Trace Element Replenishment Study in Hemodialysis Patients
1 other identifier
interventional
150
1 country
2
Brief Summary
A pilot randomized trial that compares a new renal nutritional supplement with the standard renal vitamin. The primary objective is to compare two doses (medium and high) of the new supplement with the renal vitamin currently being prescribed to people with End Stage Renal Disease (ESRD). Secondary objective is to demonstrate the feasibility of recruitment for a definitive larger trial.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Nov 2012
Shorter than P25 for phase_3
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 23, 2011
CompletedFirst Posted
Study publicly available on registry
November 17, 2011
CompletedStudy Start
First participant enrolled
November 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2014
CompletedDecember 16, 2016
December 1, 2016
1.1 years
September 23, 2011
December 14, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Proportion of participants with zinc deficiency
Proportion of participants with zinc deficiency in the combined experimental arms compared to the proportion of participants with zinc deficiency in the active comparator arm.
90 days following baseline
Secondary Outcomes (4)
Proportion of participants with zinc deficiency
180 days following baseline
Proportion of participants with selenium deficiency
90 days and 180 days following baseline
Zinc
90 days and 180 days following baseline
Selenium
90 days and 180 days following baseline
Other Outcomes (4)
Proportions of participants with serious adverse events
30 days following last day of intervention
Proportion of participants with adverse events
30 days following last day of intervention
Change in interdialytic weight
90 days and 180 days following baseline
- +1 more other outcomes
Study Arms (3)
Low dose
EXPERIMENTALStandard renal vitamin plus low dose zinc and selenium plus vitamin E 1 capsule p.o, daily
Medium dose
EXPERIMENTALStandard renal vitamin plus medium doses of zinc and selenium plus vitamin E 1 capsule p.o, daily
Standard treatment
ACTIVE COMPARATORStandard renal vitamin 1 capsule p.o, daily
Interventions
1. ZINC 25mg (AS ZINC SULFATE) 2. SELENIUM 50 mcg (AS SODIUM SELENITE) 3. VITAMIN E (D-ALPHA-TOCOPHEROL) (AS SUCCINATE) 250 IU
1. BIOTIN 300 MCG 2. D-PANTOTHENIC ACID (CALCIUM D-PANTOTHENATE) 10 MG 3. FOLIC ACID 1 MG 4. NIACINAMIDE 20 MG 5. VITAMIN B1 (THIAMINE MONONITRATE) 1.5 MG 6. VITAMIN B12(CYANOCOBALAMIN) 6 MCG 7. VITAMIN B2 (RIBOFLAVIN) 1.7 MG 8. VITAMIN B6 (PYRIDOXINE HYDROCHLORIDE) 10 MG 9. VITAMIN C (ASCORBIC ACID) 100 MG 10. INERT FILLER (CORNSTARCH)
1. ZINC 50 mg (AS ZINC SULFATE) 2. SELENIUM 75 mcg (AS SODIUM SELENITE) 3. VITAMIN E (D-ALPHA-TOCOPHEROL) (AS SUCCINATE) 250 IU
Eligibility Criteria
You may qualify if:
- Stable on hemodialysis for 3 to 36 months
- Age greater or equal to 18 years
- Receiving Replavite or equivalent renal vitamin at baseline
- Receiving 3 dialysis treatments per week
You may not qualify if:
- Pregnant (sexually active pre-menopausal females must have negative serum pregnancy test at baseline)
- Pregnancy, kidney transplantation, a dialysis modality switch, or gastrointestinal surgery planned within 6 months
- Known allergy to corn starch
- Known allergy to zinc, selenium, vitamin E or renal vitamin.
- Projected life expectancy of \<6 months
- Any other conditions or procedures that, in the opinion of the investigator, would impede absorption of the study product.
- Participants already taking a vitamin E, zinc or selenium supplement (alone or included in another multi-vitamin).
- Individuals with a history of head or neck cancer in the past 5 years.
- Ostomy or short gut syndrome.
- Enroll in another (interventional) trial.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Marcello Tonellilead
- Alberta Health servicescollaborator
Study Sites (2)
University of Calgary
Calgary, Alberta, T2N 1N4, Canada
University of Alberta
Edmonton, Alberta, T6G 2V2, Canada
Related Publications (2)
Tonelli M, Wiebe N, Thompson S, Kinniburgh D, Klarenbach SW, Walsh M, Bello AK, Faruque L, Field C, Manns BJ, Hemmelgarn BR; Alberta Kidney Disease Network. Trace element supplementation in hemodialysis patients: a randomized controlled trial. BMC Nephrol. 2015 Apr 11;16:52. doi: 10.1186/s12882-015-0042-4.
PMID: 25884981RESULTColombijn JM, Hooft L, Jun M, Webster AC, Bots ML, Verhaar MC, Vernooij RW. Antioxidants for adults with chronic kidney disease. Cochrane Database Syst Rev. 2023 Nov 2;11(11):CD008176. doi: 10.1002/14651858.CD008176.pub3.
PMID: 37916745DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marcello A Tonelli, MD
University of Alberta
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- MD, Professor
Study Record Dates
First Submitted
September 23, 2011
First Posted
November 17, 2011
Study Start
November 1, 2012
Primary Completion
December 1, 2013
Study Completion
January 1, 2014
Last Updated
December 16, 2016
Record last verified: 2016-12
Data Sharing
- IPD Sharing
- Will not share