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

This study has been completed.
Sponsor:
Collaborator:
Office of Dietary Supplements (ODS)
Information provided by (Responsible Party):
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00064753
First received: July 11, 2003
Last updated: October 26, 2015
Last verified: October 2015
Results First Received: October 26, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Chronic Kidney Disease
Cardiovascular Disease
Death
Interventions: Drug: High Dose Multivitamin
Device: Low Dose Multivitamin

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Trial enrolled 4110 participants from August 2002 through January 2007 at 20 clinical sites in the US, Canada, and Brazil.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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 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


Participant Flow:   Overall Study
    High Dose Multivitamin     Low Dose Multivitamin  
STARTED     2056     2054  
COMPLETED     1382     1406  
NOT COMPLETED     674     648  
Death                 251                 242  
Withdrawal by Subject                 198                 171  
Lost to Follow-up                 225                 235  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
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 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 Total of all reporting groups

Baseline Measures
    High Dose Multivitamin     Low Dose Multivitamin     Total  
Number of Participants  
[units: participants]
  2056     2054     4110  
Age  
[units: years]
Mean (Standard Deviation)
  52  (9.4)     52  (9.5)     52  (9.4)  
Gender  
[units: participants]
     
Female     767     761     1528  
Male     1289     1293     2582  
Region of Enrollment  
[units: participants]
     
Canada     249     249     498  
United States     1500     1500     3000  
Brazil     307     305     612  
Graft vintage  
[units: years]
Mean (Standard Deviation)
  6  (5.1)     5  (5.0)     5  (5.0)  
History of CVD  
[units: participants]
     
History of CVD     406     414     820  
No History of CVD     1650     1640     3290  
History of diabetes mellitus  
[units: participants]
     
History of diabetes mellitus     813     850     1663  
No history of diabetes mellitus     1243     1204     2447  
Prevalent hypertension  
[units: participants]
     
Prevalent hypertension     1879     1899     3778  
Non-prevalent hypertension     177     155     332  
Body mass index  
[units: kg/m^2]
Mean (Standard Deviation)
  29  (6.2)     29  (6.3)     29  (6.2)  
Current smoker  
[units: participants]
     
Current smoker     230     221     451  
Not current smoker     1826     1833     3659  
Total cholesterol  
[units: mmol/L]
Mean (Standard Deviation)
  4.8  (1.2)     4.8  (1.1)     4.8  (1.1)  
High-density lipoprotein cholesterol  
[units: mmol/L]
Mean (Standard Deviation)
  1.2  (0.4)     1.2  (0.4)     1.2  (0.4)  
Calculated or direct low-density lipoprotein cholesterol  
[units: mmol/L]
Mean (Standard Deviation)
  2.6  (0.9)     2.6  (0.9)     2.6  (0.9)  
Triglycerides levels  
[units: mmol/L]
Mean (Standard Deviation)
  2.3  (2.5)     2.2  (1.6)     2.2  (2.1)  



  Outcome Measures
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1.  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   [ Time Frame: Through July 31, 2011 (censored 3-months post graft failure) ]

2.  Secondary:   Renal Graft Failure   [ Time Frame: Through July 31, 2011 ]

3.  Secondary:   Mortality (All-cause)   [ Time Frame: Through July 31, 2011 ]

4.  Secondary:   Fatal/Non-fatal MI   [ Time Frame: Through July 31, 2011 ]

5.  Secondary:   Fatal/Non-fatal Stroke   [ Time Frame: Through July 31, 2011 ]

6.  Secondary:   RSD   [ Time Frame: Through July 31, 2011 ]

7.  Secondary:   CVD Death   [ Time Frame: Through July 31, 2011 ]

8.  Secondary:   Coronary Artery Revascularization   [ Time Frame: Through July 31, 2011 ]

9.  Secondary:   Lower Extremity PAD   [ Time Frame: Through July 31, 2011 ]

10.  Secondary:   Carotid Endarterectomy or Angioplasty   [ Time Frame: Through July 31, 2011 ]

11.  Secondary:   Abdominal Aortic Aneurysm Repair   [ Time Frame: Through July 31, 2011 ]

12.  Secondary:   Renal Artery Revascularization   [ Time Frame: Through July 31, 2011 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The B-vitamin pathway for reducing 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.


  More Information
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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
e-mail: myra_carpenter@unc.edu


Publications of Results:
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
Study First Received: July 11, 2003
Results First Received: October 26, 2015
Last Updated: October 26, 2015
Health Authority: United States: Federal Government
United States: Food and Drug Administration
United States: Institutional Review Board
Canada: Health Canada
Brazil: National Health Surveillance Agency