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CompletedNCT00064753FAVORITUpdated Oct 18, 2017Results posted

Folic Acid for Vascular Outcome Reduction In Transplantation (FAVORIT)

A Phase 2/3 interventional study of High Dose Multivitamin and Low Dose Multivitamin in Chronic Kidney Disease, Cardiovascular Disease and Death, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). Completed at 30 sites in 3 countries. Open to participants aged 35 Years to 75 Years. Per ClinicalTrials.gov, last updated 2017-10-18.

Sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · Phase 2/3, Interventional, and Treatment

Phase
Phase 2/3
Study type
Interventional
Enrollment
4,110
Allocation
Randomized
Ages
35 Years to 75 Years
Sex
All
01

Study summary

The purpose of this randomized clinical trial is to determine if lowering homocysteine levels in renal transplant recipients with a multivitamin will reduce the occurrence of cardiovascular disease outcomes.

Read the detailed description

The hypothesis of the trial is as follows: Treatment with a high dose combination of folic acid, vitamin B6, and vitamin B12 will reduce the rate of pooled arteriosclerotic cardiovascular disease outcomes (i.e., pooled occurrence of non-fatal and fatal arteriosclerotic outcomes, including coronary heart, cerebrovascular, and peripheral vascular disease events) relative to treatment with an identical multivitamin containing no folic acid, and Estimated Average Requirement amounts of vitamin B6, vitamin B12, among chronic, stable renal transplant recipients

02

Conditions studied

  • Chronic Kidney Disease
  • Cardiovascular Disease
  • Death

Keywords

  • homocysteine
  • multi-vitamin
  • cardiovascular disease
  • renal transplant recipients
03

In context

Renal Insufficiency, Chronic

3,224 studies on the registry are indexed under Renal Insufficiency, Chronic; 706 are open to participants now.

This study's enrollment of 4,110 is above the median of 74 across 2,229 interventional studies indexed under Renal Insufficiency, Chronic.

Browse Renal Insufficiency, Chronic studies →

Lead sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) is the lead sponsor of 537 studies on the registry; 54 are open to participants now.

Of its 80 completed or terminated interventional studies of FDA-regulated products, 51 (64%) have results posted.

Browse National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
35 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 35 - 75 years old
  • Had kidney transplant at least 6 months
  • Calculated Creatinine Clearance must be 25 mL/min or greater
  • Must be willing to stop supplements (B6, B12, folic acid) for 4-6 weeks prior to visit

Exclusion criteria

Exclusion Criteria:

  • If pregnant or lactating
  • If of child bearing potential and not on birth control

  • If any of the following will limit life expectancy to less than 2 yrs:

    • Cancer
    • Congestive heart failure (CHF) (end stage)
    • Liver disease (end stage)
    • Severe pulmonary disease
    • Progressive HIV
    • Any other chronic wasting illness
  • If patient had myocardial infarction (MI), stroke, lower extremity amputation above ankle or percutaneous revascularization procedure (coronary, cerebrovascular, lower extremity) in past 2months
  • If patient had coronary artery bypass graft (CABG) or abdominal aortic aneurysm (AAA) in past 5 months
  • If patient has conditions that prevent reliable study participation e.g., depression, alcohol or drug abuse, other cardiovascular disease (CVD) studies
  • If patient has had multi-organ transplant, except kidney/pancreas
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
4,110 participants (actual)

Study arms

  • Experimental
    High Dose Multivitamin

    Multivitamin with increased folic acid, vitamin B6 and vitamin B12

    Drug: High Dose Multivitamin

  • Active comparator
    Low Dose Multivitamin

    Multivitamin devoid of folic acid and with estimated average requirement amounts of vitamin B6 and vitamin B12

    Device: Low Dose Multivitamin

Interventions

  • DrugHigh 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

    Also known as: multivitamin

  • DeviceLow 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

    Also known as: multivitamin

06

What researchers measure

Primary outcomes

  1. 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: Up to 6 years (mean 4 years)

Secondary outcomes

  1. Renal Graft Failure

    Time frame: Up to 6 years (mean 4 years)

  2. Mortality (All-cause)

    censored at 3 months after return to dialysis

    Time frame: Up to 6 years (mean 4 years)

  3. Fatal/Non-fatal Myocardial Infarction (MI)

    censored at 3 months after return to dialysis

    Time frame: Up to 6 years (mean 4 years)

  4. Fatal/Non-fatal Stroke

    censored at 3 months after return to dialysis

    Time frame: Up to 6 years (mean 4 years)

  5. Resuscitated Sudden Death (RSD)

    censored at 3 months after return to dialysis

    Time frame: Up to 6 years (mean 4 years)

  6. CVD Death

    censored at 3 months after return to dialysis

    Time frame: Up to 6 years (mean 4 years)

  7. Coronary Artery Revascularization

    censored at 3 months after return to dialysis

    Time frame: Up to 6 years (mean 4 years)

  8. Lower Extremity Peripheral Arterial Disease (PAD)

    censored at 3 months after return to dialysis

    Time frame: Up to 6 years (mean 4 years)

  9. Carotid Endarterectomy or Angioplasty

    censored at 3 months after return to dialysis

    Time frame: Up to 6 years (mean 4 years)

  10. Abdominal Aortic Aneurysm Repair

    censored at 3 months after return to dialysis

    Time frame: Up to 6 years (mean 4 years)

  11. Renal Artery Revascularization

    censored at 3 months after return to dialysis

    Time frame: Up to 6 years (mean 4 years)

07

Results

Posted Nov 26, 2015
Limitations and caveats
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.

Participant flow

Trial enrolled 4110 participants from August 2002 through January 2007 at 20 clinical sites in the US, Canada, and Brazil.

Participant flow — Overall Study
MilestoneHigh Dose MultivitaminLow Dose Multivitamin
Started20562054
Completed13821406
Not completed674648
Withdrew: Death251242
Withdrew: Withdrawal by subject198171
Withdrew: Lost to follow-up225235

Outcome measures

PrimaryRecurrent 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:
Up to 6 years (mean 4 years)
Reported as:
Number · participants
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
participantsHigh Dose MultivitaminLow Dose Multivitamin
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 Events269278
Statistical analysis
  • High Dose Multivitamin vs Low Dose Multivitamin · Regression, Cox · p = 0.93 (P was calculated with stratified proportional hazards models stratified by country) · Cox proportional hazard: 0.99 · 95% CI 0.84 to 1.17
SecondaryRenal Graft Failure
Time frame:
Up to 6 years (mean 4 years)
Reported as:
Number · participants
Renal Graft Failure
participantsHigh Dose MultivitaminLow Dose Multivitamin
Renal Graft Failure181162
Statistical analysis
  • High Dose Multivitamin vs Low Dose Multivitamin · Regression, Cox · p = 0.19 (P was calculated with stratified proportional hazards models stratified by country) · Cox proportional hazard: 1.15 · 95% CI 0.93 to 1.43
SecondaryMortality (All-cause)

censored at 3 months after return to dialysis

Time frame:
Up to 6 years (mean 4 years)
Reported as:
Number · participants
Mortality (All-cause)
participantsHigh Dose MultivitaminLow Dose Multivitamin
Mortality (All-cause)217214
Statistical analysis
  • High Dose Multivitamin vs Low Dose Multivitamin · Regression, Cox · p = 0.67 (P was calculated with stratified proportional hazards models stratified by country) · Cox proportional hazard: 1.04 · 95% CI 0.86 to 1.26
SecondaryFatal/Non-fatal Myocardial Infarction (MI)

censored at 3 months after return to dialysis

Time frame:
Up to 6 years (mean 4 years)
Reported as:
Number · participants
Fatal/Non-fatal Myocardial Infarction (MI)
participantsHigh Dose MultivitaminLow Dose Multivitamin
Fatal/Non-fatal Myocardial Infarction (MI)9086
Statistical analysis
  • High Dose Multivitamin vs Low Dose Multivitamin · Regression, Cox · p = 0.61 (P was calculated with stratified proportional hazards models stratified by country) · Cox proportional hazard: 1.08 · 95% CI 0.80 to 1.45
SecondaryFatal/Non-fatal Stroke

censored at 3 months after return to dialysis

Time frame:
Up to 6 years (mean 4 years)
Reported as:
Number · participants
Fatal/Non-fatal Stroke
participantsHigh Dose MultivitaminLow Dose Multivitamin
Fatal/Non-fatal Stroke3532
Statistical analysis
  • High Dose Multivitamin vs Low Dose Multivitamin · Regression, Cox · p = 0.64 (P was calculated with stratified proportional hazards models stratified by country) · Cox proportional hazard: 1.12 · 95% CI 0.69 to 1.81
SecondaryResuscitated Sudden Death (RSD)

censored at 3 months after return to dialysis

Time frame:
Up to 6 years (mean 4 years)
Reported as:
Number · participants
Resuscitated Sudden Death (RSD)
participantsHigh Dose MultivitaminLow Dose Multivitamin
Resuscitated Sudden Death (RSD)79
Statistical analysis
  • High Dose Multivitamin vs Low Dose Multivitamin · Regression, Cox · p = 0.66 (P was calculated with stratified proportional hazards models stratified by country) · Cox proportional hazard: 0.80 · 95% CI 0.30 to 2.15
SecondaryCVD Death

censored at 3 months after return to dialysis

Time frame:
Up to 6 years (mean 4 years)
Reported as:
Number · participants
CVD Death
participantsHigh Dose MultivitaminLow Dose Multivitamin
CVD Death7591
Statistical analysis
  • High Dose Multivitamin vs Low Dose Multivitamin · Regression, Cox · p = 0.28 · Cox proportional hazard: 0.84 · 95% CI 0.62 to 1.15
SecondaryCoronary Artery Revascularization

censored at 3 months after return to dialysis

Time frame:
Up to 6 years (mean 4 years)
Reported as:
Number · participants
Coronary Artery Revascularization
participantsHigh Dose MultivitaminLow Dose Multivitamin
Coronary Artery Revascularization111120
Statistical analysis
  • High Dose Multivitamin vs Low Dose Multivitamin · Regression, Cox · p = 0.70 · Cox proportional hazard: 0.95 · 95% CI 0.73 to 1.23P was calculated with stratified proportional hazards models stratified by country
SecondaryLower Extremity Peripheral Arterial Disease (PAD)

censored at 3 months after return to dialysis

Time frame:
Up to 6 years (mean 4 years)
Reported as:
Number · participants
Lower Extremity Peripheral Arterial Disease (PAD)
participantsHigh Dose MultivitaminLow Dose Multivitamin
Lower Extremity Peripheral Arterial Disease (PAD)5953
Statistical analysis
  • High Dose Multivitamin vs Low Dose Multivitamin · Regression, Cox · p = 0.49 · Cox proportional hazard: 1.14 · 95% CI 0.79 to 1.65P was calculated with stratified proportional hazards models stratified by country
SecondaryCarotid Endarterectomy or Angioplasty

censored at 3 months after return to dialysis

Time frame:
Up to 6 years (mean 4 years)
Reported as:
Number · participants
Carotid Endarterectomy or Angioplasty
participantsHigh Dose MultivitaminLow Dose Multivitamin
Carotid Endarterectomy or Angioplasty109
Statistical analysis
  • High Dose Multivitamin vs Low Dose Multivitamin · Regression, Cox · p = 0.78 · Cox proportional hazard: 1.14 · 95% CI 0.46 to 2.80P was calculated with stratified proportional hazards models stratified by country
SecondaryAbdominal Aortic Aneurysm Repair

censored at 3 months after return to dialysis

Time frame:
Up to 6 years (mean 4 years)
Reported as:
Number · participants
Abdominal Aortic Aneurysm Repair
participantsHigh Dose MultivitaminLow Dose Multivitamin
Abdominal Aortic Aneurysm Repair35
Statistical analysis
  • High Dose Multivitamin vs Low Dose Multivitamin · Regression, Cox · p = 0.50 · Cox proportional hazard: 0.61 · 95% CI 0.15 to 2.57P was calculated with stratified proportional hazards models stratified by country
SecondaryRenal Artery Revascularization

censored at 3 months after return to dialysis

Time frame:
Up to 6 years (mean 4 years)
Reported as:
Number · participants
Renal Artery Revascularization
participantsHigh Dose MultivitaminLow Dose Multivitamin
Renal Artery Revascularization97
Statistical analysis
  • High Dose Multivitamin vs Low Dose Multivitamin · Regression, Cox · p = 0.60 · Cox proportional hazard: 1.30 · 95% CI 0.48 to 3.50P was calculated with stratified proportional hazards models stratified by country

Adverse events

Collected over 4 years. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
High Dose Multivitamin—0/2,056 (0%)121/2,056 (5.9%)
Low Dose Multivitamin—0/2,054 (0%)114/2,054 (5.6%)
Most frequent other events
Most frequent other events
EventHigh Dose MultivitaminLow Dose Multivitamin
Gastrointestinal disturbancesGastrointestinal disorders121/2056114/2054

Baseline characteristics

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
Age, Continuous(years)High Dose MultivitaminLow Dose MultivitaminTotal
Mean52 ± 9.452 ± 9.552 ± 9.4
Sex: Female, Male
Sex: Female, Male(Participants)High Dose MultivitaminLow Dose MultivitaminTotal
Female7677611528
Male128912932582
Region of Enrollment
Region of Enrollment(participants)High Dose MultivitaminLow Dose MultivitaminTotal
Canada249249498
United States150015003000
Brazil307305612
Graft vintage
Graft vintage(years)High Dose MultivitaminLow Dose MultivitaminTotal
Mean6 ± 5.15 ± 5.05 ± 5.0
History of CVD
History of CVD(participants)High Dose MultivitaminLow Dose MultivitaminTotal
History of CVD406414820
No History of CVD165016403290
History of diabetes mellitus
History of diabetes mellitus(participants)High Dose MultivitaminLow Dose MultivitaminTotal
History of diabetes mellitus8138501663
No history of diabetes mellitus124312042447
Prevalent hypertension
Prevalent hypertension(participants)High Dose MultivitaminLow Dose MultivitaminTotal
Prevalent hypertension187918993778
Non-prevalent hypertension177155332
Body mass index
Body mass index(kg/m^2)High Dose MultivitaminLow Dose MultivitaminTotal
Mean29 ± 6.229 ± 6.329 ± 6.2

5 further baseline measures are reported on the registry.

08

Study locations

30 sites
  • University of Alabama at Birmingham School of Medicine
    Birmingham, Alabama 35233, United States
  • Banner Good Samaritan Transplant
    Phoenix, Arizona 85004-1608, United States
  • Cedars-Sinai Health System/Center for Kidney Diseases and Transplantation
    Los Angeles, California 90048, United States
  • University of California at Los Angeles
    Los Angeles, California 90095-7306, United States
  • University of California at San Francisco
    San Francisco, California 94143-0780, United States
  • Northwestern University
    Chicago, Illinois 60611, United States
  • Southern Illinois University
    Springfield, Illinois 62794-9638, United States
  • Indiana University
    Indianapolis, Indiana 46202, United States
  • University of Iowa Hospitals and Clinics
    Iowa City, Iowa 52242, United States
  • Maine Medical Center
    Portland, Maine 04102, United States
  • University of Maryland Medical Center
    Baltimore, Maryland 21201, United States
  • Brigham and Women's Hospital
    Boston, Massachusetts 02120, United States
  • University of Michigan Medical Center
    Ann Arbor, Michigan 48109-0364, United States
  • Hennepin County Medical Center
    Minneapolis, Minnesota 55404, United States
  • Faireview University Medical Center
    Minneapolis, Minnesota 55455, United States
  • Mayo Clinic
    Rochester, Minnesota 55905, United States
  • Washington University
    St Louis, Missouri 63110, United States
  • Albany Medical Center
    Albany, New York 12208, United States
  • State University of New York Downstate Medical Center
    Brooklyn, New York 11203, United States
  • Duke University Medical Center
    Durham, North Carolina 27710, United States
  • East Carolina University
    Greenville, North Carolina 27834, United States
  • The Ohio State University Medical Center
    Columbus, Ohio 43210-1228, United States
  • Oregon Health Sciences University
    Portland, Oregon 97201-2940, United States
  • Drexel University
    Philadelphia, Pennsylvania 19102-1192, United States
  • Rhode Island Hospital
    Providence, Rhode Island 02903, United States
  • University of Wisconsin at Madison
    Madison, Wisconsin 53792, United States
  • Medical College of Wisconsin
    Milwaukee, Wisconsin 53226, United States
  • Universidade Federal de Sao Paulo
    São Paulo, São Paulo 04023-900, Brazil
  • London Health Sciences Center
    London, Ontario N6A 5A5, Canada
  • Toronto General Hospital
    Toronto, Ontario M5G 2N2, Canada
09

References and documents

Publications

  • Weiner DE, Carpenter MA, Levey AS, Ivanova A, Cole EH, Hunsicker L, Kasiske BL, Kim SJ, Kusek JW, Bostom AG. Kidney function and risk of cardiovascular disease and mortality in kidney transplant recipients: the FAVORIT trial. Am J Transplant. 2012 Sep;12(9):2437-45. doi: 10.1111/j.1600-6143.2012.04101.x. Epub 2012 May 17. PubMed 22594581 ↗
  • Troen AM, Scott TM, D'Anci KE, Moorthy D, Dobson B, Rogers G, Weiner DE, Levey AS, Dallal GE, Jacques PF, Selhub J, Rosenberg IH; FACT Study Investigators. Cognitive dysfunction and depression in adult kidney transplant recipients: baseline findings from the FAVORIT Ancillary Cognitive Trial (FACT). J Ren Nutr. 2012 Mar;22(2):268-276.e3. doi: 10.1053/j.jrn.2011.07.009. Epub 2011 Dec 6. PubMed 22153382 ↗
  • Carpenter MA, Weir MR, Adey DB, House AA, Bostom AG, Kusek JW. Inadequacy of cardiovascular risk factor management in chronic kidney transplantation - evidence from the FAVORIT study. Clin Transplant. 2012 Jul-Aug;26(4):E438-46. doi: 10.1111/j.1399-0012.2012.01676.x. Epub 2012 Jul 9. PubMed 22775763 ↗
  • Bostom AG, Carpenter MA, Kusek JW, Hunsicker LG, Pfeffer MA, Levey AS, Jacques PF, McKenney J; FAVORIT Investigators. Rationale and design of the Folic Acid for Vascular Outcome Reduction In Transplantation (FAVORIT) trial. Am Heart J. 2006 Sep;152(3):448.e1-7. doi: 10.1016/j.ahj.2006.03.004. PubMed 16923411 ↗
  • Weir MR, Gravens-Muller L, Costa N, Ivanova A, Manitpisitkul W, Bostom AG, Diamantidis CJ; FAVORIT Study Investigators. Safety events in kidney transplant recipients: results from the folic Acid for vascular outcome reduction in transplant trial. Transplantation. 2015 May;99(5):1003-8. doi: 10.1097/TP.0000000000000454. PubMed 25393158 ↗
  • Carpenter MA, John A, Weir MR, Smith SR, Hunsicker L, Kasiske BL, Kusek JW, Bostom A, Ivanova A, Levey AS, Solomon S, Pesavento T, Weiner DE. BP, cardiovascular disease, and death in the Folic Acid for Vascular Outcome Reduction in Transplantation trial. J Am Soc Nephrol. 2014 Jul;25(7):1554-62. doi: 10.1681/ASN.2013040435. Epub 2014 Mar 13. PubMed 24627349 ↗
  • Bostom AG, Carpenter MA, Hunsicker L, Jacques PF, Kusek JW, Levey AS, McKenney JL, Mercier RY, Pfeffer MA, Selhub J; FAVORIT Study Investigators. Baseline characteristics of participants in the Folic Acid for Vascular Outcome Reduction in Transplantation (FAVORIT) Trial. Am J Kidney Dis. 2009 Jan;53(1):121-8. doi: 10.1053/j.ajkd.2008.08.010. Epub 2008 Nov 20. PubMed 19022547 ↗
  • Bostom AG, Carpenter MA, Kusek JW, Levey AS, Hunsicker L, Pfeffer MA, Selhub J, Jacques PF, Cole E, Gravens-Mueller L, House AA, Kew C, McKenney JL, Pacheco-Silva A, Pesavento T, Pirsch J, Smith S, Solomon S, Weir M. Homocysteine-lowering and cardiovascular disease outcomes in kidney transplant recipients: primary results from the Folic Acid for Vascular Outcome Reduction in Transplantation trial. Circulation. 2011 Apr 26;123(16):1763-70. doi: 10.1161/CIRCULATIONAHA.110.000588. Epub 2011 Apr 11. PubMed 21482964 ↗
  • Kang AW, Garber CE, Eaton CB, Risica PM, Bostom AG. Physical Activity and Cardiovascular Risk among Kidney Transplant Patients. Med Sci Sports Exerc. 2019 Jun;51(6):1154-1161. doi: 10.1249/MSS.0000000000001886. PubMed 30629045 ↗
  • Weinrauch LA, Claggett B, Liu J, Finn PV, Weir MR, Weiner DE, D'Elia JA. Smoking and outcomes in kidney transplant recipients: a post hoc survival analysis of the FAVORIT trial. Int J Nephrol Renovasc Dis. 2018 Apr 27;11:155-164. doi: 10.2147/IJNRD.S161001. eCollection 2018. PubMed 29760559 ↗
  • Weinrauch LA, D'Elia JA, Weir MR, Bunnapradist S, Finn PV, Liu J, Claggett B, Monaco AP. Infection and Malignancy Outweigh Cardiovascular Mortality in Kidney Transplant Recipients: Post Hoc Analysis of the FAVORIT Trial. Am J Med. 2018 Feb;131(2):165-172. doi: 10.1016/j.amjmed.2017.08.038. Epub 2017 Sep 21. PubMed 28943384 ↗

Individual participant data

Plan to share: Yes — Individual patient data and samples are available at the NIDDK Central repository

Supporting information: Study protocol, Statistical analysis plan, Clinical study report

Time frame: December 2013

Data sharing details ↗ · www.niddkrepository.org

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 18, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00064753
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborators
Office of Dietary Supplements (ODS)
Responsible party
Sponsor
First posted
Jul 15, 2003
Start date
May 2002
Primary completion
Oct 2011
Completion
Oct 2011
Results posted
Nov 26, 2015
Last update
Oct 18, 2017

Study contacts

Andrew Levey, M.D.
study director · Tufts Medical Center
Myra A Carpenter, PhD
principal investigator · University of North Carolina, Chapel Hill

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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