Trial Outcomes & Findings for Folic Acid for Vascular Outcome Reduction In Transplantation (FAVORIT) (NCT NCT00064753)
NCT ID: NCT00064753
Last Updated: 2017-10-18
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
4110 participants
Primary outcome timeframe
Up to 6 years (mean 4 years)
Results posted on
2017-10-18
Participant Flow
Trial enrolled 4110 participants from August 2002 through January 2007 at 20 clinical sites in the US, Canada, and Brazil.
Participant milestones
| Measure |
High Dose Multivitamin
Multivitamin with increased folic acid, vitamin B6 and vitamin B12
High Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 50 mg Folic acid: 5.0 mg Vitamin B12: 1.0 mg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg
|
Low Dose Multivitamin
Multivitamin devoid of folic acid and with estimated average requirement (EAR) amounts of vitamin B6 and vitamin B12
Low Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 1.4 mg Folic acid: 0.0 mg Vitamin B12: 2.0 mcg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg
|
|---|---|---|
|
Overall Study
STARTED
|
2056
|
2054
|
|
Overall Study
COMPLETED
|
1382
|
1406
|
|
Overall Study
NOT COMPLETED
|
674
|
648
|
Reasons for withdrawal
| Measure |
High Dose Multivitamin
Multivitamin with increased folic acid, vitamin B6 and vitamin B12
High Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 50 mg Folic acid: 5.0 mg Vitamin B12: 1.0 mg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg
|
Low Dose Multivitamin
Multivitamin devoid of folic acid and with estimated average requirement (EAR) amounts of vitamin B6 and vitamin B12
Low Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 1.4 mg Folic acid: 0.0 mg Vitamin B12: 2.0 mcg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg
|
|---|---|---|
|
Overall Study
Death
|
251
|
242
|
|
Overall Study
Withdrawal by Subject
|
198
|
171
|
|
Overall Study
Lost to Follow-up
|
225
|
235
|
Baseline Characteristics
Folic Acid for Vascular Outcome Reduction In Transplantation (FAVORIT)
Baseline characteristics by cohort
| Measure |
High Dose Multivitamin
n=2056 Participants
Multivitamin with increased folic acid, vitamin B6 and vitamin B12
High Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 50 mg Folic acid: 5.0 mg Vitamin B12: 1.0 mg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg
|
Low Dose Multivitamin
n=2054 Participants
Multivitamin devoid of folic acid and with EAR amounts of vitamin B6 and vitamin B12
Low Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 1.4 mg Folic acid: 0.0 mg Vitamin B12: 2.0 mcg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg
|
Total
n=4110 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52 years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
52 years
STANDARD_DEVIATION 9.5 • n=7 Participants
|
52 years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
767 Participants
n=5 Participants
|
761 Participants
n=7 Participants
|
1528 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1289 Participants
n=5 Participants
|
1293 Participants
n=7 Participants
|
2582 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
249 participants
n=5 Participants
|
249 participants
n=7 Participants
|
498 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
1500 participants
n=5 Participants
|
1500 participants
n=7 Participants
|
3000 participants
n=5 Participants
|
|
Region of Enrollment
Brazil
|
307 participants
n=5 Participants
|
305 participants
n=7 Participants
|
612 participants
n=5 Participants
|
|
Graft vintage
|
6 years
STANDARD_DEVIATION 5.1 • n=5 Participants
|
5 years
STANDARD_DEVIATION 5.0 • n=7 Participants
|
5 years
STANDARD_DEVIATION 5.0 • n=5 Participants
|
|
History of CVD
History of CVD
|
406 participants
n=5 Participants
|
414 participants
n=7 Participants
|
820 participants
n=5 Participants
|
|
History of CVD
No History of CVD
|
1650 participants
n=5 Participants
|
1640 participants
n=7 Participants
|
3290 participants
n=5 Participants
|
|
History of diabetes mellitus
History of diabetes mellitus
|
813 participants
n=5 Participants
|
850 participants
n=7 Participants
|
1663 participants
n=5 Participants
|
|
History of diabetes mellitus
No history of diabetes mellitus
|
1243 participants
n=5 Participants
|
1204 participants
n=7 Participants
|
2447 participants
n=5 Participants
|
|
Prevalent hypertension
Prevalent hypertension
|
1879 participants
n=5 Participants
|
1899 participants
n=7 Participants
|
3778 participants
n=5 Participants
|
|
Prevalent hypertension
Non-prevalent hypertension
|
177 participants
n=5 Participants
|
155 participants
n=7 Participants
|
332 participants
n=5 Participants
|
|
Body mass index
|
29 kg/m^2
STANDARD_DEVIATION 6.2 • n=5 Participants
|
29 kg/m^2
STANDARD_DEVIATION 6.3 • n=7 Participants
|
29 kg/m^2
STANDARD_DEVIATION 6.2 • n=5 Participants
|
|
Current smoker
Current smoker
|
230 participants
n=5 Participants
|
221 participants
n=7 Participants
|
451 participants
n=5 Participants
|
|
Current smoker
Not current smoker
|
1826 participants
n=5 Participants
|
1833 participants
n=7 Participants
|
3659 participants
n=5 Participants
|
|
Total cholesterol
|
4.8 mmol/L
STANDARD_DEVIATION 1.2 • n=5 Participants
|
4.8 mmol/L
STANDARD_DEVIATION 1.1 • n=7 Participants
|
4.8 mmol/L
STANDARD_DEVIATION 1.1 • n=5 Participants
|
|
High-density lipoprotein cholesterol
|
1.2 mmol/L
STANDARD_DEVIATION 0.4 • n=5 Participants
|
1.2 mmol/L
STANDARD_DEVIATION 0.4 • n=7 Participants
|
1.2 mmol/L
STANDARD_DEVIATION 0.4 • n=5 Participants
|
|
Calculated or direct low-density lipoprotein cholesterol
|
2.6 mmol/L
STANDARD_DEVIATION 0.9 • n=5 Participants
|
2.6 mmol/L
STANDARD_DEVIATION 0.9 • n=7 Participants
|
2.6 mmol/L
STANDARD_DEVIATION 0.9 • n=5 Participants
|
|
Triglycerides levels
|
2.3 mmol/L
STANDARD_DEVIATION 2.5 • n=5 Participants
|
2.2 mmol/L
STANDARD_DEVIATION 1.6 • n=7 Participants
|
2.2 mmol/L
STANDARD_DEVIATION 2.1 • n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 6 years (mean 4 years)Population: Censored at 3 months after return to dialysis
Outcome measures
| Measure |
High Dose Multivitamin
n=2029 Participants
Multivitamin with increased folic acid, vitamin B6 and vitamin B12
High Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 50 mg Folic acid: 5.0 mg Vitamin B12: 1.0 mg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg
|
Low Dose Multivitamin
n=2029 Participants
Multivitamin devoid of folic acid and with EAR amounts of vitamin B6 and vitamin B12
Low Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 1.4 mg Folic acid: 0.0 mg Vitamin B12: 2.0 mcg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg
|
|---|---|---|
|
Recurrent or de Novo Arteriosclerotic Cardiovascular Disease (CVD) Defined as the Occurrence of Non-fatal or Fatal Arteriosclerotic Outcomes Including Coronary Heart, Cerebrovascular, and Peripheral Vascular Disease Events
|
269 participants
|
278 participants
|
SECONDARY outcome
Timeframe: Up to 6 years (mean 4 years)Population: Intention-to-treat
Outcome measures
| Measure |
High Dose Multivitamin
n=2029 Participants
Multivitamin with increased folic acid, vitamin B6 and vitamin B12
High Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 50 mg Folic acid: 5.0 mg Vitamin B12: 1.0 mg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg
|
Low Dose Multivitamin
n=2029 Participants
Multivitamin devoid of folic acid and with EAR amounts of vitamin B6 and vitamin B12
Low Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 1.4 mg Folic acid: 0.0 mg Vitamin B12: 2.0 mcg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg
|
|---|---|---|
|
Renal Graft Failure
|
181 participants
|
162 participants
|
SECONDARY outcome
Timeframe: Up to 6 years (mean 4 years)censored at 3 months after return to dialysis
Outcome measures
| Measure |
High Dose Multivitamin
n=2054 Participants
Multivitamin with increased folic acid, vitamin B6 and vitamin B12
High Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 50 mg Folic acid: 5.0 mg Vitamin B12: 1.0 mg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg
|
Low Dose Multivitamin
n=2049 Participants
Multivitamin devoid of folic acid and with EAR amounts of vitamin B6 and vitamin B12
Low Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 1.4 mg Folic acid: 0.0 mg Vitamin B12: 2.0 mcg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg
|
|---|---|---|
|
Mortality (All-cause)
|
217 participants
|
214 participants
|
SECONDARY outcome
Timeframe: Up to 6 years (mean 4 years)censored at 3 months after return to dialysis
Outcome measures
| Measure |
High Dose Multivitamin
n=2056 Participants
Multivitamin with increased folic acid, vitamin B6 and vitamin B12
High Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 50 mg Folic acid: 5.0 mg Vitamin B12: 1.0 mg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg
|
Low Dose Multivitamin
n=2054 Participants
Multivitamin devoid of folic acid and with EAR amounts of vitamin B6 and vitamin B12
Low Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 1.4 mg Folic acid: 0.0 mg Vitamin B12: 2.0 mcg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg
|
|---|---|---|
|
Fatal/Non-fatal Myocardial Infarction (MI)
|
90 participants
|
86 participants
|
SECONDARY outcome
Timeframe: Up to 6 years (mean 4 years)censored at 3 months after return to dialysis
Outcome measures
| Measure |
High Dose Multivitamin
n=2056 Participants
Multivitamin with increased folic acid, vitamin B6 and vitamin B12
High Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 50 mg Folic acid: 5.0 mg Vitamin B12: 1.0 mg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg
|
Low Dose Multivitamin
n=2054 Participants
Multivitamin devoid of folic acid and with EAR amounts of vitamin B6 and vitamin B12
Low Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 1.4 mg Folic acid: 0.0 mg Vitamin B12: 2.0 mcg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg
|
|---|---|---|
|
Fatal/Non-fatal Stroke
|
35 participants
|
32 participants
|
SECONDARY outcome
Timeframe: Up to 6 years (mean 4 years)censored at 3 months after return to dialysis
Outcome measures
| Measure |
High Dose Multivitamin
n=2056 Participants
Multivitamin with increased folic acid, vitamin B6 and vitamin B12
High Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 50 mg Folic acid: 5.0 mg Vitamin B12: 1.0 mg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg
|
Low Dose Multivitamin
n=2054 Participants
Multivitamin devoid of folic acid and with EAR amounts of vitamin B6 and vitamin B12
Low Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 1.4 mg Folic acid: 0.0 mg Vitamin B12: 2.0 mcg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg
|
|---|---|---|
|
Resuscitated Sudden Death (RSD)
|
7 participants
|
9 participants
|
SECONDARY outcome
Timeframe: Up to 6 years (mean 4 years)Population: P was calculated with stratified proportional hazards models stratified by country
censored at 3 months after return to dialysis
Outcome measures
| Measure |
High Dose Multivitamin
n=2056 Participants
Multivitamin with increased folic acid, vitamin B6 and vitamin B12
High Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 50 mg Folic acid: 5.0 mg Vitamin B12: 1.0 mg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg
|
Low Dose Multivitamin
n=2054 Participants
Multivitamin devoid of folic acid and with EAR amounts of vitamin B6 and vitamin B12
Low Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 1.4 mg Folic acid: 0.0 mg Vitamin B12: 2.0 mcg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg
|
|---|---|---|
|
CVD Death
|
75 participants
|
91 participants
|
SECONDARY outcome
Timeframe: Up to 6 years (mean 4 years)censored at 3 months after return to dialysis
Outcome measures
| Measure |
High Dose Multivitamin
n=2056 Participants
Multivitamin with increased folic acid, vitamin B6 and vitamin B12
High Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 50 mg Folic acid: 5.0 mg Vitamin B12: 1.0 mg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg
|
Low Dose Multivitamin
n=2054 Participants
Multivitamin devoid of folic acid and with EAR amounts of vitamin B6 and vitamin B12
Low Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 1.4 mg Folic acid: 0.0 mg Vitamin B12: 2.0 mcg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg
|
|---|---|---|
|
Coronary Artery Revascularization
|
111 participants
|
120 participants
|
SECONDARY outcome
Timeframe: Up to 6 years (mean 4 years)censored at 3 months after return to dialysis
Outcome measures
| Measure |
High Dose Multivitamin
n=2056 Participants
Multivitamin with increased folic acid, vitamin B6 and vitamin B12
High Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 50 mg Folic acid: 5.0 mg Vitamin B12: 1.0 mg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg
|
Low Dose Multivitamin
n=2054 Participants
Multivitamin devoid of folic acid and with EAR amounts of vitamin B6 and vitamin B12
Low Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 1.4 mg Folic acid: 0.0 mg Vitamin B12: 2.0 mcg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg
|
|---|---|---|
|
Lower Extremity Peripheral Arterial Disease (PAD)
|
59 participants
|
53 participants
|
SECONDARY outcome
Timeframe: Up to 6 years (mean 4 years)censored at 3 months after return to dialysis
Outcome measures
| Measure |
High Dose Multivitamin
n=2056 Participants
Multivitamin with increased folic acid, vitamin B6 and vitamin B12
High Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 50 mg Folic acid: 5.0 mg Vitamin B12: 1.0 mg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg
|
Low Dose Multivitamin
n=2054 Participants
Multivitamin devoid of folic acid and with EAR amounts of vitamin B6 and vitamin B12
Low Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 1.4 mg Folic acid: 0.0 mg Vitamin B12: 2.0 mcg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg
|
|---|---|---|
|
Carotid Endarterectomy or Angioplasty
|
10 participants
|
9 participants
|
SECONDARY outcome
Timeframe: Up to 6 years (mean 4 years)censored at 3 months after return to dialysis
Outcome measures
| Measure |
High Dose Multivitamin
n=2056 Participants
Multivitamin with increased folic acid, vitamin B6 and vitamin B12
High Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 50 mg Folic acid: 5.0 mg Vitamin B12: 1.0 mg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg
|
Low Dose Multivitamin
n=2054 Participants
Multivitamin devoid of folic acid and with EAR amounts of vitamin B6 and vitamin B12
Low Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 1.4 mg Folic acid: 0.0 mg Vitamin B12: 2.0 mcg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg
|
|---|---|---|
|
Abdominal Aortic Aneurysm Repair
|
3 participants
|
5 participants
|
SECONDARY outcome
Timeframe: Up to 6 years (mean 4 years)censored at 3 months after return to dialysis
Outcome measures
| Measure |
High Dose Multivitamin
n=2 Participants
Multivitamin with increased folic acid, vitamin B6 and vitamin B12
High Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 50 mg Folic acid: 5.0 mg Vitamin B12: 1.0 mg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg
|
Low Dose Multivitamin
n=2054 Participants
Multivitamin devoid of folic acid and with EAR amounts of vitamin B6 and vitamin B12
Low Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 1.4 mg Folic acid: 0.0 mg Vitamin B12: 2.0 mcg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg
|
|---|---|---|
|
Renal Artery Revascularization
|
9 participants
|
7 participants
|
Adverse Events
High Dose Multivitamin
Serious events: 0 serious events
Other events: 121 other events
Deaths: 0 deaths
Low Dose Multivitamin
Serious events: 0 serious events
Other events: 114 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
High Dose Multivitamin
n=2056 participants at risk
Multivitamin with increased folic acid, vitamin B6 and vitamin B12
High Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 50 mg Folic acid: 5.0 mg Vitamin B12: 1.0 mg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg
|
Low Dose Multivitamin
n=2054 participants at risk
Multivitamin devoid of folic acid and with EAR amounts of vitamin B6 and vitamin B12
Low Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 1.4 mg Folic acid: 0.0 mg Vitamin B12: 2.0 mcg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg
|
|---|---|---|
|
Gastrointestinal disorders
Gastrointestinal disturbances
|
5.9%
121/2056 • 4 years
|
5.6%
114/2054 • 4 years
|
Additional Information
Dr. Myra Carpenter
University of North Carolina at Chapel Hill
Phone: 9199429408
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place