Trial Outcomes & Findings for Impact of Vitamin B12 Replacement on Epogen Dosing and Improvement of Quality of Life in Hemodialysis Patients (NCT NCT01876732)
NCT ID: NCT01876732
Last Updated: 2014-09-08
Results Overview
The effects of Vitamin B12 supplementation on erythropoitin alpha (Epogen) requirements in HD patients
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
132 participants
Primary outcome timeframe
Baseline and 4 months
Results posted on
2014-09-08
Participant Flow
Those with an MMA over 800nmol/L are given 1000mcg of IM vitamin B12 weekly for the first month and then monthly for 3 consecutive months.
Participant milestones
| Measure |
Vitamin B12
Those with an methylmalonic acid (MMA) over 800nmol/L are given 1000mcg of intramuscular (IM) vitamin B12 weekly for the first month and then monthly for 3 consecutive months.
Vitamin B 12: Consented subjects are screened for Vitamin B12 deficiency with measurements of serum vitamin B12 concentrations and plasma levels of MMA, drawn prior to the first hemodialysis (HD) session of the week. Those with an MMA over 800nmol/L are given 1000mcg of IM vitamin B12 weekly for the first month and then monthly for 3 consecutive months. Following therapy, serum B12, MMA levels, percent iron saturation, parathyroid levels and peripheral blood smear are to be repeated and compared to previous levels. Subjects also complete a Kidney Disease Quality of Life- 36 (KDQOL-36) prior to therapy and again post treatment.
|
|---|---|
|
Overall Study
STARTED
|
132
|
|
Overall Study
COMPLETED
|
57
|
|
Overall Study
NOT COMPLETED
|
75
|
Reasons for withdrawal
| Measure |
Vitamin B12
Those with an methylmalonic acid (MMA) over 800nmol/L are given 1000mcg of intramuscular (IM) vitamin B12 weekly for the first month and then monthly for 3 consecutive months.
Vitamin B 12: Consented subjects are screened for Vitamin B12 deficiency with measurements of serum vitamin B12 concentrations and plasma levels of MMA, drawn prior to the first hemodialysis (HD) session of the week. Those with an MMA over 800nmol/L are given 1000mcg of IM vitamin B12 weekly for the first month and then monthly for 3 consecutive months. Following therapy, serum B12, MMA levels, percent iron saturation, parathyroid levels and peripheral blood smear are to be repeated and compared to previous levels. Subjects also complete a Kidney Disease Quality of Life- 36 (KDQOL-36) prior to therapy and again post treatment.
|
|---|---|
|
Overall Study
MMA was not over 800mg/dL
|
75
|
Baseline Characteristics
Impact of Vitamin B12 Replacement on Epogen Dosing and Improvement of Quality of Life in Hemodialysis Patients
Baseline characteristics by cohort
| Measure |
Vitamin B12
n=57 Participants
Those with an MMA over 800nmol/L are given 1000mcg of IM vitamin B12 weekly for the first month and then monthly for 3 consecutive months.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
50 Participants
n=39 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=39 Participants
|
|
Age, Continuous
|
63.43 years
STANDARD_DEVIATION 14.6 • n=39 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=39 Participants
|
|
Region of Enrollment
United States
|
57 participants
n=39 Participants
|
PRIMARY outcome
Timeframe: Baseline and 4 monthsThe effects of Vitamin B12 supplementation on erythropoitin alpha (Epogen) requirements in HD patients
Outcome measures
| Measure |
Vitamin B12
n=57 Participants
Those with an MMA over 800nmol/L are given 1000mcg of IM vitamin B12 weekly for the first month and then monthly for 3 consecutive months.
Vitamin B12: Consented subjects are screened for Vitamin B12 deficiency with measurements of serum vitamin B12 concentrations and plasma levels of MMA, drawn prior to the first HD session of the week. Those with an MMA over 800nmol/L are given 1000mcg of IM vitamin B12 weekly for the first month and then monthly for 3 consecutive months. Following therapy, serum B12, MMA levels, percent iron saturation, parathyroid levels and peripheral blood smear are to be repeated and compared to previous levels. Subjects also complete a KDQOL-36 prior to therapy and again post treatment.
|
|---|---|
|
Change in Amount of Epogen Required
|
-16,572 unit/ml
Standard Deviation 41,902
|
SECONDARY outcome
Timeframe: 3 monthPopulation: Subjects were asked to complete a KDQOL-36 (Kidney Disease Quality of Life Instrument adopted for quality of life assessment of patients with kidney disease), once prior to therapy, and then again at the end of 3 months when therapy (when therapy is completed), was completed. Pre and post results will be compared.
The scoring procedure for the KDQOL-36 (Kidney Disease Quality of Life Instrument adopted for quality of life assessment of patients with kidney disease),first transforms the raw precoded numeric values of items to a 0-100 possible range with higher transformed scores reflecting a better quality of life. Each item is put on a 0 to100 range so that the lowest and highest possible scores are set at 0 and100, respectively. The results entered in the outcome data is the mean absolute difference between the mean pre-test score and the mean post-test score.
Outcome measures
| Measure |
Vitamin B12
n=57 Participants
Those with an MMA over 800nmol/L are given 1000mcg of IM vitamin B12 weekly for the first month and then monthly for 3 consecutive months.
Vitamin B12: Consented subjects are screened for Vitamin B12 deficiency with measurements of serum vitamin B12 concentrations and plasma levels of MMA, drawn prior to the first HD session of the week. Those with an MMA over 800nmol/L are given 1000mcg of IM vitamin B12 weekly for the first month and then monthly for 3 consecutive months. Following therapy, serum B12, MMA levels, percent iron saturation, parathyroid levels and peripheral blood smear are to be repeated and compared to previous levels. Subjects also complete a KDQOL-36 prior to therapy and again post treatment.
|
|---|---|
|
Change in Quality of Life
General health (pre-test)
|
36.92 Scores on a Scale
Standard Deviation 17.97
|
|
Change in Quality of Life
Emotional well-being (post-test)
|
64.00 Scores on a Scale
Standard Deviation 20.51
|
|
Change in Quality of Life
Role-emotional (pre-test)
|
35.56 Scores on a Scale
Standard Deviation 44.48
|
|
Change in Quality of Life
Physical functioning (pre to post change)
|
-2.33 Scores on a Scale
Standard Deviation 17.10
|
|
Change in Quality of Life
SF-12 mental composite (pre to post change)
|
2.94 Scores on a Scale
Standard Deviation 9.84
|
|
Change in Quality of Life
Social Function (pre-test)
|
56.67 Scores on a Scale
Standard Deviation 29.07
|
|
Change in Quality of Life
Social Function (post-test)
|
67.50 Scores on a Scale
Standard Deviation 24.91
|
|
Change in Quality of Life
Symptom/problem list (pre-test)
|
76.62 Scores on a Scale
Standard Deviation 18.60
|
|
Change in Quality of Life
Symptom/problem list (post-test)
|
75.69 Scores on a Scale
Standard Deviation 19.98
|
|
Change in Quality of Life
Effects of kidney disease (pre-test)
|
52.29 Scores on a Scale
Standard Deviation 26.08
|
|
Change in Quality of Life
Effects of kidney disease (post-test)
|
54.58 Scores on a Scale
Standard Deviation 26.96
|
|
Change in Quality of Life
Burden of kidney disease pre-test
|
43.75 Scores on a Scale
Standard Deviation 31.25
|
|
Change in Quality of Life
Burden of kidney disease (post-test)
|
37.50 Scores on a Scale
Standard Deviation 29.60
|
|
Change in Quality of Life
Work status (pre-test)
|
26.67 Scores on a Scale
Standard Deviation 32.00
|
|
Change in Quality of Life
Work status (post-test)
|
16.67 Scores on a Scale
Standard Deviation 30.86
|
|
Change in Quality of Life
Cognitive function (pre-test)
|
71.11 Scores on a Scale
Standard Deviation 28.91
|
|
Change in Quality of Life
Cognitive function (post-test)
|
72.44 Scores on a Scale
Standard Deviation 29.26
|
|
Change in Quality of Life
Quality of social interaction (pre-test)
|
70.67 Scores on a Scale
Standard Deviation 26.04
|
|
Change in Quality of Life
Quality of social interaction (post-test)
|
79.11 Scores on a Scale
Standard Deviation 18.15
|
|
Change in Quality of Life
Sexual function (pre-test)
|
87.50 Scores on a Scale
Standard Deviation 17.68
|
|
Change in Quality of Life
Sexual function (post-test)
|
100.00 Scores on a Scale
Standard Deviation 0.00
|
|
Change in Quality of Life
Sleep (pre-test)
|
51.00 Scores on a Scale
Standard Deviation 23.81
|
|
Change in Quality of Life
Sleep (post-test)
|
51.33 Scores on a Scale
Standard Deviation 24.03
|
|
Change in Quality of Life
Social support (pre-test)
|
77.78 Scores on a Scale
Standard Deviation 32.53
|
|
Change in Quality of Life
Social support (post-test)
|
77.78 Scores on a Scale
Standard Deviation 29.99
|
|
Change in Quality of Life
Dialysis staff encouragement (pre-test)
|
83.33 Scores on a Scale
Standard Deviation 15.43
|
|
Change in Quality of Life
Dialysis staff encouragement (post-test)
|
82.50 Scores on a Scale
Standard Deviation 16.90
|
|
Change in Quality of Life
Overall health (pre-test)
|
54.67 Scores on a Scale
Standard Deviation 24.46
|
|
Change in Quality of Life
Overall health (post-test)
|
60.00 Scores on a Scale
Standard Deviation 27.77
|
|
Change in Quality of Life
Patient satisfaction (pre-test)
|
71.11 Scores on a Scale
Standard Deviation 22.24
|
|
Change in Quality of Life
Patient satisfaction (post-test)
|
62.22 Scores on a Scale
Standard Deviation 17.21
|
|
Change in Quality of Life
Physical functioning (pre-test)
|
39.33 Scores on a Scale
Standard Deviation 30.41
|
|
Change in Quality of Life
Physical functioning (post-test)
|
37.00 Scores on a Scale
Standard Deviation 27.37
|
|
Change in Quality of Life
Role-physical (pre-test)
|
28.33 Scores on a Scale
Standard Deviation 38.81
|
|
Change in Quality of Life
Role-physical (post-test)
|
40.00 Scores on a Scale
Standard Deviation 40.97
|
|
Change in Quality of Life
Pain (pre-test)
|
55.83 Scores on a Scale
Standard Deviation 36.57
|
|
Change in Quality of Life
Pain (post-test)
|
65.83 Scores on a Scale
Standard Deviation 33.54
|
|
Change in Quality of Life
General health (post-test)
|
44.33 Scores on a Scale
Standard Deviation 24.56
|
|
Change in Quality of Life
Emotional well-being (pre-test)
|
68.00 Scores on a Scale
Standard Deviation 21.43
|
|
Change in Quality of Life
Role-emotional (post-test)
|
55.56 Scores on a Scale
Standard Deviation 46.58
|
|
Change in Quality of Life
Energy/fatigue (pre-test)
|
40.33 Scores on a Scale
Standard Deviation 27.48
|
|
Change in Quality of Life
Energy/fatigue (post-test)
|
48.00 Scores on a Scale
Standard Deviation 17.61
|
|
Change in Quality of Life
SF-12 physical composite (pre-test)
|
34.06 Scores on a Scale
Standard Deviation 8.81
|
|
Change in Quality of Life
SF-12 physical composite (post-test)
|
36.12 Scores on a Scale
Standard Deviation 9.44
|
|
Change in Quality of Life
SF-12 mental composite (pre-test)
|
41.88 Scores on a Scale
Standard Deviation 11.45
|
|
Change in Quality of Life
SF-12 mental composite (post-test)
|
44.83 Scores on a Scale
Standard Deviation 11.18
|
|
Change in Quality of Life
Social function (pre to post change)
|
10.83 Scores on a Scale
Standard Deviation 19.40
|
|
Change in Quality of Life
Symptom/problem list (pre to post change)
|
-3.13 Scores on a Scale
Standard Deviation 14.72
|
|
Change in Quality of Life
Effects of kidney disease (pre to post change)
|
2.29 Scores on a Scale
Standard Deviation 9.99
|
|
Change in Quality of Life
Burden of kidney disease (pre to post change)
|
-6.25 Scores on a Scale
Standard Deviation 17.52
|
|
Change in Quality of Life
Work status (pre to post change)
|
-10.00 Scores on a Scale
Standard Deviation 20.70
|
|
Change in Quality of Life
Cognitive function (pre to post change)
|
1.33 Scores on a Scale
Standard Deviation 28.75
|
|
Change in Quality of Life
Quality of social interaction (pre to post change)
|
8.44 Scores on a Scale
Standard Deviation 25.63
|
|
Change in Quality of Life
Sleep (pre to post change)
|
0.33 Scores on a Scale
Standard Deviation 20.81
|
|
Change in Quality of Life
Social support (pre to post change)
|
0.00 Scores on a Scale
Standard Deviation 39.34
|
|
Change in Quality of Life
Dialysis staff encouragement (pre to post change)
|
-0.83 Scores on a Scale
Standard Deviation 21.89
|
|
Change in Quality of Life
Overall health (pre to post change)
|
5.33 Scores on a Scale
Standard Deviation 19.95
|
|
Change in Quality of Life
Patient satisfaction (pre to post change)
|
-8.89 Scores on a Scale
Standard Deviation 15.26
|
|
Change in Quality of Life
Role-physical (pre to post change)
|
11.67 Scores on a Scale
Standard Deviation 43.16
|
|
Change in Quality of Life
Pain (pre to post change)
|
10.00 Scores on a Scale
Standard Deviation 36.29
|
|
Change in Quality of Life
General health (pre to post change)
|
7.42 Scores on a Scale
Standard Deviation 15.81
|
|
Change in Quality of Life
Emotional well-being (pre to post change)
|
-4.00 Scores on a Scale
Standard Deviation 23.71
|
|
Change in Quality of Life
Role-emotional (pre to post change)
|
20.00 Scores on a Scale
Standard Deviation 46.80
|
|
Change in Quality of Life
Energy/fatigue (pre to post change)
|
7.67 Scores on a Scale
Standard Deviation 21.29
|
|
Change in Quality of Life
SF-12 physical composite (pre to post change)
|
2.06 Scores on a Scale
Standard Deviation 8.63
|
Adverse Events
Vitamin B12
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