DEVIATION 7.3 • n=5 Participants
|
21.9 ng/ml
STANDARD_DEVIATION 6.9 • n=4 Participants
|
PRIMARY outcome
Timeframe: 12 weeksOutcome measures
| Measure |
High Dose Ergocalciferol
n=36 Participants
Receives 50,000 IU of ergocalciferol weekly
Ergocalciferol: 50,000 IU tablet given weekly
|
Low Dose Ergocalciferol
n=33 Participants
Receives 50,000 IU of ergocalciferol per month
Ergocalciferol: 50,000 IU tablet given monthly
|
Placebo
n=36 Participants
Receives no ergocalciferol
Placebo: Placebo equivalent of ergocalciferol, given weekly as one tablet
|
|---|---|---|---|
|
Serum 25D Level
|
49.8 ng/ml
Standard Deviation 2.3
|
38.3 ng/ml
Standard Deviation 2.4
|
27.3 ng/ml
Standard Deviation 2.3
|
SECONDARY outcome
Timeframe: every 4 weeks for 12 weeksPopulation: Subject receiving treatment
serum calcium levels (mg/dL)
Outcome measures
| Measure |
High Dose Ergocalciferol
n=36 Participants
Receives 50,000 IU of ergocalciferol weekly
Ergocalciferol: 50,000 IU tablet given weekly
|
Low Dose Ergocalciferol
n=33 Participants
Receives 50,000 IU of ergocalciferol per month
Ergocalciferol: 50,000 IU tablet given monthly
|
Placebo
n=36 Participants
Receives no ergocalciferol
Placebo: Placebo equivalent of ergocalciferol, given weekly as one tablet
|
|---|---|---|---|
|
Serum Calcium
Visit 1
|
8.8 mg/dl
Standard Error 0.1
|
8.7 mg/dl
Standard Error 0.1
|
8.8 mg/dl
Standard Error 0.1
|
|
Serum Calcium
Visit 2
|
9.1 mg/dl
Standard Error 0.1
|
8.9 mg/dl
Standard Error 0.1
|
9.0 mg/dl
Standard Error 0.1
|
|
Serum Calcium
Visit 3
|
9.3 mg/dl
Standard Error 0.1
|
9.1 mg/dl
Standard Error 0.1
|
9.3 mg/dl
Standard Error 0.1
|
|
Serum Calcium
Visit 4
|
9.1 mg/dl
Standard Error 0.1
|
9.1 mg/dl
Standard Error 0.1
|
9.1 mg/dl
Standard Error 0.1
|
SECONDARY outcome
Timeframe: every 4 weeks for 12 weeksPopulation: Subject receiving treatment
serum phosphate levels (mmol/L)
Outcome measures
| Measure |
High Dose Ergocalciferol
n=36 Participants
Receives 50,000 IU of ergocalciferol weekly
Ergocalciferol: 50,000 IU tablet given weekly
|
Low Dose Ergocalciferol
n=33 Participants
Receives 50,000 IU of ergocalciferol per month
Ergocalciferol: 50,000 IU tablet given monthly
|
Placebo
n=36 Participants
Receives no ergocalciferol
Placebo: Placebo equivalent of ergocalciferol, given weekly as one tablet
|
|---|---|---|---|
|
Serum Phosphate
Visit 1
|
4.2 mmol/L
Standard Error 0.2
|
4.2 mmol/L
Standard Error 0.2
|
4.1 mmol/L
Standard Error 0.2
|
|
Serum Phosphate
Visit 2
|
4.7 mmol/L
Standard Error 0.3
|
4.7 mmol/L
Standard Error 0.3
|
4.8 mmol/L
Standard Error 0.3
|
|
Serum Phosphate
Visit 3
|
4.9 mmol/L
Standard Error 0.3
|
5.2 mmol/L
Standard Error 0.3
|
5 mmol/L
Standard Error 0.4
|
|
Serum Phosphate
Visit 4
|
4.7 mmol/L
Standard Error 0.3
|
5.4 mmol/L
Standard Error 0.3
|
4.9 mmol/L
Standard Error 0.3
|
SECONDARY outcome
Timeframe: every 4 weeks for 12 weeksPopulation: Subject receiving treatment
serum 25-OH vitamin D levels (ng/mL)
Outcome measures
| Measure |
High Dose Ergocalciferol
n=36 Participants
Receives 50,000 IU of ergocalciferol weekly
Ergocalciferol: 50,000 IU tablet given weekly
|
Low Dose Ergocalciferol
n=33 Participants
Receives 50,000 IU of ergocalciferol per month
Ergocalciferol: 50,000 IU tablet given monthly
|
Placebo
n=36 Participants
Receives no ergocalciferol
Placebo: Placebo equivalent of ergocalciferol, given weekly as one tablet
|
|---|---|---|---|
|
Serum 25-OH Vitamin D
Visit 1
|
21.8 ng/mL
Standard Error 1.2
|
21.7 ng/mL
Standard Error 1.2
|
22.3 ng/mL
Standard Error 1.2
|
|
Serum 25-OH Vitamin D
Visit 2
|
42.2 ng/mL
Standard Error 2.0
|
33.6 ng/mL
Standard Error 2
|
27.6 ng/mL
Standard Error 1.9
|
|
Serum 25-OH Vitamin D
Visit 3
|
48.9 ng/mL
Standard Error 2.2
|
35.6 ng/mL
Standard Error 2.2
|
27 ng/mL
Standard Error 2.1
|
|
Serum 25-OH Vitamin D
Visit 4
|
49.8 ng/mL
Standard Error 2.3
|
38.3 ng/mL
Standard Error 2.4
|
27.4 ng/mL
Standard Error 2.3
|
SECONDARY outcome
Timeframe: At week 12Population: Subject receiving treatment
serum 1,25(OH) vitamin D levels (pg/mL)
Outcome measures
| Measure |
High Dose Ergocalciferol
n=36 Participants
Receives 50,000 IU of ergocalciferol weekly
Ergocalciferol: 50,000 IU tablet given weekly
|
Low Dose Ergocalciferol
n=33 Participants
Receives 50,000 IU of ergocalciferol per month
Ergocalciferol: 50,000 IU tablet given monthly
|
Placebo
n=36 Participants
Receives no ergocalciferol
Placebo: Placebo equivalent of ergocalciferol, given weekly as one tablet
|
|---|---|---|---|
|
Serum 1,25(OH)2 Levels
|
95 pg/mL
Interval 66.0 to 135.0
|
100 pg/mL
Interval 68.0 to 140.0
|
120 pg/mL
Interval 62.0 to 149.0
|
SECONDARY outcome
Timeframe: every 4 weeks for 12 weeksPopulation: Subject receiving treatment
serum PTH levels (pg/mL)
Outcome measures
| Measure |
High Dose Ergocalciferol
n=36 Participants
Receives 50,000 IU of ergocalciferol weekly
Ergocalciferol: 50,000 IU tablet given weekly
|
Low Dose Ergocalciferol
n=33 Participants
Receives 50,000 IU of ergocalciferol per month
Ergocalciferol: 50,000 IU tablet given monthly
|
Placebo
n=36 Participants
Receives no ergocalciferol
Placebo: Placebo equivalent of ergocalciferol, given weekly as one tablet
|
|---|---|---|---|
|
Parathyroid Hormone
Visit 3
|
255 pg/mL
Standard Error 1
|
195 pg/mL
Standard Error 1
|
196 pg/mL
Standard Error 1
|
|
Parathyroid Hormone
Visit 4
|
245 pg/mL
Standard Error 1.1
|
216 pg/mL
Standard Error 1
|
215 pg/mL
Standard Error 1
|
|
Parathyroid Hormone
Visit 1
|
281 pg/mL
Standard Error 1
|
214 pg/mL
Standard Error 1
|
243 pg/mL
Standard Error 1
|
|
Parathyroid Hormone
Visit 2
|
253 pg/mL
Standard Error 1
|
195 pg/mL
Standard Error 1
|
243 pg/mL
Standard Error 1
|
Adverse Events
High Dose Ergocalciferol
Serious events: 0 serious events
Other events: 33 other events
Deaths: 0 deaths
Low Dose Ergocalciferol
Serious events: 0 serious events
Other events: 26 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 28 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
High Dose Ergocalciferol
n=36 participants at risk
Receives 50,000 IU of ergocalciferol weekly
Ergocalciferol: 50,000 IU tablet given weekly
|
Low Dose Ergocalciferol
n=33 participants at risk
Receives 50,000 IU of ergocalciferol per month
Ergocalciferol: 50,000 IU tablet given monthly
|
Placebo
n=36 participants at risk
Receives no ergocalciferol
Placebo: Placebo equivalent of ergocalciferol, given weekly as one tablet
|
|---|---|---|---|
|
Renal and urinary disorders
Elevated phosphorus
|
36.1%
13/36 • Number of events 13
|
39.4%
13/33 • Number of events 13
|
41.7%
15/36 • Number of events 15
|
|
Renal and urinary disorders
Elevated calcium
|
5.6%
2/36 • Number of events 2
|
3.0%
1/33 • Number of events 1
|
2.8%
1/36 • Number of events 1
|
|
Endocrine disorders
Elevated PTH
|
16.7%
6/36 • Number of events 6
|
6.1%
2/33 • Number of events 2
|
11.1%
4/36 • Number of events 4
|
|
Renal and urinary disorders
Elevated potassium
|
0.00%
0/36
|
0.00%
0/33
|
8.3%
3/36 • Number of events 3
|
|
Renal and urinary disorders
Elevated white blood count
|
0.00%
0/36
|
0.00%
0/33
|
2.8%
1/36 • Number of events 1
|
|
Metabolism and nutrition disorders
Low albumin
|
0.00%
0/36
|
0.00%
0/33
|
2.8%
1/36 • Number of events 1
|
|
Surgical and medical procedures
Hospitalization
|
38.9%
14/36 • Number of events 14
|
33.3%
11/33 • Number of events 11
|
36.1%
13/36 • Number of events 13
|
|
Infections and infestations
Infection
|
30.6%
11/36 • Number of events 11
|
33.3%
11/33 • Number of events 11
|
22.2%
8/36 • Number of events 8
|
|
Cardiac disorders
Cardiovascular
|
16.7%
6/36 • Number of events 6
|
6.1%
2/33 • Number of events 2
|
8.3%
3/36 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory
|
8.3%
3/36 • Number of events 3
|
6.1%
2/33 • Number of events 2
|
8.3%
3/36 • Number of events 3
|
|
Gastrointestinal disorders
Constipation
|
5.6%
2/36 • Number of events 2
|
0.00%
0/33
|
2.8%
1/36 • Number of events 1
|
|
Cardiac disorders
Fluid overload
|
2.8%
1/36 • Number of events 1
|
0.00%
0/33
|
5.6%
2/36 • Number of events 2
|
|
Gastrointestinal disorders
Nausea/vomiting/diarrhea
|
5.6%
2/36 • Number of events 2
|
12.1%
4/33 • Number of events 4
|
8.3%
3/36 • Number of events 3
|
|
Cardiac disorders
Hypotension
|
0.00%
0/36
|
9.1%
3/33 • Number of events 3
|
5.6%
2/36 • Number of events 2
|
|
Cardiac disorders
Hypertension
|
2.8%
1/36 • Number of events 1
|
0.00%
0/33
|
0.00%
0/36
|
|
Musculoskeletal and connective tissue disorders
Fall
|
8.3%
3/36 • Number of events 3
|
9.1%
3/33 • Number of events 3
|
2.8%
1/36 • Number of events 1
|
|
General disorders
Other
|
11.1%
4/36 • Number of events 4
|
6.1%
2/33 • Number of events 2
|
5.6%
2/36 • Number of events 2
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place