End Stage Renal DiseasePhase 3NCT01473914
Trace Element Replenishment Study in Hemodialysis Patients
A Phase 3 study testing Low dose: supplemental zinc, selenium and vitamin E, Standard renal vitamin: B and C renal vitamin and Medium dose: supplemental zinc, selenium and vitamin E in people with End Stage Renal Disease, run by Marcello Tonelli at 2 sites in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease
- What is being tested?
- Low dose: supplemental zinc, selenium and vitamin E, Standard renal vitamin: B and C renal vitamin and Medium dose: supplemental zinc, selenium and vitamin E
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 2 sitesCanada
- Study dates
- Nov 2012to Jan 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
University of Calgary
Calgary, Alberta, T2N 1N4
University of Alberta
Edmonton, Alberta, T6G 2V2
About this study
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.
Read the detailed description
People with severe kidney disease follow a restricted diet aimed at reducing intake of sodium, potassium and phosphate. These dietary restrictions require reducing their intake of many fresh fruits and vegetables, which may lead to nutritional deficiency. Although the potential for malnutrition in people with kidney disease is well recognized, blood levels of most vitamins and trace elements are rarely measured. Instead, most North Americans with severe kidney disease are routinely prescribed a "renal vitamin" such as Replavite which contains a mixture of B and C vitamins.
Recent evidence (including our work; see http://www.biomedcentral.com/bmcmed/subjects/nephrology) indicates that people with severe kidney disease are often deficient in several other biologically essential substances (selenium, zinc) that are readily amenable to supplementation. Pilot data from the Northern Alberta Renal Program (NARP) indicate that approximately 90% of patients have zinc levels below the lower limit of normal; findings for selenium are similar.
Potential benefits of zinc supplementation include improvements in immune function, taste sensitivity (perhaps reducing dietary sodium intake), and improved appetite. Potential benefits of selenium supplementation include reductions in the risk of vascular disease and infection. Supplementation with vitamin E was shown in a randomized trial to reduce serious cardiovascular morbidity in people with kidney failure, but is not routinely used in dialysis patients. This suggests that supplementation of zinc, selenium, and vitamin E has theoretical benefits in kidney failure. Since patients with kidney failure already take many medications, it is logical to combine any new nutritional supplements with the ingredients of the standard renal vitamin to reduce pill burden.
This protocol concerns a novel nutritional supplement consisting of zinc, selenium and vitamin E in addition to the contents of the standard renal supplement of B and C vitamins.
This pilot randomized, double blind trial will compare 2 doses of the new supplement with the standard renal vitamin.
2.0 Objectives: Primary objective: compare two formulations of the new supplement (low and medium doses of zinc and selenium) with standard treatment (Replavite or equivalent renal vitamin).
Secondary objective: demonstrate the feasibility of recruitment for a definitive larger trial
- Conditions
- End Stage Renal Disease
- Being tested
- Low dose: supplemental zinc, selenium and vitamin E, Standard renal vitamin: B and C renal vitamin, Medium dose: supplemental zinc, selenium and vitamin E
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low dose: supplemental zinc, selenium and vitamin EDietary supplement
- ZINC 25mg (AS ZINC SULFATE)
- SELENIUM 50 mcg (AS SODIUM SELENITE)
- VITAMIN E (D-ALPHA-TOCOPHEROL) (AS SUCCINATE) 250 IU
Standard renal vitamin: B and C renal vitaminDietary supplement
Also called Replavite
- BIOTIN 300 MCG
- D-PANTOTHENIC ACID (CALCIUM D-PANTOTHENATE) 10 MG
- FOLIC ACID 1 MG
- NIACINAMIDE 20 MG
- VITAMIN B1 (THIAMINE MONONITRATE) 1.5 MG
- VITAMIN B12(CYANOCOBALAMIN) 6 MCG
- VITAMIN B2 (RIBOFLAVIN) 1.7 MG
- VITAMIN B6 (PYRIDOXINE HYDROCHLORIDE) 10 MG
- VITAMIN C (ASCORBIC ACID) 100 MG
- INERT FILLER (CORNSTARCH)
Medium dose: supplemental zinc, selenium and vitamin EDietary supplement
- ZINC 50 mg (AS ZINC SULFATE)
- SELENIUM 75 mcg (AS SODIUM SELENITE)
- VITAMIN E (D-ALPHA-TOCOPHEROL) (AS SUCCINATE) 250 IU
| Study group | Role | What they receive |
|---|---|---|
| Low dose | Experimental | Standard renal vitamin plus low dose zinc and selenium plus vitamin E
1 capsule p.o, daily Receives: Dietary Supplement: Low dose: supplemental zinc, selenium and vitamin E; Dietary Supplement: Standard renal vitamin: B and C renal vitamin |
| Medium dose | Experimental | Standard renal vitamin plus medium doses of zinc and selenium plus vitamin E
1 capsule p.o, daily Receives: Dietary Supplement: Standard renal vitamin: B and C renal vitamin; Dietary Supplement: Medium dose: supplemental zinc, selenium and vitamin E |
| Standard treatment | Active comparator | Standard renal vitamin
1 capsule p.o, daily Receives: Dietary Supplement: Standard renal vitamin: B and C renal vitamin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 90 days following baseline
Secondary outcomes (4)
Proportion of participants with zinc deficiency
The proportion of participants with zinc deficiency in each arm compared to each other arm at each time point.
Measured: 180 days following baseline
Proportion of participants with selenium deficiency
The proportion of participants with selenium deficiency in each arm compared to each other arm at each time point.
Measured: 90 days and 180 days following baseline
Zinc
Zinc concentration in each arm compared to each other arm.
Measured: 90 days and 180 days following baseline
Selenium
Selenium concentration measured in each arm compared to each other arm.
Measured: 90 days and 180 days following baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2011 (estimated)
- Study startNov 2012
- Primary completionDec 2013
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marcello Tonelli
- Sponsor type
- University, hospital or other
- Collaborators
- Alberta Health services
- Responsible party
- Sponsor-investigator, Marcello Tonelli, University of Alberta
- Investigators
- Marcello A Tonelli, MD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01473914
- Sponsor's protocol ID
- TRSV1
- Status last verified
- Dec 2016
- First submitted
- 23 Sep 2011
- Last updated
- 16 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 25884981Colombijn 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.
PubMed 37916745
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trace Element Replenishment Study in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT01473914
- Acronym / sponsor ID
- TRSV1
- Conditions
- End Stage Renal Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Marcello TonelliUniversity, hospital or other
- Collaborators
- Alberta Health services
- Study start
- Nov 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 17 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
People with severe kidney disease follow a restricted diet aimed at reducing intake of sodium, potassium and phosphate. These dietary restrictions require reducing their intake of many fresh fruits and vegetables, which may lead to nutritional deficiency. Although the potential for malnutrition in people with kidney disease is well recognized, blood levels of most vitamins and trace elements are rarely measured. Instead, most North Americans with severe kidney disease are routinely prescribed a "renal vitamin" such as Replavite which contains a mixture of B and C vitamins.
Recent evidence (including our work; see http://www.biomedcentral.com/bmcmed/subjects/nephrology) indicates that people with severe kidney disease are often deficient in several other biologically essential substances (selenium, zinc) that are readily amenable to supplementation. Pilot data from the Northern Alberta Renal Program (NARP) indicate that approximately 90% of patients have zinc levels below the lower limit of normal; findings for selenium are similar.
Potential benefits of zinc supplementation include improvements in immune function, taste sensitivity (perhaps reducing dietary sodium intake), and improved appetite. Potential benefits of selenium supplementation include reductions in the risk of vascular disease and infection. Supplementation with vitamin E was shown in a randomized trial to reduce serious cardiovascular morbidity in people with kidney failure, but is not routinely used in dialysis patients. This suggests that supplementation of zinc, selenium, and vitamin E has theoretical benefits in kidney failure. Since patients with kidney failure already take many medications, it is logical to combine any new nutritional supplements with the ingredients of the standard renal vitamin to reduce pill burden.
This protocol concerns a novel nutritional supplement consisting of zinc, selenium and vitamin E in addition to the contents of the standard renal supplement of B and C vitamins.
This pilot randomized, double blind trial will compare 2 doses of the new supplement with the standard renal vitamin.
2.0 Objectives: Primary objective: compare two formulations of the new supplement (low and medium doses of zinc and selenium) with standard treatment (Replavite or equivalent renal vitamin).
Secondary objective: demonstrate the feasibility of recruitment for a definitive larger trial
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low dose | Experimental | Dietary Supplement: Low dose: supplemental zinc, selenium and vitamin E, Dietary Supplement: Standard renal vitamin: B and C renal vitaminStandard renal vitamin plus low dose zinc and selenium plus vitamin E 1 capsule p.o, daily |
| Medium dose | Experimental | Dietary Supplement: Standard renal vitamin: B and C renal vitamin, Dietary Supplement: Medium dose: supplemental zinc, selenium and vitamin EStandard renal vitamin plus medium doses of zinc and selenium plus vitamin E 1 capsule p.o, daily |
| Standard treatment | Active comparator | Dietary Supplement: Standard renal vitamin: B and C renal vitaminStandard renal vitamin 1 capsule p.o, daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low dose: supplemental zinc, selenium and vitamin E1. ZINC 25mg (AS ZINC SULFATE) 2. SELENIUM 50 mcg (AS SODIUM SELENITE) 3. VITAMIN E (D-ALPHA-TOCOPHEROL) (AS SUCCINATE) 250 IU | Dietary supplement | Low dose |
| Standard renal vitamin: B and C renal vitaminAlso: Replavite1. 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) | Dietary supplement | Low dose, Medium dose, Standard treatment |
| Medium dose: supplemental zinc, selenium and vitamin E1. ZINC 50 mg (AS ZINC SULFATE) 2. SELENIUM 75 mcg (AS SODIUM SELENITE) 3. VITAMIN E (D-ALPHA-TOCOPHEROL) (AS SUCCINATE) 250 IU | Dietary supplement | Medium dose |
Primary outcome
Proportion of participants with zinc deficiency
Time frame: 90 days following baseline
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.
4 secondary outcomes
Proportion of participants with zinc deficiency
Time frame: 180 days following baseline
Proportion of participants with selenium deficiency
Time frame: 90 days and 180 days following baseline
Zinc
Time frame: 90 days and 180 days following baseline
Selenium
Time frame: 90 days and 180 days following baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2016.
- Results publication: PubMed 25884981Tonelli 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.
- Derived from this study: PubMed 37916745Colombijn 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.
- Published open access article with final resultsLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for End Stage Renal Disease
Recruiting
Dry Weight Reduction Intervention Via Extra Ultrafiltration
Fluid Accumulation, Blood Pressure Management
Not yet recruiting
Cycling During Dialysis: A Feasibility and Safety Study
Hemodialysis, Kidney Disease, End-Stage
Active, not recruitingPhase 2
Management of Iron Deficiency Anemia in Hemodialysis Patients
Iron Deficiency Anemia (IDA), ESRD (End Stage Renal Disease)
Not yet recruiting
Effects of Horticultural Therapy on Acute Stress and Salivary Cortisol Levels in Hemodialysis Patients
End-Stage Renal Disease, Renal Dialysis
RecruitingPhase 4
Empagliflozin in Heart Failure With Reduced Ejection Fraction and End Stage Renal Disease
Heart Failure With Reduced Ejection Fraction, End Stage Renal Disease on Dialysis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcello A Tonelli, MD principal investigator
University of Alberta
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Low dose: supplemental zinc, selenium and vitamin E, Standard renal vitamin: B and C renal vitamin and Medium dose: supplemental zinc, selenium and vitamin E in people with End Stage Renal Disease, run by Marcello Tonelli at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants with zinc deficiency (time frame: 90 days following baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01473914, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2016.