| Primary | 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 | | Censored at 3 months after return to dialysis | Posted | | Number | | participants | | Up to 6 years (mean 4 years) | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | Low Dose Multivitamin | 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 |
| | | Title | Denominators | Categories |
|---|
| | |
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | Regression, Cox | | 0.93 | P was calculated with stratified proportional hazards models stratified by country | Cox Proportional Hazard | 0.99 | | | 2-Sided | 95 | 0.84 | 1.17 | | | | | Superiority or Other | | |
|
| Secondary | Renal Graft Failure | | | Posted | | Number | | participants | | Up to 6 years (mean 4 years) | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | Low Dose Multivitamin | 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 |
| |
| Secondary | Mortality (All-cause) | censored at 3 months after return to dialysis | | Posted | | Number | | participants | | Up to 6 years (mean 4 years) | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | Low Dose Multivitamin | 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 |
| |
| Secondary | Fatal/Non-fatal Myocardial Infarction (MI) | censored at 3 months after return to dialysis | | Posted | | Number | | participants | | Up to 6 years (mean 4 years) | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | Low Dose Multivitamin | 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 |
| |
| Secondary | Fatal/Non-fatal Stroke | censored at 3 months after return to dialysis | | Posted | | Number | | participants | | Up to 6 years (mean 4 years) | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | Low Dose Multivitamin | 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 |
| |
| Secondary | Resuscitated Sudden Death (RSD) | censored at 3 months after return to dialysis | | Posted | | Number | | participants | | Up to 6 years (mean 4 years) | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | Low Dose Multivitamin | 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 |
| |
| Secondary | CVD Death | censored at 3 months after return to dialysis | P was calculated with stratified proportional hazards models stratified by country | Posted | | Number | | participants | | Up to 6 years (mean 4 years) | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | Low Dose Multivitamin | 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 |
| |
| Secondary | Coronary Artery Revascularization | censored at 3 months after return to dialysis | | Posted | | Number | | participants | | Up to 6 years (mean 4 years) | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | Low Dose Multivitamin | 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 |
| |
| Secondary | Lower Extremity Peripheral Arterial Disease (PAD) | censored at 3 months after return to dialysis | | Posted | | Number | | participants | | Up to 6 years (mean 4 years) | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | Low Dose Multivitamin | 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 |
| |
| Secondary | Carotid Endarterectomy or Angioplasty | censored at 3 months after return to dialysis | | Posted | | Number | | participants | | Up to 6 years (mean 4 years) | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | Low Dose Multivitamin | 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 |
| |
| Secondary | Abdominal Aortic Aneurysm Repair | censored at 3 months after return to dialysis | | Posted | | Number | | participants | | Up to 6 years (mean 4 years) | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | Low Dose Multivitamin | 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 |
| |
| Secondary | Renal Artery Revascularization | censored at 3 months after return to dialysis | | Posted | | Number | | participants | | Up to 6 years (mean 4 years) | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | Low Dose Multivitamin | 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 |
| |