Renal Insufficiency, ChronicPhase 3NCT02126293
Correction of Zinc Deficiency in Children With Chronic Kidney Disease and Kidney Transplant
A Phase 3 study testing Zinc Supplement and Repeat blood and urine tests in people with Renal Insufficiency, Chronic and Zinc Deficiency, run by Hamilton Health Sciences Corporation at 2 sites in Canada.
Trial summary
Children with chronic kidney disease, even after transplantation, may be at risk for bone problems due to an imbalance of calcium and phosphorus in the blood, especially as their kidneys progressively fail to function. Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Renal Insufficiency, Chronic, Zinc Deficiency, Trace Element Excess
- What is being tested?
- Zinc Supplement and Repeat blood and urine tests
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesCanada
- Study dates
- Sep 2014to Jan 2017
- 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 4 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children between 4 and 18 years of age; diagnosis of CKD; renal transplant recipient with declining renal function (eGFR<90 ml/min/1.73 m2).
Who cannot join
- Children with CKD or kidney transplant younger than 4 years. Kidney transplant recipients with eGFR>90 ml/min/1.73 m2.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
McMaster Children's Hospital
Hamilton, Ontario, L8S 4K1
Children's Hospital, London Health Science Centre University of Western Ontario
London, Ontario, N6A 5W9
About this study
Children with chronic kidney disease, even after transplantation, may be at risk for bone problems due to an imbalance of calcium and phosphorus in the blood, especially as their kidneys progressively fail to function. While some drug and diet treatments are available to prevent such bone disease, many children refuse to take them due to bad taste and tummy cramps. If calcium and phosphorus status remain abnormal for a long time, hard crystals can form in the blood vessels, eventually clogging them and resulting in heart problems. Investigators are studying possible new methods to help the kidneys maintain a normal balance of nutrients in the blood which is important for growing healthy bones and the prevention of side effects in blood vessels that can lead to heart disease. One method is to improve the team work of a hormone FGF-23 and a protein called Klotho that together stimulate the kidneys to increase phosphate removal. Investigators propose that this problem may be due to low blood zinc levels which often occur in children with kidney disease. Thus, in this study, investigators propose to first measure zinc in blood from children with chronic kidney disease (CKD) or who have had kidney transplants to assess zinc and phosphate status, the hormone FGF-23 and its assistant Klotho. If zinc status is low, the children will receive zinc supplementation for 3 months. After treatment with zinc, the same blood measurements will be repeated to determine if the zinc supplements have helped the hormones to remove phosphate from the body. If this pilot project is successful, investigators will then consider a larger scale project involving adult patients as well as pediatric patients from other pediatric centers. This project will also guide investigators as to whether they need to introduce zinc measurements as part of routine testing of CKD and transplant patients. In addition to measuring zinc levels in study participants, trace elements (TE) will also be measured. These include heavy metals such as cadmium, chromium, nickel, vanadium, copper, lead, manganese and selenium. Very little is known about levels and metabolism of TE in CKD especially before dialysis. In adults, cadmium, chromium, nickel, and vanadium probably accumulate in hemodialysis patients, while copper and lead may accumulate. Manganese, selenium are probably deficient. The study will allow investigators to obtain the information about TE in this group of pediatric patients.
- Conditions
- Renal Insufficiency, Chronic, Zinc Deficiency, Trace Element Excess, Trace Element Deficiency
- Being tested
- Zinc Supplement, Repeat blood and urine tests
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zinc SupplementDrug
Also called Zinc Lozenges,Douglas Laboratories,HC NPN 80032476
Repeat blood and urine testsProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Zinc deficient patients | Experimental | If the patient is found to be zinc deficient (serum zinc < 11.5 μmol/L), the family will be contacted by the RA to commence zinc supplement: zinc citrate (Zinc Lozenges, manufactured by Douglas Laboratories Inc, London, ON, Health Canada NPN 80032476) for 3 months. As per the NPN licence the dose is 10 mg (1 lozenge) orally once a day for children age 4-8 years, and 10 mg twice a day for children age 9-18 years. This should give enough time to restore serum zinc to normal in most patients. Receives: Drug: Zinc Supplement |
| Zinc sufficient patients | Active comparator | Zinc sufficient patients will repeat blood and urine tests in 3 month time to compare the changes with intervention arm. Receives: Procedure: Repeat blood and urine tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Establish proportion of zinc deficient children with chronic kidney disease and kidney transplant, who achieved correction of zinc deficiency after 3 months of zinc therapy
Measured: 3 months of therapy
Secondary outcomes (3)
Change in parameters of bone metabolism following zinc treatment in zinc deficient patients
Correlations between various parameters of bone metabolism, kidney function, zinc, FGF-23 and Klotho assessed by a multiple regression model. Change from baseline in FGF-23, Klotho, TE levels and phosphate excretion after zinc therapy analyzed by a paired t-test.
Measured: Baseline and 3 months
TE levels in zinc deficient children with chronic kidney disease and kidney transplant
Establish TE levels in zinc deficient children with chronic kidney disease and kidney transplant. Establish changes in TE levels following correction of zinc deficiency.
Measured: Baseline and 12 weeks
TE levels in zinc sufficient children with chronic kidney disease and kidney transplant
Establish TE levels in zinc sufficient children with chronic kidney disease and kidney transplant. Establish TE levels 12 weeks later as a quality control measure.
Measured: Baselne and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2014 (estimated)
- Study startSep 2014
- Primary completionJan 2017
- Study completionJan 2017
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 Renal Insufficiency, ChronicStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Collaborators
- London Health Sciences Centre
- Responsible party
- Sponsor
- Investigators
- Vladimir Belostotsky, MD, PhD (eq), Principal investigator, Hamilton Health Sciences Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02126293
- Sponsor's protocol ID
- ZICKD13-827
- Status last verified
- Mar 2017
- First submitted
- 30 Jan 2014
- Last updated
- 13 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Filler G, Taheri S, McIntyre C, Smith C, Subramanian L, Fusch G, Fusch C. Chronic kidney disease stage affects small, dense low-density lipoprotein but not glycated low-density lipoprotein in younger chronic kidney disease patients: a cross-sectional study. Clin Kidney J. 2018 Jun;11(3):383-388. doi: 10.1093/ckj/sfx115. Epub 2017 Oct 12.
PubMed 29992019Filler G, Kobrzynski M, Sidhu HK, Belostotsky V, Huang SS, McIntyre C, Yang L. A cross-sectional study measuring vanadium and chromium levels in paediatric patients with CKD. BMJ Open. 2017 Jun 6;7(5):e014821. doi: 10.1136/bmjopen-2016-014821.
PubMed 28592575
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correction of Zinc Deficiency in Children With Chronic Kidney Disease and Kidney Transplant
- ClinicalTrials.gov ID
- NCT02126293
- Acronym / sponsor ID
- ZICKD13-827
- Conditions
- Renal Insufficiency, Chronic, Zinc Deficiency, Trace Element Excess, Trace Element Deficiency
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Collaborators
- London Health Sciences Centre
- Study start
- Sep 2014 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 30 Apr 2014 (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.
Children with chronic kidney disease, even after transplantation, may be at risk for bone problems due to an imbalance of calcium and phosphorus in the blood, especially as their kidneys progressively fail to function. While some drug and diet treatments are available to prevent such bone disease, many children refuse to take them due to bad taste and tummy cramps. If calcium and phosphorus status remain abnormal for a long time, hard crystals can form in the blood vessels, eventually clogging them and resulting in heart problems. Investigators are studying possible new methods to help the kidneys maintain a normal balance of nutrients in the blood which is important for growing healthy bones and the prevention of side effects in blood vessels that can lead to heart disease. One method is to improve the team work of a hormone FGF-23 and a protein called Klotho that together stimulate the kidneys to increase phosphate removal. Investigators propose that this problem may be due to low blood zinc levels which often occur in children with kidney disease. Thus, in this study, investigators propose to first measure zinc in blood from children with chronic kidney disease (CKD) or who have had kidney transplants to assess zinc and phosphate status, the hormone FGF-23 and its assistant Klotho. If zinc status is low, the children will receive zinc supplementation for 3 months. After treatment with zinc, the same blood measurements will be repeated to determine if the zinc supplements have helped the hormones to remove phosphate from the body. If this pilot project is successful, investigators will then consider a larger scale project involving adult patients as well as pediatric patients from other pediatric centers. This project will also guide investigators as to whether they need to introduce zinc measurements as part of routine testing of CKD and transplant patients. In addition to measuring zinc levels in study participants, trace elements (TE) will also be measured. These include heavy metals such as cadmium, chromium, nickel, vanadium, copper, lead, manganese and selenium. Very little is known about levels and metabolism of TE in CKD especially before dialysis. In adults, cadmium, chromium, nickel, and vanadium probably accumulate in hemodialysis patients, while copper and lead may accumulate. Manganese, selenium are probably deficient. The study will allow investigators to obtain the information about TE in this group of pediatric patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Zinc deficient patients | Experimental | Drug: Zinc SupplementIf the patient is found to be zinc deficient (serum zinc < 11.5 μmol/L), the family will be contacted by the RA to commence zinc supplement: zinc citrate (Zinc Lozenges, manufactured by Douglas Laboratories Inc, London, ON, Health Canada NPN 80032476) for 3 months. As per the NPN licence the dose is 10 mg (1 lozenge) orally once a day for children age 4-8 years, and 10 mg twice a day for children age 9-18 years. This should give enough time to restore serum zinc to normal in most patients. |
| Zinc sufficient patients | Active comparator | Procedure: Repeat blood and urine testsZinc sufficient patients will repeat blood and urine tests in 3 month time to compare the changes with intervention arm. |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Children between 4 and 18 years of age; diagnosis of CKD; renal transplant recipient with declining renal function (eGFR<90 ml/min/1.73 m2).
Key exclusion criteria (1 listed)
- Children with CKD or kidney transplant younger than 4 years. Kidney transplant recipients with eGFR>90 ml/min/1.73 m2.
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 |
|---|---|---|
| Zinc SupplementAlso: Zinc Lozenges,Douglas Laboratories,HC NPN 80032476 | Drug | Zinc deficient patients |
| Repeat blood and urine tests | Procedure or surgery | Zinc sufficient patients |
Primary outcome
Establish proportion of zinc deficient children with chronic kidney disease and kidney transplant, who achieved correction of zinc deficiency after 3 months of zinc therapy
Time frame: 3 months of therapy
3 secondary outcomes
Change in parameters of bone metabolism following zinc treatment in zinc deficient patients
Time frame: Baseline and 3 months
TE levels in zinc deficient children with chronic kidney disease and kidney transplant
Time frame: Baseline and 12 weeks
TE levels in zinc sufficient children with chronic kidney disease and kidney transplant
Time frame: Baselne and 12 weeks
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 13 Mar 2017.
- Derived from this study: PubMed 29992019Filler G, Taheri S, McIntyre C, Smith C, Subramanian L, Fusch G, Fusch C. Chronic kidney disease stage affects small, dense low-density lipoprotein but not glycated low-density lipoprotein in younger chronic kidney disease patients: a cross-sectional study. Clin Kidney J. 2018 Jun;11(3):383-388. doi: 10.1093/ckj/sfx115. Epub 2017 Oct 12.
- Derived from this study: PubMed 28592575Filler G, Kobrzynski M, Sidhu HK, Belostotsky V, Huang SS, McIntyre C, Yang L. A cross-sectional study measuring vanadium and chromium levels in paediatric patients with CKD. BMJ Open. 2017 Jun 6;7(5):e014821. doi: 10.1136/bmjopen-2016-014821.
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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.
Vladimir Belostotsky, MD, PhD (eq) principal investigator
Hamilton Health Sciences Corporation
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 Zinc Supplement and Repeat blood and urine tests in people with Renal Insufficiency, Chronic and Zinc Deficiency, run by Hamilton Health Sciences Corporation 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 1 inclusion and 1 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 13 Mar 2017. 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?
Establish proportion of zinc deficient children with chronic kidney disease and kidney transplant, who achieved correction of zinc deficiency after 3 months of zinc therapy (time frame: 3 months of therapy). 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 NCT02126293, 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 13 Mar 2017.