Chronic Kidney DiseaseNCT01844882
The Effects of Dietary Fiber in CKD: A Systematic Review and Meta-analysis
An observational study of Chronic Kidney Disease, run by Unity Health Toronto.
Trial summary
Chronic kidney disease (CKD) is a debilitating condition in which there is a gradual decline of renal function associated with increased overall mortality. Most dietary guidelines for CKD focus on limiting protein intake (nitrogen) and high phosphorus-containing foods. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Kidney Disease
- How many people
- 1 participants
- Where
- No sites listed yet
- Study dates
- Jan 2012to Aug 2013
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients with Chronic Kidney Disease (CKD)
Who may be able to join
- Dietary trials in humans
- Randomized treatment allocation
- Suitable control (low fiber)
- viable endpoint data
Who cannot join
- Non-human studies
- Nonrandomized treatment allocation
- Lack of a suitable control (high protein)
- no viable endpoint data
About this study
Official title: The Effects of Dietary Fiber on Uremic Retention Solutes in CKD: A Systematic Review and Meta-analysis
Chronic kidney disease (CKD) is a debilitating condition in which there is a gradual decline of renal function associated with increased overall mortality. Most dietary guidelines for CKD focus on limiting protein intake (nitrogen) and high phosphorus-containing foods. However, increasing dietary fiber has been proposed to increase fecal nitrogen excretion which may ameliorate the progress of CKD. We therefore plan to conduct a systematic review and meta-analysis on clinical trials to assess the effect of fiber on urea and creatinine as classical markers of a state of uremia in individuals with CKD. We hypothesize that increasing fiber intakes will improve urea and creatinine levels in individuals with CKD.
- Conditions
- Chronic Kidney Disease
- Keywords
- The effects, dietary, fiber, kidney function, CKD patients
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Chronic Kidney Disease | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Creatinine
Measured: 1.5 years
urea
Measured: 1.5 years
Secondary outcomes (1)
Phosphorus
Measured: 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2013 (estimated)
- Study startJan 2012
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe sponsor's other registered studies.
- 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
- Observational
- Time perspective
- Retrospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01844882
- Sponsor's protocol ID
- SMH-CKD-2013
- Status last verified
- Nov 2014
- First submitted
- 29 Apr 2013
- Last updated
- 21 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Chiavaroli L, Mirrahimi A, Sievenpiper JL, Jenkins DJ, Darling PB. Dietary fiber effects in chronic kidney disease: a systematic review and meta-analysis of controlled feeding trials. Eur J Clin Nutr. 2015 Jul;69(7):761-8. doi: 10.1038/ejcn.2014.237. Epub 2014 Nov 12.
PubMed 25387901
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Dietary Fiber on Uremic Retention Solutes in CKD: A Systematic Review and Meta-analysis
- ClinicalTrials.gov ID
- NCT01844882
- Acronym / sponsor ID
- SMH-CKD-2013
- Conditions
- Chronic Kidney Disease
- Keywords
- The effects, dietary, fiber, kidney function, CKD patients
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 3 May 2013 (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.
Chronic kidney disease (CKD) is a debilitating condition in which there is a gradual decline of renal function associated with increased overall mortality. Most dietary guidelines for CKD focus on limiting protein intake (nitrogen) and high phosphorus-containing foods. However, increasing dietary fiber has been proposed to increase fecal nitrogen excretion which may ameliorate the progress of CKD. We therefore plan to conduct a systematic review and meta-analysis on clinical trials to assess the effect of fiber on urea and creatinine as classical markers of a state of uremia in individuals with CKD. We hypothesize that increasing fiber intakes will improve urea and creatinine levels in individuals with CKD.
Study design
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic Kidney Disease | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients with Chronic Kidney Disease (CKD)
Key inclusion criteria (4 listed)
- Dietary trials in humans
- Randomized treatment allocation
- Suitable control (low fiber)
- viable endpoint data
Key exclusion criteria (4 listed)
- Non-human studies
- Nonrandomized treatment allocation
- Lack of a suitable control (high protein)
- no viable endpoint data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Creatinine
Time frame: 1.5 years
urea
Time frame: 1.5 years
1 secondary outcome
Phosphorus
Time frame: 1.5 years
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 21 Nov 2014.
- Derived from this study: PubMed 25387901Chiavaroli L, Mirrahimi A, Sievenpiper JL, Jenkins DJ, Darling PB. Dietary fiber effects in chronic kidney disease: a systematic review and meta-analysis of controlled feeding trials. Eur J Clin Nutr. 2015 Jul;69(7):761-8. doi: 10.1038/ejcn.2014.237. Epub 2014 Nov 12.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Disease, run by Unity Health Toronto.
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 4 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 21 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
Creatinine (time frame: 1.5 years). The study lists 2 primary outcomes in all. 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 NCT01844882, which also lists 1 linked publication.
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 21 Nov 2014.