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Folic Acid for Vascular Outcome Reduction In Transplantation (FAVORIT) (FAVORIT)

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ClinicalTrials.gov Identifier: NCT00064753
Recruitment Status : Completed
First Posted : July 15, 2003
Results First Posted : November 26, 2015
Last Update Posted : October 18, 2017
Sponsor:
Collaborator:
Office of Dietary Supplements (ODS)
Information provided by (Responsible Party):
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Chronic Kidney Disease
Cardiovascular Disease
Death
Interventions Drug: High Dose Multivitamin
Device: Low Dose Multivitamin
Enrollment 4110
Recruitment Details Trial enrolled 4110 participants from August 2002 through January 2007 at 20 clinical sites in the US, Canada, and Brazil.
Pre-assignment Details  
Arm/Group Title High Dose Multivitamin Low Dose Multivitamin
Hide Arm/Group Description

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

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

Period Title: Overall Study
Started 2056 2054
Completed 1382 1406
Not Completed 674 648
Reason Not Completed
Death             251             242
Withdrawal by Subject             198             171
Lost to Follow-up             225             235
Arm/Group Title High Dose Multivitamin Low Dose Multivitamin Total
Hide Arm/Group Description

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

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 of all reporting groups
Overall Number of Baseline Participants 2056 2054 4110
Hide Baseline Analysis Population Description
7273 patients were screened, of whom 2056 and 2054 were randomized to high-dose and low-dose multivitamins, respectively; 34% did not meet eligibility cutpoints for tHey and Cer, and 9% were not enrolled for other reasons. Baseline characteristics were well balanced between treatment groups overall and within country.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 2056 participants 2054 participants 4110 participants
52  (9.4) 52  (9.5) 52  (9.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2056 participants 2054 participants 4110 participants
Female
767
  37.3%
761
  37.0%
1528
  37.2%
Male
1289
  62.7%
1293
  63.0%
2582
  62.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 2056 participants 2054 participants 4110 participants
Canada 249 249 498
United States 1500 1500 3000
Brazil 307 305 612
Graft vintage  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 2056 participants 2054 participants 4110 participants
6  (5.1) 5  (5.0) 5  (5.0)
History of CVD  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 2056 participants 2054 participants 4110 participants
History of CVD 406 414 820
No History of CVD 1650 1640 3290
History of diabetes mellitus  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 2056 participants 2054 participants 4110 participants
History of diabetes mellitus 813 850 1663
No history of diabetes mellitus 1243 1204 2447
Prevalent hypertension  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 2056 participants 2054 participants 4110 participants
Prevalent hypertension 1879 1899 3778
Non-prevalent hypertension 177 155 332
Body mass index  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 2056 participants 2054 participants 4110 participants
29  (6.2) 29  (6.3) 29  (6.2)
Current smoker  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 2056 participants 2054 participants 4110 participants
Current smoker 230 221 451
Not current smoker 1826 1833 3659
Total cholesterol  
Mean (Standard Deviation)
Unit of measure:  mmol/L
Number Analyzed 2056 participants 2054 participants 4110 participants
4.8  (1.2) 4.8  (1.1) 4.8  (1.1)
High-density lipoprotein cholesterol  
Mean (Standard Deviation)
Unit of measure:  mmol/L
Number Analyzed 2056 participants 2054 participants 4110 participants
1.2  (0.4) 1.2  (0.4) 1.2  (0.4)
Calculated or direct low-density lipoprotein cholesterol  
Mean (Standard Deviation)
Unit of measure:  mmol/L
Number Analyzed 2056 participants 2054 participants 4110 participants
2.6  (0.9) 2.6  (0.9) 2.6  (0.9)
Triglycerides levels  
Mean (Standard Deviation)
Unit of measure:  mmol/L
Number Analyzed 2056 participants 2054 participants 4110 participants
2.3  (2.5) 2.2  (1.6) 2.2  (2.1)
1.Primary Outcome
Title 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
Hide Description [Not Specified]
Time Frame Up to 6 years (mean 4 years)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Censored at 3 months after return to dialysis
Arm/Group Title High Dose Multivitamin Low Dose Multivitamin
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 2029 2029
Measure Type: Number
Unit of Measure: participants
269 278
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection High Dose Multivitamin, Low Dose Multivitamin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.93
Comments P was calculated with stratified proportional hazards models stratified by country
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 0.99
Confidence Interval (2-Sided) 95%
0.84 to 1.17
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Renal Graft Failure
Hide Description [Not Specified]
Time Frame Up to 6 years (mean 4 years)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat
Arm/Group Title High Dose Multivitamin Low Dose Multivitamin
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 2029 2029
Measure Type: Number
Unit of Measure: participants
181 162
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection High Dose Multivitamin, Low Dose Multivitamin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.19
Comments P was calculated with stratified proportional hazards models stratified by country
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 1.15
Confidence Interval (2-Sided) 95%
0.93 to 1.43
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Mortality (All-cause)
Hide Description censored at 3 months after return to dialysis
Time Frame Up to 6 years (mean 4 years)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title High Dose Multivitamin Low Dose Multivitamin
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 2054 2049
Measure Type: Number
Unit of Measure: participants
217 214
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection High Dose Multivitamin, Low Dose Multivitamin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.67
Comments P was calculated with stratified proportional hazards models stratified by country
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 1.04
Confidence Interval (2-Sided) 95%
0.86 to 1.26
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Fatal/Non-fatal Myocardial Infarction (MI)
Hide Description censored at 3 months after return to dialysis
Time Frame Up to 6 years (mean 4 years)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title High Dose Multivitamin Low Dose Multivitamin
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 2056 2054
Measure Type: Number
Unit of Measure: participants
90 86
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection High Dose Multivitamin, Low Dose Multivitamin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.61
Comments P was calculated with stratified proportional hazards models stratified by country
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 1.08
Confidence Interval (2-Sided) 95%
0.80 to 1.45
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Fatal/Non-fatal Stroke
Hide Description censored at 3 months after return to dialysis
Time Frame Up to 6 years (mean 4 years)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title High Dose Multivitamin Low Dose Multivitamin
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 2056 2054
Measure Type: Number
Unit of Measure: participants
35 32
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection High Dose Multivitamin, Low Dose Multivitamin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.64
Comments P was calculated with stratified proportional hazards models stratified by country
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 1.12
Confidence Interval (2-Sided) 95%
0.69 to 1.81
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Resuscitated Sudden Death (RSD)
Hide Description censored at 3 months after return to dialysis
Time Frame Up to 6 years (mean 4 years)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title High Dose Multivitamin Low Dose Multivitamin
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 2056 2054
Measure Type: Number
Unit of Measure: participants
7 9
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection High Dose Multivitamin, Low Dose Multivitamin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.66
Comments P was calculated with stratified proportional hazards models stratified by country
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 0.80
Confidence Interval (2-Sided) 95%
0.30 to 2.15
Estimation Comments [Not Specified]
7.Secondary Outcome
Title CVD Death
Hide Description censored at 3 months after return to dialysis
Time Frame Up to 6 years (mean 4 years)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
P was calculated with stratified proportional hazards models stratified by country
Arm/Group Title High Dose Multivitamin Low Dose Multivitamin
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 2056 2054
Measure Type: Number
Unit of Measure: participants
75 91
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection High Dose Multivitamin, Low Dose Multivitamin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.28
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 0.84
Confidence Interval (2-Sided) 95%
0.62 to 1.15
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Coronary Artery Revascularization
Hide Description censored at 3 months after return to dialysis
Time Frame Up to 6 years (mean 4 years)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title High Dose Multivitamin Low Dose Multivitamin
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 2056 2054
Measure Type: Number
Unit of Measure: participants
111 120
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection High Dose Multivitamin, Low Dose Multivitamin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.70
Comments [Not Specified]
Method Regression, Cox
Comments P was calculated with stratified proportional hazards models stratified by country
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 0.95
Confidence Interval (2-Sided) 95%
0.73 to 1.23
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Lower Extremity Peripheral Arterial Disease (PAD)
Hide Description censored at 3 months after return to dialysis
Time Frame Up to 6 years (mean 4 years)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title High Dose Multivitamin Low Dose Multivitamin
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 2056 2054
Measure Type: Number
Unit of Measure: participants
59 53
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection High Dose Multivitamin, Low Dose Multivitamin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.49
Comments [Not Specified]
Method Regression, Cox
Comments P was calculated with stratified proportional hazards models stratified by country
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 1.14
Confidence Interval (2-Sided) 95%
0.79 to 1.65
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Carotid Endarterectomy or Angioplasty
Hide Description censored at 3 months after return to dialysis
Time Frame Up to 6 years (mean 4 years)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title High Dose Multivitamin Low Dose Multivitamin
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 2056 2054
Measure Type: Number
Unit of Measure: participants
10 9
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection High Dose Multivitamin, Low Dose Multivitamin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.78
Comments [Not Specified]
Method Regression, Cox
Comments P was calculated with stratified proportional hazards models stratified by country
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 1.14
Confidence Interval (2-Sided) 95%
0.46 to 2.80
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Abdominal Aortic Aneurysm Repair
Hide Description censored at 3 months after return to dialysis
Time Frame Up to 6 years (mean 4 years)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title High Dose Multivitamin Low Dose Multivitamin
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 2056 2054
Measure Type: Number
Unit of Measure: participants
3 5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection High Dose Multivitamin, Low Dose Multivitamin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.50
Comments [Not Specified]
Method Regression, Cox
Comments P was calculated with stratified proportional hazards models stratified by country
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 0.61
Confidence Interval (2-Sided) 95%
0.15 to 2.57
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Renal Artery Revascularization
Hide Description censored at 3 months after return to dialysis
Time Frame Up to 6 years (mean 4 years)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title High Dose Multivitamin Low Dose Multivitamin
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 2 2054
Measure Type: Number
Unit of Measure: participants
9 7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection High Dose Multivitamin, Low Dose Multivitamin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.60
Comments [Not Specified]
Method Regression, Cox
Comments P was calculated with stratified proportional hazards models stratified by country
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 1.30
Confidence Interval (2-Sided) 95%
0.48 to 3.50
Estimation Comments [Not Specified]
Time Frame 4 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title High Dose Multivitamin Low Dose Multivitamin
Hide Arm/Group Description

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

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

All-Cause Mortality
High Dose Multivitamin Low Dose Multivitamin
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
High Dose Multivitamin Low Dose Multivitamin
Affected / at Risk (%) Affected / at Risk (%)
Total   0/2056 (0.00%)   0/2054 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
High Dose Multivitamin Low Dose Multivitamin
Affected / at Risk (%) Affected / at Risk (%)
Total   121/2056 (5.89%)   114/2054 (5.55%) 
Gastrointestinal disorders     
Gastrointestinal disturbances *  121/2056 (5.89%)  114/2054 (5.55%) 
*
Indicates events were collected by non-systematic assessment
The B-vitamin pathway for reducing total homocysteine (tHcy) may not be the optimal one for reducing CVD risk. Also, the duration of follow-up may not have been sufficient to identify a lagged impact on modification of CVD risk.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Myra Carpenter
Organization: University of North Carolina at Chapel Hill
Phone: 9199429408
Other Publications:
Responsible Party: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT00064753     History of Changes
Other Study ID Numbers: FAVORIT dk61700 IND
U01DK061700 ( U.S. NIH Grant/Contract )
First Submitted: July 11, 2003
First Posted: July 15, 2003
Results First Submitted: October 26, 2015
Results First Posted: November 26, 2015
Last Update Posted: October 18, 2017