NCT01844882

Brief 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. 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2012

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

April 29, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 3, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

November 21, 2014

Status Verified

November 1, 2014

Enrollment Period

1.6 years

First QC Date

April 29, 2013

Last Update Submit

November 20, 2014

Conditions

Chronic Kidney Disease

Keywords

The effectsdietaryfiberkidney functionCKD patients

Outcome Measures

Primary Outcomes (2)

  • Creatinine

    1.5 years

  • urea

    1.5 years

Secondary Outcomes (1)

  • Phosphorus

    1.5 years

Study Arms (1)

Chronic Kidney Disease

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients with Chronic Kidney Disease (CKD)

You may qualify if:

  • Dietary trials in humans
  • Randomized treatment allocation
  • Suitable control (low fiber)
  • viable endpoint data

You may not qualify if:

  • Non-human studies
  • Nonrandomized treatment allocation
  • Lack of a suitable control (high protein)
  • no viable endpoint data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 25387901DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2013

First Posted

May 3, 2013

Study Start

January 1, 2012

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

November 21, 2014

Record last verified: 2014-11