Polydextrose for Patients With Chronic Kidney Disease

NCT ID: NCT05336305

Last Updated: 2022-04-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-30

Study Completion Date

2021-10-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Constipation is a common complication in patients with chronic kidney disease (CKD), especially in hemodialysis (HD) patients. Reduced intake of fibre-rich food is among the most important causes of constipation. The study aims to investigate the possible influence of polydextrose (PDX) supplementation on constipation in patients with CKD on HD.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Kidney Diseases Constipation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Placebo Group

Administration of corn starch daily for 2 months

Group Type PLACEBO_COMPARATOR

Polydextrose

Intervention Type DIETARY_SUPPLEMENT

Administration of 3g polydextrose per day, for 2 months

polydextrose

Administration of 12g polydextrose daily for 2 months

Group Type EXPERIMENTAL

Polydextrose

Intervention Type DIETARY_SUPPLEMENT

Administration of 3g polydextrose per day, for 2 months

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Polydextrose

Administration of 3g polydextrose per day, for 2 months

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Clinical diagnosis of Chronic Kidney Disease
* Hemodialysis patients for more than 6 months
* Aged 18 years or older

Exclusion Criteria

* Patients pregnant
* Smokers
* Using antibiotics in the last 3 months
* Autoimmune diseases
* Clinical diagnosis of infectious diseases
* Clinical diagnosis of Cancer
* Clinical diagnosis of AIDS
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Universidade Federal Fluminense

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Denise Mafra

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Denise Mafra

Rio de Janeiro, Rio de Janeiro, Brazil

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Brazil

References

Explore related publications, articles, or registry entries linked to this study.

Borges NA, Sahiun E, Ribeiro-Alves M, Regis B, Mafra D. Effects of Polydextrose Supplementation on Intestinal Function in Hemodialysis Patients: A Double-Blind, Randomized, Placebo-Controlled Trial. J Ren Nutr. 2023 Nov;33(6):747-754. doi: 10.1053/j.jrn.2023.06.008. Epub 2023 Jun 14.

Reference Type DERIVED
PMID: 37321430 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

DeniseMafra15

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.